Compliance with In-Home Administration of Sprinkles among Caregivers in Guatemala
By
Bronwyn Mariella Sinclair BA, Brigham Young University
A thesis submitted to the Hubert Department of Global Health Rollins School of Public Health Emory University in partial fulfillment of the requirements for the degree of Master of Public Health May 2008
Compliance with In-Home Administration of Sprinkles among Caregivers in Guatemala
Approved:
________________________________________________________ Rafael Flores, Dr.PH, Thesis Advisor
________________________________________________________ Date
________________________________________________________ Roger Rochat, M.D., Director of Graduate Programs, Hubert Department of Global Health
________________________________________________________ Date
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In presenting this thesis as a partial fulfillment of the requirements for an advanced degree from Emory University, I agree that the Rollins School of Public Health shall make it available for inspection and circulation in accordance with its regulations governing material of this type. I agree that permission to copy from, or to publish, this report may be granted by the professor under whose direction it was written, or, in his/her absence, by the Department Chair of the Hubert Department of Global Health when such copying or publication is solely for scholarly purposes and does not involve potential financial gain. It is understood that any copying from, or publication of, this report which involves potential financial gain will not be allowed without permission.
_______________________________________________ Bronwyn Mariella Sinclair
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Bronwyn Mariella Sinclair
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Acknowledgements I would like to thank my advisor Rafael Flores for his guidance and support while conducting my research in Guatemala and in writing this thesis, and especially for seeing me through the many obstacles I encountered along the way. A special thanks to Francisco Chew for his mentorship and support in the field. His advice was indispensible and much appreciated. I also extend my gratitude to Erick Boy at the Micronutrient Initiative, and to Ivan Mendoza and Viviana Rendón at the Guatemalan Ministry of Health’s Nutritional Food Security Program (PROSAN) for their continued collaboration and for making this study possible. Finally, I would like to thank my parents for their unfailing support and encouragement, and my grandmothers for always believing in me. This thesis is dedicated to the women and children in Alta Verapaz who welcomed me into their homes and graciously shared their thoughts and experiences with me.
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Abstract Background. Vitamin and mineral deficiency (VMD) affects millions of children around the world. Syrups, tablets and drops have commonly been used for treating iron deficiency anemia (IDA) in young children, but they have resulted in poor compliance by caregivers. Micronutrient Sprinkles, single serving size sachets containing powdered iron and other micronutrients, are equally effective in treating IDA. Previous studies have shown that compliance by caregivers to administer Sprinkles to their children has been varied, and none of these studies have taken place in Latin America. Objective. The purpose of this study was to assess compliance by caregivers participating in a Sprinkles pilot study in Alta Verapaz, Guatemala to determine whether Sprinkles is an appropriate intervention for this population. Specific objectives include: Evaluating differences in compliance between health districts and determining the factors which influence compliance in this population, such as the length of time that caregivers were given to comply, whether instructions for administration of Sprinkles were given to the caregivers, socioeconomic status, Spanish ability, education level and attitudes and opinions about the pilot study. Methods. Caregivers with children 6-59 months of age who had received Sprinkles at health facilities in Tactic, Santa Cruz Verapaz and Tucurú between February and April 2007 were eligible for participation in the study. A total of 347 caregivers were selected from the health facilities using proportional stratified sampling. Survey-based interviews were conducted in the caregivers’ homes with the help of Q'eqchi' and Poqomchi' translators. Data was analyzed utilizing SAS software. Results. Overall compliance was 84.4%. Tucurú had a higher rate of compliance than Tactic and Santa Cruz (97.5%), and the difference between health districts was significant (P=<.0001). Caregivers in Tucurú also had the lowest Spanish ability and socioeconomic status. These two factors were found to be predictive of compliance (P=.0064 and <.0001). The duration between the receipt of Sprinkles and the interview did not affect compliance (P=.0578). Most caregivers (98.1%) received instructions on proper administration of Sprinkles; whether or not instructions were given did not influence compliance (p=value=.4077). Most caregivers also believed that Sprinkles was helping the child (76.7%) and that the sachets were easy to administer (79.1%), but positive attitudes and opinions about Sprinkles were highest in Tucurú. The majority did not experience difficulties with administration to the child (61.5%), however the most common difficulties cited were: forgetting to add Sprinkles to the food, that the child did not like the taste, and that the food changed color. Discussion. Compliance by caregivers was high in all three health districts, and Sprinkles were generally liked and accepted. Compliance was particularly high in Tucurú, which was the most rural and poverty-stricken of the three health districts. Sprinkles distribution would be most beneficial in areas that are similar to Tucurú; Rural areas with a low SES are found in much of Guatemala, and they are generally the most in-need of nutrition interventions. The conclusion is that Sprinkles is an appropriate intervention for Guatemala. Distribution should occur at the national level, but maintain a focus on lower income and rural populations.
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Table of Contents
List of Tables ................................................................................................................... viii List of Figures .................................................................................................................... ix Introduction....................................................................................................................... 1 Purpose of the Study ........................................................................................................... 4 Literature Review ............................................................................................................. 5 Vitamin and Mineral Deficiencies(VMD) .......................................................................... 5 Iron Deficiency ................................................................................................................... 5 Nutritional status in Guatemala .......................................................................................... 6 Interventions ....................................................................................................................... 7 Micronutrient Sprinkles ...................................................................................................... 9 Compliance with Sprinkles ............................................................................................... 10 Side Effects ....................................................................................................................... 12 Other Issues....................................................................................................................... 14 Flexible Administration .................................................................................................... 15 Qualitative Data ................................................................................................................ 15 Methods............................................................................................................................ 16 Project Background and Context ...................................................................................... 16 Study Site and Population................................................................................................. 18 Sample Size Calculation and Sampling Methodology...................................................... 18 Interviews.......................................................................................................................... 20 Survey Instrument............................................................................................................. 20 Data Analysis .................................................................................................................... 21 Ethical Considerations ...................................................................................................... 22 Results .............................................................................................................................. 22 Demographic Information................................................................................................. 22 Socioeconomic Status (SES)............................................................................................. 23 Compliance ....................................................................................................................... 24 Correct Administration ..................................................................................................... 27 Attitudes and Opinions about Sprinkles ........................................................................... 28 Summary ........................................................................................................................... 30 Discussion......................................................................................................................... 31 Findings............................................................................................................................. 31 Limitations ........................................................................................................................ 34 Recommendations and Conclusion................................................................................... 35 Appendix A: Guatemala Sprinkles Compliance Survey. ............................................ 37
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List of Tables
Table 1: Compliance with Sprinkles Reported in Previous Studies. ............................... 11 Table 2: Health Facilities Participating in the Sprinkles Pilot Study............................... 17 Table 3: Sample Size Calculation and Adjustment for Non-Response. .......................... 18 Table 4: Proportion and Number of Caregivers Interviewed in Each Health Facility......19 Table 5: Demographic Information of Caregivers Participating in the Sprinkles Pilot Study. ................................................................................................................. 23 Table 6: Mean Socioeconomic Status (SES) of Caregivers in Each Health Facility and Health District.................................................................................................... 24 Table 7: Compliance among Caregivers Stratified By the Health Facility Where the Child Received Sprinkles................................................................................... 26 Table 8: Caregiversâ&#x20AC;&#x2122; Responses to Why Sprinkles are Important for the Child.............. 28 Table 9: Caregiversâ&#x20AC;&#x2122; Reported Difficulties with Administration of Sprinkles. ............... 29
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List of Figures Figure 1: Conceptual Framework: Influential Factors and Outcomes of Compliance. ... 3 Figure 2: Location of Health Districts Where the Sprinkles Pilot Study Was Conducted. ...................................................................................................... 17 Figure 3: Compliance Among Caregivers Stratified By the Health District Where the Child Received Sprinkles................................................................................ 25 Figure 4: Time Elapsed Between the Receipt of Sprinkles and the Interview among Caregivers. ...................................................................................................... 27
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Introduction The nutritional status of children in Guatemala is the worst of all Latin American countries. Vitamin and mineral deficiencies (VMD)—particularly iron deficiency anemia (IDA)—is a major public health concern. To address this issue, Guatemala’s Ministry of Health has been distributing ferrous sulfate (iron) syrup to children at local health centers and health posts nationwide in order to treat anemic children. While no studies have been conducted in Guatemala to assess the rate of compliance with syrup, the general feeling is that compliance with in-home administration of the syrup is low. This has also been the case in many other countries that have implemented similar interventions (Abou-Zahr, 1990). Micronutrient Sprinkles are small packets of powdered iron and other essential nutrients that have been successful in reducing iron deficiency and IDA in other countries (S.H. Zlotkin, Christofides, Hyder, Schauer, & al., 2004). The Ministry of Health of Guatemala, with assistance from the Micronutrient Initiative, conducted a pilot study in the province of Alta Verapaz to determine whether Sprinkles is a good option for replacement of the ferrous sulfate syrup for distribution in the government-funded health facilities. The pilot study took place between September 2006 and December 2007. Three health districts—Tactic, Tucurú and Santa Cruz Verapaz—were included in the pilot study, with the goal of nationwide expansion of the project if the pilot proved to be successful. All children 6 to 59 months of age attending the health facilities in the districts aforementioned were eligible for enrollment. While a handful of studies have looked at compliance with Sprinkles by caregivers, the results of these studies have varied greatly. This suggests that compliance rates differ
1
according to the population in which the intervention is occurring. Therefore an assessment of compliance in Guatemala was needed to determine whether Sprinkles is an appropriate intervention for this setting, given local cultural, behavioral and food consumption norms, and to provide insight about the impact of distribution at the national level. An exploration of the factors that influence compliance would also be instrumental in improving the operational effectiveness of the intervention, if it were to be implemented nationally. If compliance is high, national implementation of the project could lead to a significant reduction in cognitive impairment due to iron deficiency and increase physical and work performance, thereby improving the overall health of children throughout Guatemala. As of April 2008, no plans for continuation of the project or for its expansion have been made. Still, much can be learned from the implementation of the pilot study with regard to compliance by caregivers to give the Sprinkles to their children. A better understanding of the influential factors on compliance can also be gained as a result of the pilot study. Figure 1 depicts some of the factors believed to impact compliance with Sprinkles, as well as the positive health outcomes which stem from it.
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Figure 1: Conceptual Framework: Influential Factors and Outcomes of Compliance.
Instructions received for administration
Knowledge
Sprinkles distribution/ availability
Socio-cultural Issues
Level of education/ Spanish ability
Traditions and beliefs
Time given for administration to child
Health status/ condition of child
Food consumption norms
Compliance
Treatment of undetected cases
Prevention of anemia and iron deficiency
Increased physical and work performance
Project implementation on a national scale
Reduction of cognitive impairment due to deficiency
Improved overall child health in Guatemala Key Causal relationship Non-causal relationship
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Purpose of the Study The primary objective is to determine the extent to which caregivers participating in the Sprinkles pilot study are complying with in-home administration of Sprinkles to their child(ren) in three health districts of Alta Verapaz, Guatemala.
The specific objectives are: •
To evaluate whether compliance differed depending on the health district and health facility where the child received Sprinkles.
•
To determine whether the amount of time that caregivers were given to finish the 60 doses of Sprinkles influenced compliance.
•
To determine the specific instructions for in-home administration of Sprinkles given to caregivers by health personnel upon receipt of Sprinkles, whether instructions were understood and its effect on compliance.
•
To assess the association between compliance and socioeconomic status, Spanish ability, level of education, and attitudes and opinions about the Sprinkles project.
4
Literature Review Vitamin and Mineral Deficiencies (VMD) About one-third of the worldâ&#x20AC;&#x2122;s population suffers from VMD. (Micronutrient Initiative & UNICEF, 2004). Millions of children and adults alike have experienced impaired growth and development and diminished overall well-being as a result of VMD. However, VMD is not always evident to the naked eye, and the people it affects are frequently unaware of the deficiency. For this reason, it is commonly known as â&#x20AC;&#x153;hidden hunger.â&#x20AC;? According to the World Health Organization, iron deficiency, vitamin A deficiency and zinc deficiency are among the top 26 major risk factors of the global burden of disease (WHO, 2002). Over one-half of children in developing countries ages 6 to 24 months are deficient in iron (Micronutrient Initiative & UNICEF, 2004). Measles and diarrhea associated with vitamin A deficiency account for more than 800,000 deaths worldwide (Micronutrient Initiative & UNICEF, 2004), and zinc deficiency is said to be responsible for 16 percent of lower respiratory tract infections, 18 percent of malaria and 10 percent of diarrheal disease (Rice, West Jr., & Black, 2004). Children in developing countries often bear the majority of this burden, as they are most susceptible to illness and death associated with VMD. Iron Deficiency Iron deficiency is the most common cause of anemia in developing countries. Bhutta and colleagues estimate that iron deficiency anemia (IDA) causes 1.6 million disabilityadjusted life years (DALYs) in children under the age of five (Bhutta et al., 2008). Children under five years of age who have iron deficiency or iron deficiency anemia (IDA) are at risk for experiencing long-term consequences as a result of the deficiency,
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including irreversible cognitive impairment and diminished physical and work performance as adults. An economic analysis of ten countries identified yearly physical productivity losses as a result of iron deficiency to be about $0.57 of the gross domestic product, or $0.32 per head (Zimmerman & Hurrell, 2007). Nutritional status in Guatemala Because stunting, or height-for-age, is one of the few visual signs of undernutrition, it has long been used as a measure of nutritional status in developing countries. An analysis of 388 national surveys from 139 countries showed that 16.1 percent of children under five years of age in Latin America are stunted (R. E. Black et al., 2008). Central American countries have the highest combined prevalence of stunting within the Latin American and Caribbean region (23.5 percent) and the rate of improvement is the lowest at only 10 percent per year (Bryce, Coitinho, Darnton-Hill, Pelletier, & Pinstrup-Andersen, 2008). The stunting prevalence in Guatemala far exceeds that of the other countries in the region at 44.2 percent, though some areas report rates of up to 69 percent (INE, 2000). Data compilation from nine countries in Latin America shows that micronutrient deficiencyâ&#x20AC;&#x201D;particularly anemiaâ&#x20AC;&#x201D;is the primary form of malnutrition in the region (Llanos, Teresa Oyarzun, Bonvecchio, J, & Uauy, 2007). This is the case in Guatemala. The Ministry of Health reports that 42 percent of children are anemic (ENSMI, 2002; INE, 2002). Rates of iron deficiency are expected to be much higher. Ruel and colleagues detected a significant reduction (67 percent) in the percentage of children who had persistent diarrhea when zinc supplements were given, indicating that zinc deficiency is also a concern (Ruel, Rivera, Santizo, Lonnerdal, & Brown, 1997). 15 percent of children in Guatemala are also vitamin A deficient (PAHO, 2007).
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Orozco et al. explains that the reason for these deficiencies in the population is the Guatemalan diet, which consists mainly of maize and legumes (Orozco, Solomons, & Briend, 2006). Fruits, vegetables and other cereals often complement these staples but consumption of animal products is low. Therefore the Guatemalan diet contains insufficient amounts of some micronutrients, while other that are present in the diet have low bioavailability (Orozco et al., 2006). Among children, VMD becomes of concern when children begin to consume complementary foods. During the first six months of life, exclusive breastfeeding guarantees that an infant receives the required amount of iron, zinc and other micronutrients (Silva, Vitolo, Zara, & Castro, 2006). But after complementary foods are introduced, childrenâ&#x20AC;&#x2122;s intake of essential nutrients is slowed. VMD in children is a contributing factor to Guatemalaâ&#x20AC;&#x2122;s poor health statistics. Diarrhea and acute respiratory infections are the two leading causes of death for children under 5 years of age, and infant mortality and under 5 mortality are higher in Guatemala than in any other Central American country (PAHO, 2007). Interventions Several recent studies have demonstrated that vitamin and mineral interventions are among the best and most cost-effective ways to achieve the Millennium Development Goals (R.E. Black, Morris, & Bryce, 2003; Bryce et al., 2005; Tan Torres et al., 2005). Diet diversification, fortification of complementary foods and supplementation are the three most commonly used interventions to treat VMD. Diet diversification, however, is difficult to implement because often nutrient-rich foods are not available to the target population. Additionally, people are unlikely to change what they eat because food is often a part of culture and tradition. Fortification of complementary foods has been 7
successful in some countries like Chile, although there is some question as to whether it benefits the micronutrient status of young children (Bhutta et al., 2008). Zimmerman & Hurrell report that while a milk-based fortification program benefitted children in Chile, a similar intervention in Mexico showed no change in iron status (Zimmerman & Hurrell, 2007). Imhoff-Kunsch, et al. assessed the impact of wheat flour fortification with iron and folic acid in Guatemala. She describes that the rural poor do not consume bread on a regular basis, so fortification likely does not benefit them. Most of the rural poor eat corn tortillas that are often ground at village mills, making fortification difficult. Additionally, corn flour contains large amounts of phytic acid which inhibits iron absorption, so it is not a good vehicle for fortification. She also states that small children still breastfeeding are not benefiting from fortification because they are not consuming ideal amounts of staple foods (Imhoff-Kunsch, Flores, Dary, & Martorell, 2007). Supplementation is probably the best available intervention to address VMD because it can be targeted to specific population groups (Mora, 2002). In countries like Guatemala where a large proportion of the population is rural and outside the reaches of fortification, supplementation is the only feasible way to get essential nutrients to the people. It is also the best option for young children because they eat very little, and it is not always possible to change their diets to consume fortified products. Baltussen, et al. found that iron supplementation benefited population health more than fortification. However, supplementation is less cost-effective than fortification (Baltussen, Knai, & Sharan, 2004). Reasons for this include problems with distribution and low compliance (Gross, Mamani Diaz, & Valle, 2006).
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Non-compliance is one of the main reasons for the ineffectiveness of iron supplementation interventions (Winichagoon et al., 2006); (Galloway & McGuire, 1994; Gross, Mamani Diaz, & Valle, 2006). This is because tablets are difficult for young children to swallow and drops and syrups have an unpleasant taste and can stain teeth (Mora, 2002). To address this issue, complementary food supplements that are added directly to the childâ&#x20AC;&#x2122;s food have been developed (Zimmerman & Hurrell, 2007). Utilization of these supplements is known as â&#x20AC;&#x153;home fortification.â&#x20AC;? They are available in three forms: Water-dispersible or crushable tablets, energy-dense spreads, and Sprinkles (Adu-Afarwuah et al., 2007; Mannar, 2006; Zimmerman & Hurrell, 2007). Micronutrient Sprinkles Micronutrient Sprinkles were designed primarily to address anemia in children. They are individually packaged serving-size sachets containing iron and other essential nutrients (zinc, vitamin A, vitamin C and folic acid) in powder form. They are mixed into precooked homemade foods and they do not significantly alter the taste, color or texture of the food. This makes administration easier for caregivers because it eliminates the possibility of resistance by young children. Sprinkles are as efficacious as iron drops for treating childhood anemia (S.H. Zlotkin et al., 2004). Randomized controlled trials have proven that Sprinkles reduces anemia in children under 5 years of age by 30 to 50 percent when 60 doses are administered between 60 and 120 days (S.H. Zlotkin, Schauer, Christofides, Sharieff, & al., 2005). A study in Ghana found a 20 percent reduction in zinc deficiency when Sprinkles were administered over the course of two months (S.H. Zlotkin, Arthur, Schauer, Antwi, & al., 2003). This demonstrates that while the zinc contained in Sprinkles has a low
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bioavailability, children are still able to absorb an adequate amount (S. H. Zlotkin et al., 2006). Additionally, iron absorption in Sprinkles is not affected by zinc or ascorbic acid (vitamin C) (S. H. Zlotkin et al., 2006). Iron absorption also meets and surpasses requirements for absorbed iron in infants when Sprinkles are added to a maize-based porridge (Tondeur et al., 2004). This is important to note, as maize is also a main staple food in Guatemala. Sprinkles are also cost-effective. For a low-income country (GDP per capita = $417), Sharieff, et al. estimated that the cost per death averted as a result of zinc contained in Sprinkles is about $406 per year and the cost per DALY (disability-adjusted life year) saved is roughly $12.2 (Sharieff, Horton, & Zlotkin, 2006). The gain in earnings due to higher cognitive functioning for each dollar spent as a result of the iron in Sprinkles is about $37 (Sharieff, Horton et al., 2006). Compliance with Sprinkles Because compliance with supplementation interventions has historically been low, assessing compliance with Sprinkles administration quickly became a priority after the efficacy of the intervention was determined. Zlotkin and colleagues found a collective 70 percent compliance rate 1 in the initial efficacy trials (S.H. Zlotkin et al., 2004). Since then, other studies have shown higher rates of compliance. Table 1 shows all Sprinkles studies that have been conducted in which compliance was one of the outcomes assessed. 2 In this table, we see that compliance rates in the different studies varied between 42 and 98 percent. However, none of the studies have assessed the reason for the variation in compliance between the studies. 1
Rate of compliance calculated by the number of sachets consumed, divided by the total number of sachets provided for the given time period. 2 Only studies for which the results are published have been included in the table.
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Table 1: Compliance with Sprinkles Reported in Previous Studies. Country
Target Population
Compliance Rate (%)
Time period
Taste/ Smell/ Color Alteration
Side Effects
Bangladesh
Children 6 to 24 months
--
Children 6 to 18 months
2 month 3 month 4 month 12 months
No/Mild
Cambodia
88% 93% 98% --
No
Canada
Children 4 to 18 months Schoolchildr en 3 to 6 years old Children 6 to 18 months Children 8 to 20 months Children 6 to 18 months Children 6 to 18 months
59.6%
6 months
--
86%
13 weeks
No
Minimal stool darkening, diarrhea, constipation, vomiting -76.9 % (diarrhea+ vomiting + stool darkening) No
[83% ≥ 4 d/wk] [ 80% ≥ 4 d/wk] [82.1% ≥ 5 d/wk] 83-85%
2 months
No
-12.8% (diarrhea)
-16%
6 months
--
-
--
-3.4%
2 months
-2% (odor) -65.7% (color) -1.8% (odor) -80.5% (color) --
(S. Zlotkin, Arthur, Antwi, & Yeung, 2001) (S. Zlotkin, Antwi, Schauer, & Yeung, 2003) (S. H. Zlotkin et al., 2003)
--
(Christofides et al., 2006)
Children 6 to 12 months Children 9 to 24 months Children 6 to 18 months
85.8%
6 months
--
-50-59% (stool darkening) -Minimal diarrhea, teeth staining --
--
(Adu-Afarwuah et al., 2007)
96%
2 months
--
--
--
(Menon et al., 2007)
42-62%
2 months
--
--
(Hirve et al., 2007)
Children 6 to 12 months
60%
2 months
--
-38.3-69.3% (stool darkening) -1.3-6.8% (teeth staining) -Minimal vomiting, diarrhea No
--
(Sharieff, Bhutta, Schauer, Tomlinson, & Zlotkin, 2006)
China
Ghana I Ghana II Ghana III Ghana IV
Ghana V Haiti India
Pakistan
2 months
Problems giving child Sprinkles? --
Source
--
(Giovannini et al., 2006)
--
(Christofides, Schauer, Sharieff, & Zlotkin, 2005) (Sharieff, Yin, Wu, Yang, & al., 2006)
--
1%
(Ip, Hyder, Haseen, Rahman, & Zlotkin, 2007)
In some of the studies, high compliance rates may be confounded by the fact that the Sprinkles were distributed through systems that were already in place at the time that the intervention occurred. For example, in China, schools were used for Sprinkles distribution, and teachers were in charge of making sure that the food containing Sprinkles was consumed (Sharieff, Yin et al., 2006). This study demonstrated that Sprinkles can be effective if incorporated as a school based program. In Haiti, Sprinkles distribution was incorporated into a pre-existing health and nutrition program in which caretakers received a wheat-soy blend for their children (Menon et al., 2007). Pairing up the distribution of Sprinkles with that of the wheat-soy blend may have played a hand in the high compliance found with Sprinkles (96 and 97 percent with Sprinkles and wheatsoy blend, respectively). Additionally, pre-existing program staff were used to instruct caregivers about the appropriate use of Sprinkles (Menon et al., 2007). This might have also contributed to the high compliance rate. Side Effects There has been some information in the literature with regard to the reasons for noncompliance with Sprinkles administration. Five of the twelve studies listed in Table 1 reported side effects associated with Sprinkles administration, including stool darkening, tooth staining, vomiting and diarrhea. Stool darkening was common in one study in Ghana (50-59 percent) and also in India (38.3-69.3 percent) (Christofides et al., 2006; Hirve et al., 2007). All other side effects occurred only minimally, however an earlier study in Ghana reported diarrhea prevalence at 12.8 percent (S. Zlotkin et al., 2001). In Canada, 76.9 percent of participants reported side effects (Christofides et al., 2005), but
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the authors did not specify what percentage was due to diarrhea, vomiting or stool darkening. Some of the studies also compared side effects associated with different formulations of Sprinkles against iron drops. Side effects associated with the drops were consistently higher than with Sprinkles. (Christofides et al., 2006; Hirve et al., 2007; S. Zlotkin et al., 2003; S. Zlotkin et al., 2001). The caregivers in three of the Ghanaian studies also reported that they liked Sprinkles more than the iron drops and/or that Sprinkles were easier to use than the drops (Christofides et al., 2006; S. Zlotkin et al., 2003; S. Zlotkin et al., 2001). Finally, compliance with Sprinkles was higher than with drops in the second Ghanaian study (83-85 percent versus 69 percent) (S. Zlotkin et al., 2003), as well as among most groups receiving Sprinkles in the Indian study (Hirve et al., 2007). Some alterations in the taste or color of the food have been reported in two of the Ghanaian studies (S. Zlotkin et al., 2003; S. H. Zlotkin et al., 2003). While alterations in taste have been minimal (2 percent and 1.8 percent), changes in the color of the food were more frequent (67.5 percent and 80.5 percent). Studies in Bangladesh, Cambodia, China and the first study in Ghana reported no such alterations (Giovannini et al., 2006; Ip et al., 2007; Sharieff, Yin et al., 2006; S. Zlotkin et al., 2001). Whether or not a child consumes the full dose of Sprinkles has also been a concern to researchers. In the third study in Ghana, 69.7 percent of caregivers reported using the full contents of the sachet all of the time (S. H. Zlotkin et al., 2003). In an earlier study, 99.7 percent of Ghanaian caretakers reported using the entire contents of the sachet on the childâ&#x20AC;&#x2122;s food and reported that the child ate all of the food to which Sprinkles were added (S. Zlotkin et al., 2003). This was also the case in Haiti, where over 95 percent stated that
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they used the entire sachet each time they administered Sprinkles, that they mixed Sprinkles into solid or semi-solid foods, and that the child consumed all the food containing Sprinkles (Menon et al., 2007). All Bangladeshi caretakers studied reported mixing the full content of sachets into the food before serving, and over 90 percent reported that their child ate the entire amount of food containing Sprinkles at each meal (Ip et al., 2007). Sharing food with non-study children did not appear to be an issue, with less than three percent of caretakers reporting sharing in four different studies (Ip et al., 2007; Sharieff, Bhutta et al., 2006; S. Zlotkin et al., 2003; S. H. Zlotkin et al., 2003). Other Issues Other reasons for non-compliance with Sprinkles were discussed in two of the studies. In India, child illness played a major role in the discontinuation of Sprinkles administration. Hirve et al. states that caretakers often stopped giving Sprinkles to the child if illness such as diarrhea, fever or respiratory illnesses occurred (Hirve et al., 2007). In the last study in Ghana, the main reasons that mothers did not give their child the Sprinkles was child illness, mother forgetting to add Sprinkles to the food, and the child refusing to eat the food containing Sprinkles (Adu-Afarwuah et al., 2007). Additional reports in Ghana indicate that either caretakers or children disliked the Sprinkles, however in most cases this has been minimal. In the second study, 6.5 percent mothers objected to taking the Sprinkles (S. Zlotkin et al., 2003). Two studies identified less than 3.4 percent and less than one percent of mothers who reported they had problems with the administration of Sprinkles (S. Zlotkin et al., 2003; S. H. Zlotkin et al., 2003). Results from the first study in Ghana produced a much higher frequency, with 16 percent of caretakers reporting problems with giving their child Sprinkles (S. Zlotkin et
14
al., 2001). The main reason was that the children did not want to eat the food to which the Sprinkles was added, though the researchers did not specify whether caretakers believed this was due to a taste, color or smell alteration. Flexible Administration While daily administration of Sprinkles has been the norm in most of the studies, Ip and colleagues decided to test daily administration against flexible administration, to see whether flexible administration resulted in higher rates of compliance. Children who consumed 60 sachets of Sprinkles over four months were the most compliant (98 percent), followed by those who consumed 60 sachets over three months (93 percent) (Ip et al., 2007). Children who were to consume Sprinkles daily for two months had significantly lower compliance (88 percent). Caretakers stated that they preferred flexible administration over daily, and found instructions for flexible administration clear and easy to follow. Additionally, the group that was given four months to consume the 60 sachets had better hematological outcomes. 3 Qualitative Data The Bangladesh study also incorporated focus group discussions (FGDs) into the study. In the FGDs, most caregivers reported positive changes in their child’s behavior, such as increased appetite, and increased activity and playfulness (Ip et al., 2007). Sixty percent of mothers ‘extremely liked” the Sprinkles intervention, while 30 percent and 10 percent ‘liked’ and ‘somewhat liked’ it (respectively) (Ziauddin Hyder, Haseen, Rahman, & Zlotkin, 2004). Some of the major reasons that caregivers liked the Sprinkles were that
3
This could be because of higher adherence or because less frequent consumption might have led to greater iron absorption and retention.
15
they were ‘easy to use,’ ‘encouraged regular weaning,’ ‘encouraged children to eat more.’ No published material assessing compliance with Sprinkles in Latin America could be found in the literature. Only one study on Sprinkles in Bolivia was found (S. Zlotkin, 2004), however compliance was not an outcome of interest. This further highlights the need for an assessment of compliance with Sprinkles in the region.
Methods Project Background and Context The Sprinkles pilot study was conducted in government-funded health facilities in three health districts in Alta Verapaz province: Tucurú, Tactic and Santa Cruz Verapaz. The health districts are named for the municipalities in which they are located. Within the health districts, ten health facilities distributed Sprinkles as a means to prevent anemia in children ages 6 to 59 months who live within their jurisdiction. Like the districts, the health facilities are named for the communities which they serve, and each community belongs to one of the three municipalities. The health facilities in each of the health districts consist of one main health center and two or three health posts, depending on the size of the population served by the district (see Table 2). All children attending the ten health facilities were eligible for participation in the study. Health personnel distributed 60 sachets of Sprinkles to the caregivers of the children upon enrollment. They then instructed caregivers on proper in-home administration of Sprinkles, in accordance with the information they received in a health worker training session given by stakeholders at the start of the project. A total of 8,050 children were enrolled in the project between September 2006 and December 2007.
16
Figure 2: Location of Health Districts Where the Sprinkles Pilot Study Was Conducted.
S Santa Cruz Verapaz Tactic
Tucurú
Source: http://www.captureguatemala.com/en/altaverapaz/candelaria_caves
Table 2: Health Facilities Participating in the Sprinkles Pilot Study.* Santa Cruz Verapaz 1.Santa Cruz (HC) 2. Chijou (HP) 3. Najquitob (HP)
Tactic 1. Tactic (HC) 2. Pasmolón (HP) 3. Chacalté (HP) 4. Chiacal (HP)
Tucurú 1. Tucurú (HC) 2. Cucanjá (HP) 3. Raxquix (HP)
*HC= Health Center, HP= Health Post.
17
Study Site and Population This study took place in each of the ten communities within the three health districts in Alta Verapaz province listed in Table 2. The target population was the caregivers of the children 6-59 months of age who were enrolled in the pilot project at each of the ten participating health centers and posts. Only caregivers who were enrolled during the first three months that the project was in operation (February through April 2007) were included in the study.
Sample Size Calculation and Sampling Methodology 347 caregivers were randomly selected from the registries of each of the ten participating health facilities. This sample size was feasible to attain within the context of the study. It was calculated in Epi Info and a 10 percent adjustment for non-response was added. The number of children who received Sprinkles during the first three months of enrollment in the project was used as the sample size. Because expected compliance in this population is unknown, a prevalence of 50 percent was used in this calculation. Table 3 gives a step-by-step description of how the sample size was reached. Table 3: Sample Size Calculation and Adjustment for Non-Response. Population Size Alpha Prevalence Precision Epi Info Sample Size Non-Response Adjustment Final Sample Size
1,672* .05 50% Âą5pp (45% a 55%) 312 312/.90 347
*The number of children who received Sprinkles through the project in the months of February, March and April, according to the projectâ&#x20AC;&#x2122;s registries.
18
The number of participants surveyed in each municipality was determined by using proportionate stratified sampling. Out of 1,672 children that received Sprinkles between February and April 2007, 520 (31.1%) were enrolled in the pilot study in the health district of Tucurú, 822 (49.2%) in Tactic and 330 (19.7%) in Santa Cruz. These percentages were used to calculate the number of caregivers that would be interviewed in each of the three health districts. This resulted in 108 caregivers in Tucurú, 171 in Tactic, y 68 in Santa Cruz. By once again utilizing the project registries of the children who received Sprinkles between February and April 2007, the percentages of children who received the Sprinkles in each health facility (within the three health districts) were calculated (see Table 4).
Table 4: Proportion and Number of Caregivers Interviewed in Each Health Facility.* Service Tucurú (HC) Raxquix (HP) Cucanjá (HP) Tucurú Health District Total
Percent 52.1% 20.2% 27.6%
Number of Interviews 56 22 30
100%
108
Tactic (HC) Chacalté (HP) Pasmolón (HP) Chiacal (HP) Tactic Health District Total
61.3% 8.4% 21.8% 8.5%
105 14 37 14
100%
171
Santa Cruz (HC) Chijou (HP) Najquitob (HP) Santa Cruz Health District Total All Three Health Districts Total
26.7% 32.1% 41.2%
18 22 28
100%
68 347
*HC= Health Center, HP= Health Post.
19
Interviews Survey-based interviews were conducted with the caregivers in their homes. Many caretakers in Tactic and Santa Cruz Verapaz spoke only Poqomchi'; In TucurĂş nearly all spoke exclusively Q'eqchi'. For this reason, two translators were used, and they were trained for two days prior to conducting the interviews. These translators were recommended by local health staff who had used them on previous occasions. The survey was developed into Spanish and translated into the local language during the interviews. Caregivers were given the choice to interview in either the local language or in Spanish. Oral consent was obtained from each participant before the start of the interviews. Survey Instrument The survey contained 31 closed-ended questions and five open-ended questions. Prior to beginning the interviews, it was pilot-tested on twenty caretakers (5.8 percent of sample size) in Tactic who were not selected for inclusion in the study but still received Sprinkles for their children at the health center. Through a series of questions about the frequency of Sprinkles administration, the extent to which caregivers were complying in the home was assessed, as well as whether compliance differed depending on the health facility where the child was enrolled. Socioeconomic status (SES) was assessed through observation of the researcher upon entering the homes of the caretakers and six SES variables were recorded on the questionnaire. Questions about the specific instructions for administration received at the health facilities provided insight as to whether proper instructions were given in each health facility and whether they were clearly understood by the caregivers. These
20
questions were designed to assess whether the quality of the instructions received had an influence on compliance. Questions about the caregivers’ education level, Spanish ability and attitudes and practices regarding administration of the Sprinkles to the child were also included in the survey. Answers to these questions were used to determine the association between each of these variables and caregivers’ compliance. Finally, attitudes and opinions about the Sprinkles project and side effects of Sprinkles were assessed through a series of openended questions. This allowed caregivers to express any issues or feelings they had in their own words. The full questionnaire can be found in Appendix A. Data Analysis Data was analyzed using SAS software. Compliance was calculated by dividing the number of packets of Sprinkles consumed by the total number received (60). Compliance was compared between health districts as well as between health facilities using one-way Analysis of Variance (ANOVA). ANOVA was also used to determine differences in compliance between the time periods in which the caregivers were given to comply with administration of Sprinkles to their child (2-3 months, 3-4 months and 4-5 months). Socioeconomic status (SES) was determined by adding the values of each answer choice for all six questions about SES to come up with a total SES score for each caregiver. Group means and frequencies were calculated for SES, demographic variables, instructions received by caregivers, education level, communication ability and attitudes and practices regarding administration of the Sprinkles to the child. General linear models (GLM) with compliance as the outcome variable were used to determine whether any of these factors influence compliance. Finally, caregivers’ answers to open-ended
21
questions were categorized and given numeric values so that group means could be calculated. GLM was also used with these variables to determine whether attitudes, opinions or side effects influenced compliance.
Ethical Considerations This study was approved by the Emory University Internal Review Board (IRB). This study asked only for oral consent because there is a low literacy rate among this population and many caregivers would have been unable to provide a signature. Because only oral consent was used there was no linkage between the consent form and the data provided by each participant. All surveys were de-identified and no voice recordings or tapes were used during the interview or at any other time during the study.
Results Demographic Information The response rate in all health facilities was greater than 90%. Out of 347 caregivers, 325 were interviewed and 22 declined all or part of the interview, making the overall non-response rate 6.4%. The mean age of the caregiver in the three health districts was 29.0 years and the mean age of the child was 3.0. There were no differences in the caregiversâ&#x20AC;&#x2122; age (p-value= 0.0943) or childâ&#x20AC;&#x2122;s age (p-value= 0.1186) across health districts. Most caregivers were either married or living with their partner (91.5%), and the majority had either or no education (46.5%) or did not complete primary school (32.5%). Caregivers in Santa Cruz Verapaz were the most educated, as 27.4% completed primary school, however education did not differ significantly between health districts ( p-value= 0.3805).
22
Spanish ability varied by health district. Overall, 44.9% spoke Spanish ‘well’ or ‘very well’, 25.2% spoke Spanish ‘somewhat’ or ‘a little’ and 30.0 % spoke it ‘very little’ or ‘not at all’. However, when Spanish ability was considered by health district, about one half of caretakers in Tactic (54.8%) and Santa Cruz (50.0%) said they spoke Spanish ‘well’ or ‘very well,’ versus only 25.5% in Tucurú. There was a strong association between health district and Spanish ability (p-value= <.0001).
Table 5: Demographic Information of Caregivers Participating in the Sprinkles Pilot Study. Tactic
Santa Cruz
Tucurú
TOTAL
Mean Age (years) Caregiver Child
28.28 2.86
29.13 3.07
30.27 3.21
29.0 (28.54, 30.21) 3.01 (2.86, 3.16)
Marital Status (%) Married or LOP*
92.77
91.94
89.22
91.52
Education (%) None > None < Primary School ≥ Primary School
46.06 33.33 20.6
40.32 32.26 27.42
50.98 31.37 17.64
46.5 32.52 20.97
Spanish Ability (%) Very Well or Well Somewhat or A Little Very Little or Not At All
54.82 25.3 19.88
50.0 20.96 29.03
25.49 27.46 47.06
44.85 25.15 30.0
*LOP= Living with partner.
Socioeconomic Status (SES) Six variables were used to determine the SES of the caretaker: Type of roof, type of stove, type of toilet, type of walls, type of floor, and the number of rooms in the home. For each variable, a number value was assigned to each answer choice. The scale ranged from 8 to 26 points; the higher the number, the higher the socioeconomic status of the
23
caregiver. The SES scores in Tactic and Santa Cruz were 15.6 and 14.8, respectively. Tucurú had the lowest SES with a score of 12.4. One-way ANOVA and Tukey’s Test revealed that caregivers in Tucurú were statistically different from caregivers in the other two health districts with regard to SES (p=value=<.0001). Table 6 shows that SES from caregivers who were given the Sprinkles at health centers had higher SES scores than caregivers who received them from health posts. Table 6: Mean Socioeconomic Status (SES) of Caregivers in Each Health Facility and Health District.* Health Facility **Chiacal (HP) **Chacalté (HP) Pasmolón (HP) Tactic (HC)
Mean SES Score 14.50 13.69 14.36 16.41
95% C.I. (12.52, 16.48) (12.47, 14.91) (13.43, 15.29) (15.71, 17.11)
**Najquitob (HP) **Chijou (HP) **Sta. Cruz (HC)
13.48 14.0 18.88
(12.63, 14.34) (12.55, 15.45) (17.33, 20.42
**Raxquix (HP) Cucanjá (HP) Tucurú (HC)
11.05 12.71 12.75
(9.74, 12.35) (11.48, 13.95) (11.78, 13.72)
Tactic Health District Sta. Cruz Health District Tucurú Health District
15.62 14.79 12.37
(15.10, 16.14) (13.92, 15.65) (11.72, 13.03)
*HC = Health Center, HP = Health Post. **There were less than 30 respondents in these communities.
Compliance When asked about the frequency of use, 73.3 % of caregivers said they gave Sprinkles to their child everyday; 93.6% said they gave Sprinkles at least 2 to 3 times per week. Still, 74.2% reported that a week or more had passed since they last gave Sprinkles to the child. However, this may be confounded by the fact that many caregivers had already finished their 60 packets by the time the interview was conducted. Sharing was reported
24
only minimally (5.5%), however 44.8% of caregivers reported that their child failed to finish his/her food containing Sprinkles at least two times per week. Out of 60 packets given to the caregivers, the mean number consumed up to the time of the interview was 50.6 (49.0, 52.3), or 84.4% overall compliance. Compliance among caregivers in Tactic and Santa Cruz was similar; 47.5 (45.1, 50.0) packets were consumed in Tactic (79.2%), and 48.9 (41.3, 50.5) were consumed in Santa Cruz (76.5%). TucurĂş was statistically different from the other two health districts with regard to compliance (p-value=<.0001); it had much higher compliance (97.5%), and the average number consumed was 58.5 (57.4, 59.6) packets (see Figure 3). In Tactic and Santa Cruz, compliance varied by the health facility where the child received the Sprinkles; in TucurĂş all three health facilities had equally high levels of compliance (see Table 7).
Figure 3: Compliance among Caregivers Stratified by the Health District Where the Child Received Sprinkles.
Tactic
79.18%
Health District
Sta. Cruz
76.50% Tucuru
97.52% OVERALL
84.38% 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Compliance (%)
25
Table 7: Compliance among Caregivers Stratified by the Health Facility Where the Child Received Sprinkles.* Health Facility
Compliance (%)
**Chiacal (HP)
Mean # Packets Consumed 36.93
**Chacalté (HP) Pasmolón (HP) Tactic (HC)
48.77 46.78 49.72
81.28 77.96 82.86
**Najquitob (HP) **Chijou (HP) **Sta. Cruz (HC)
52.06 42.53 35.19
86.77 70.88 58.64
**Raxquix (HP) Cucanjá (HP) Tucurú (HC)
58.38 59.0 58.31
97.30 98.33 97.18
61.55
*HC = Health Center, HP = Health Post **There were less than 30 respondents in these communities.
Both Spanish level and SES were found to be influential factors with regard to compliance; Compliance was inversely related to Spanish ability (p-value=.0064), as well as to SES (p-value=<.0001). Education level, however, was not predictive of compliance (p-value=.0600). Nearly half of the caregivers had three to four months to administer the 60 packets of Sprinkles to the child before the interview took place (see Figure 4). Caregivers in Tactic had the shortest amount of time to comply (99.2 days), followed by Sta. Cruz (113.4) and finally Tucurú (132.3). The caregivers in each of the health districts were significantly different from each other with regard to the time for compliance (p-value=.0018). Time between the receipt of Sprinkles and the interview did not influence actual compliance (p=.0572).
26
Figure 4: Time Elapsed Between the Receipt of Sprinkles and the Interview among Caregivers.
Caregivers (%)
50% 42.63%
45% 40%
33.54%
35% 30%
23.83%
25% 20% 15% 10%
m on th s 5 to 4
to 3
2
to
3
4
m on th s
m on th s
5% 0%
Time to Comply
Correct Administration Most caregivers (98.1%) received instructions by health care personnel on proper administration of Sprinkles upon receipt of the 60-day supply. Whether or not instructions were received did not affect compliance (p-value=.4077). Instructions were well-understood by the caregivers; Over 97 percent reported adding Sprinkles to the childâ&#x20AC;&#x2122;s food after it had been cooked, adding Sprinkles directly to the childâ&#x20AC;&#x2122;s portion of food, and using the entire packet of Sprinkles. While only 49.2% said they were told that the child should not share food, this was irrelevant as sharing was minimal by children. However, 11.5% said that they were not instructed to give Sprinkles to the child everyday. Of these, only 21.6% gave Sprinkles everyday versus 77.7% among those who did receive instructions, indicating a strong association between frequency of administration and receipt of instruction to administer Sprinkles daily (p=value=<.0001). 27
Without taking into account the time that each caregiver had to comply, overall compliance was not affected by whether or not caregivers were told to administer Sprinkles everyday (p-value=.2586). Attitudes and Opinions about Sprinkles Most caregivers (76.9%) said that they thought Sprinkles was helping their child, however the proportion of caregivers in Tucurú (89.1%) was much greater than in Tactic and in Santa Cruz (71.3%, 71.7%), and this difference was statistically significant (pvalue= .0092). Additionally, caregivers who thought Sprinkles were helping the child had a mean overall compliance of 88.7%, versus caregivers who did not think it was helpful (47.8%). This difference was also significant (p=<.0001). The most common responses given by caregivers when asked why they think Sprinkles is important for their child were that Sprinkles prevents illness, that they make the child grow and that they make the child strong. Table 8 shows the full list of responses to this question. Fifteen caregivers (4.31%) stated that they did not think that Sprinkles was important for their child. These caregivers were from Tactic and Santa Cruz only; all caregivers in Tucurú thought Sprinkles were important for the child. Table 8: Caregivers’ Responses to Why Sprinkles are Important for the Child. Response Given
% Responded
Prevents illness
34.77
Makes child grow
27.87
Makes child strong
21.26
Increases child’s appetite
16.95
Makes child fat
11.21
28
When asked how easy/difficult it was to give Sprinkles to the child, 79.1% said that Sprinkles were ‘very easy’ or ‘somewhat easy’ to give to their child, while only 19.7% said it was ‘hard’ or ‘very hard’. Nearly all caregivers in Tucurú thought that Sprinkles were easy (95.1%), versus 75.0% and 73.3% in Tactic and Santa Cruz, respectively (pvalue=.0032). Additionally, compliance was affected by whether the caregiver thought Sprinkles was easy or hard to administer (p-value=<.0001). The majority of caregivers also said they would continue giving Sprinkles to their child if more packets were provided to them (85.2%), however once again, percentages varied by health district (pvalue=.0084) with Tucurú having the highest percentage (95.1%), followed by Tactic (81.7%) and Santa Cruz (78.0%). This variable was also associated with compliance (<.0001). When caregivers were asked whether they had any difficulties administering Sprinkles to their child, 61.5% said they had no difficulties, and this was an influential factor on compliance (p-value=<.0001). Table 9 lists the specific difficulties that caregivers had when administering Sprinkles to their children, and whether or not they stopped administration to the child as a result of those difficulties.
Table 9: Caregivers’ Reported Difficulties with Administration of Sprinkles. Difficulty with Sprinkles Mother forgets to add it to food Child doesn’t like the taste Food changed color Mother does not have correct type of food Caused diarrhea Child never finishes food with Sprinkles Caused vomiting
# Caregivers Reporting 61 55 39 28
# Who Stopped Giving Sprinkles unknown 32 28 12
24 16
10 11
9
9
29
Caregivers were also asked how they felt the Sprinkles project could be improved; 57.5% said they liked the project as-is, but 24.4% said that they would like syrup to be distributed instead of Sprinkles, with no differences across the health districts (pvalue=.0538). This was not predictive of compliance (p-value=.4096). Caregivers were also asked whether their child consumed any vitamins at the same time that Sprinkles was being given; among those giving iron or multivitamin syrup, sixteen caregivers said they liked the syrup better than Sprinkles. The main reason given was that the infant likes the sugary taste of the syrup, whereas Sprinkles has no taste. Summary The extent of compliance by caregivers differed by health district and health facility. The amount of time that the caregiver had between the receipt of Sprinkles and the interview and whether or not the caregivers received instructions on how to administer Sprinkles did not influence compliance. Spanish level and SES were found to be predictors of compliance, but education level was not. Attitudes and opinions about Sprinkles, such as whether or not caregivers believed Sprinkles was helping the child, and whether or not the caregivers had difficulties giving the Sprinkles to the child also affected compliance. TucurĂş differed in many ways from the other two health districts; Caregivers in TucurĂş had significantly higher compliance, and lower Spanish ability and SES. They were also more likely to have positive attitudes and opinions about the benefits of Sprinkles to the child and with regard to the ease of administration.
30
Discussion Findings Overall compliance by caregivers in Alta Verapaz was similar to the range found in previous studies. Considering the health districts, Tucurú’s high rate of compliance is equal only to that found among caregivers in Bangladesh who were given 4 months to comply with a 60-day supply of Sprinkles (Ip et al., 2007). Tucurú also had the longest amount of time to comply out of the three health districts (about 4 ½ months). Still, the influence that time to comply with Sprinkles administration had on actual compliance was slightly above the .05 significance level. More studies are needed to determine whether the time given for administration of Sprinkles leads to higher compliance. Tucurú was found to be very different with regard to the other communities, not only in terms of compliance level, but in terms of the factors that were found to influence compliance; SES, Spanish level were consistently were found to be highly significant predictors of compliance, and Tucurú had significantly lower SES and Spanish level as well. Variables regarding attitudes and opinions of Sprinkles were also significantly higher in Tucurú, and they also ended up to be predictors of compliance. Tucurú is very different than the other two districts in other ways as well; it is the only Q'eqchi'speaking community of the three, and it is much more rural—2 hours down a dirt road from the main highway—while Tactic and Santa Cruz are more densely populated and on the main route. It is possible, then, that the differences in compliance and the influential factors of compliance have more to do with the population itself and its location. For example, because it is so rural and is much poorer than the other communities, residents in Tucurú do not have as much access to government and NGO-sponsored programs; The
31
level of excitement in the district may have influenced their compliance, and how they feel about the Sprinkles pilot study. Caregivers in Alta Verapaz stated that one of the reasons that Sprinkles is important for the child is that it increases the childâ&#x20AC;&#x2122;s appetite. These were also noted changes reported by caregivers after Sprinkles were administered in Bangladesh (Ip et al., 2007), however caregivers there also noticed positive changes in behavior, which was not mentioned by caregivers in Alta Verapaz. Most Bangladeshi caregivers also reported that they found Sprinkles easy to use, as did caregivers in Alta Verapaz (Ziauddin Hyder et al., 2004). Prior studies on Sprinkles have reported that the majority of caregivers used the entire contents of Sprinkles each time they were added to the childâ&#x20AC;&#x2122;s food. This was consistent with findings in Alta Verapaz. However in Haiti (Menon et al., 2007), Bangladesh (Ip et al., 2007) and in one of the Ghanaian studies (S. Zlotkin et al., 2003), it was reported that the child consumed all of the food containing Sprinkles; in Alta Verapaz, health workers at the health facilities have been telling the caregivers to add Sprinkles only to a small portion of food first (one to two tablespoons), and then serve the child the rest of his/her food to ensure that the child get the complete dosage. This message did not stick, as caregivers were still reporting that the children werenâ&#x20AC;&#x2122;t getting the full dose of Sprinkles on a regular basis. Food sharing, however, was not an issue in Alta Verapaz or in the previous literature. As with most previous studies, side effects associated with Sprinkles in Alta Verapaz were minimal. Diarrhea and vomiting were reported by some, however none of the caregivers mentioned tooth-staining or stool darkening, contrary to the findings in previous literature. Discontinuation of Sprinkles administration due to illness was also
32
discussed in literature; in India and Ghana, caretakers ceased administration of Sprinkles if the child fell sick (Hirve et al., 2007). Around 40 percent of caregivers who reported diarrhea or vomiting in Alta Verapaz stopped giving Sprinkles to the child. Caregivers in Ghana also mentioned problems with forgetting to add Sprinkles to the food and the child disliking the taste of Sprinkles (Adu-Afarwuah et al., 2007). This was also the case in Alta Verapaz. Some caregivers also reported changes in the taste and color of the food when Sprinkles were added; This is consistent with the literature, as two of the Ghanaian studies reported similar alterations (S. Zlotkin et al., 2003; S. H. Zlotkin et al., 2003). While the number of caregivers in Alta Verapaz reporting changes in taste/ color was small, one reason for this could be that the Sprinkles used in this study were not the original SprinklesTM brand, but rather a low-cost alternative made in India. The iron in the Sprinkles from India is not microencapsulated as it is in the Sprinkles used in previous studies, which could account for some of the alteration in taste and color. Still, the fact that so few caregivers reported these alterations should be considered in future studies; the difference in taste/color between microencapsulated and non-microencapsulated iron in Sprinkles may be minimal and the benefits of the lower cost option may outweigh those of the SprinklesTM brand. The fact that about a quarter of caregivers in Alta Verapaz stated that they would like syrup to replace the Sprinkles and that the children prefer syrup because of its sugary taste is contrary to the literature; in fact, Sprinkles was invented as a replacement for syrups and other iron forms. While this study and previous studies have proven high compliance with Sprinkles, there may be some benefit to pilot-testing a supplement with
33
an added sweetener, though in so-doing, one would have to consider the possibility of iron overload in young children. Limitations Due to time constraints in the field, pilot tests were only conducted with twenty caretakers. All pilot testing was conducted in Tactic in the Poqomchi' language. This resulted in some setbacks in TucurĂş, because caregivers there were Q'eqchi' speakers, and, while the researcher also trained the translator in TucurĂş, the caregivers understood some of the questions differently than those in Tactic and Santa Cruz Verapaz. A trilingual health worker (Spanish- Q'eqchi'- Poqomchi') determined that the translator could use alternative phrases in the Q'eqchi' language without altering or changing the meaning of the questions. In the ChacaltĂŠ community, many of the caretakers who were randomly selected for the interviews spoke Achi', and did not understand the Poqomchi' language. This was unforeseen, as even the health personnel at the provincial level were unaware of the difference in language there. A local community leader helped to translate, however he was only briefly trained. Additionally, the fact that he was male may have also affected the results from the caretakers, because female translators were used in the other two communities. In terms of sample size, the samples from the health facilities were small; as a result, analysis at this level resulted in larger variation and less power to detect differences between the health facilities. However, stratification at this level still allowed for inferences to be made in terms of these differences, and they were therefore still included in the analysis.
34
The variables used to determine SES were based from a previous study that the researcher conducted in Nahualá, Guatemala (Sinclair, 2007). While they were a good measure of SES in Nahualá, some of the variables used were not as effective in Alta Verapaz. For example, while “type of stove used” produced varied responses in Nahualá, most caretakers in Alta Verapaz cooked with the same type of stove (open-flame, woodburning). Still, the scale was successful in demonstrating differences in SES between the health districts, and also in recognizing SES as a predictor of compliance. Finally, the date that the caregivers received the Sprinkles was recorded on the child’s immunization card, but not the date that caregivers finished the 60 packets of Sprinkles. This means that the amount of time each caregiver had to comply with administration of Sprinkles to the child could not be calculated. Instead the researcher measured how many months had passed from the time the Sprinkles were received to the time of the interview, in order to infer whether compliance varied according to the time frame in which the caretaker complied. Recommendations and Conclusion The findings of this study indicate that compliance among caregivers was high in all three health districts. The majority of caregivers recognized that Sprinkles is important for the child, and caregivers experienced only minimal difficulties with Sprinkles administration. Additionally, caregivers were clearly able to understand the instructions given at the health facilities. Compliance was found to be highest among a rural community with low SES; much of Guatemala fits this criterion, and these areas are usually those most in-need of a nutrition intervention. This means that Sprinkles is an appropriate intervention for Guatemala. Based in the results of this study, the recommendation is to implement
35
distribution of Sprinkles through the government-funded health facilities nationally, with special attention focused on lower income and rural populations.
36
Appendix A: Guatemala Sprinkles Compliance Survey.
37
Date of Interview__ __ / __ __ / __ __ D D M M Y Y GUATEMALA SPRINKLES COMPLIANCE SURVEY COVER SHEET Part I
Questionnaire number: __ __ __ Subject number:
__ __ __
Municipality number: __ __
Part II Number of visits 1
2
3
__ __ / __ __ / __ __ D D M M Y Y
__ __ / __ __ / __ __ D D M M Y Y
__ __ / __ __ / __ __ D D M M Y Y
Duration of Interview (minutes):
__ __ __
__ __ __
__ __ __
Result*:
_______
_______
_______
Visits by interviewer:
*Result codes: 1. Completed interview 2. Caregiver not home at time of visit; revisit necessary 3. Total refusal 4. Refusal during the interview (by person or other family member) 5. Respondent not competent 6. Other (specify)________________________________________
38
Date of Interview__ __ / __ __ / __ __ D D M M Y Y GUATEMALA SPRINKLES COMPLIANCE SURVEY
SOCIO-ECONOMIC ASSESSMENT Interviewer to fill out the following housing conditions. Based on observation only. H1. Roof material:
H4. Type of stove:
1_____tile
1_____gas
2_____corrugated metal/plastic
2_____wood-burning (with chimney)
3_____straw
3_____wood-burning (open flame)
4 Other (specify):________________
4 Other (specify):_________________
H2. Wall material:
H5. Type of toilet:
1_____cinder block
1_____flushing toilet
2_____adobe
2_____outhouse
3_____wood
3_____no toilet
4_____corrugated metal
4 Other (specify):__________________
5_____cane 6 Other (specify):________________
H3. Floor material:
H6. Number of visible rooms: _____
1_____tile 2_____cement 3_____wood 4_____dirt 5 Other (specify):_________________
39
Date of Interview__ __ / __ __ / __ __ D D M M Y Y INTRODUCTION My name is Bronwyn Mariella Sinclair and I am a student at Emory University. I am conducting a survey about Sprinkles usage in the home. I would like to ask you several questions about yourself, your child and your participation in the Sprinkles project. This information will help us improve the project for future participants. The interview will last approximately 30 minutes. All responses will be confidential; your name will not be connected to your answers. Participation in this interview is voluntary and you can choose not to answer any or all of the questions I ask you. However, we hope that you will participate because your views are important to us.
Time interview begins:_ _: _ _ Time interview ends: _ _ : _ _
Please answer each question to the best of your ability.
Q1. What is the day, month and year of your birth? __/__/____ DD MM YYYY
Q2. What is your marital status? 1_____Never Married/Never lived with a partner 2_____Married/Living with partner 3_____Divorced/Separated 4_____Widowed
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y Q3. What is your highest level of education? 1_____No education 2_____Completed primary 3_____Completed middle school 4_____Completed high school 6 Other (specify)____________________________________________________
Q4. How well do you understand Spanish? 1_____Very well 2_____Well 3_____Somewhat 4_____A little 5_____Very little 6_____Not at all
Now we are going to ask you about you and your childâ&#x20AC;&#x2122;s participation in the Sprinkles project.
Q5. What is the day, month, and year of birth of the child who is receiving the Sprinkles? __/__/____ DD MM YYYY
Q6. On what date was your child enrolled in the Sprinkles project? __/__/____ DD MM YYYY
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y
Q7. At which health facility was your child enrolled in the Sprinkles project? _____________________
Q8. How often do you usually give the Sprinkles to your child? 1_____Once per day 2_____Every other day 3_____2-3 times per week 4_____At least once per week 5_____At least twice a month 6_____At least once a month 7_____Less than once per month
Q9. When was the last time you gave your child Sprinkles? 1_____Today 2_____Yesterday 3_____Two days ago or more 4_____One week ago or more 5_____Two weeks ago or more 6_____One month ago or more 7 Other (specify)____________________________________________________
Q10. Out of the 60 packets of Sprinkles that you were given at the health facility, how many do you have left? Help respondent count the number of packets. ___ ___
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y
Q11. Can you show me an empty packet of Sprinkles that you have recently used? Ask respondent to show you an empty packet of Sprinkles. Check YES if you see it, NO if you do not. 1_____Yes 0_____No
Q12. Has your child ever shared his/her portion of food that contains Sprinkles with anyone else? 1_____Yes 0_____Never Go to Q14
Q13. How often does your child share his/her portion of food that contains Sprinkles with at least one other person? 1_____Everyday 2_____Every other day 3_____At least once per week 4_____Less than once per week
Q14. How often does your child fail to finish his/her portion of food that contains Sprinkles? 1_____Everyday 2_____Every other day 3_____2-3 times per week 4_____At least once per week 5_____Less than once per week
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y Q15. Do you add Sprinkles to the child’s portion of food before, during or after cooking? 1_____After 0_____Before or during
Q16. Do you add Sprinkles directly to a portion of the child’s food? 1_____Yes 0_____No
Q17. When you add Sprinkles to a portion of your child’s food, do you usually add one full packet, just part of the packet, or more than one packet to your child’s food? 1_____One full packet 2_____Part of the packet 3_____More than one packet 4_____Don’t know
Q18. Did you receive instructions at the health facility about how to give Sprinkles to your child? 1_____Yes 0_____No Go to Q21
Q19. Who gave these instructions? 1_____Doctor 2_____Nurse 3_____Health worker 4_____Project facilitator 5 Other (specify)____________________________________________________
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y Q20. Did he/she tell you… a. To add Sprinkles to the child’s food after it has been cooked? 1_____Yes 0_____No
b. To add Sprinkles only to a portion of food that is consumed by the child? 1_____Yes 0_____No
c. That the child should not share his/her portion of food with Sprinkles added with anyone else? 1_____Yes 0_____No
d. To give Sprinkles to your child every day or every other day? 1_____Yes 0_____No
Q21. Do you believe that Sprinkles is helping your child? 1_____Yes 0_____No 9_____Don’t know
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y
Q22. Would you say that Sprinkles is… 1_____Very easy to give to your child 2_____Somewhat easy to give to your child 3_____In between/Not easy or hard 4_____Somewhat hard to give to your child 5_____Very hard to give to your child 9_____Don’t know
Q23. Would you continue giving Sprinkles to your child if more packets were made available to you? 1_____Yes 2_____No 9_____Don’t know
Q24. Are you currently giving any other vitamins to your child besides Sprinkles? 1_____Yes 2_____No Go to Q28
Q25. What kinds of vitamins are they? If respondent doesn’t know, ask her to show you the vitamins. __________________________________________________________________
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y
Q26. Do you like Sprinkles more than the other vitamins you are giving to your child, less than the other vitamins, or the same as the other vitamins? 1_____More 2_____The same 3_____ Less 9_____Donâ&#x20AC;&#x2122;t know
Q27. Has your child had diarrhea or pneumonia during the past two weeks? 1_____Yes 0_____No Go to Q30
Q28. Was your child prescribed zinc tablets at a government health center as part of his/her treatment? 1_____Yes 0_____No Go to Q30
Q29. Did you complete the zinc treatment indicated to you by the health personnel? 1_____Yes 0_____No
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y Now I am going to ask you some questions which you may answer in your own words.
Q30. Please explain why do you like Sprinkles more/less/the same as the other vitamins. See answer from Q26. _________________________________________________________________ __________________________________________________________________ __________________________________________________________________ Q31. Please explain any difficulties that you have had when giving Sprinkles to your child. __________________________________________________________________ __________________________________________________________________ __________________________________________________________________
Q32. Please explain whether you think it is important to give Sprinkles to your child and why. __________________________________________________________________ __________________________________________________________________ __________________________________________________________________ Q33. How were you treated by health care staff when your child was enrolled in the project? Please explain. __________________________________________________________________ __________________________________________________________________ __________________________________________________________________
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Date of Interview__ __ / __ __ / __ __ D D M M Y Y Q34. How do you think the Sprinkles project could be improved? Please explain. __________________________________________________________________ __________________________________________________________________ __________________________________________________________________
Q35. Is there anything else you would like to tell me about Sprinkles or about the Sprinkles project? __________________________________________________________________ __________________________________________________________________ __________________________________________________________________
Thank you for your time. Do you have any questions?
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Zlotkin, S. H., Schauer, C., Owusu Agyei, S., Wolfson, J., Tondeur, M. C., Asante, K. P., et al. (2006). Demonstrating zinc and iron bioavailability from intrinsically labeled microencapsulated ferrous fumarate and zinc gluconate Sprinkles in young children. Journal of Nutrition, 136(4), 920-925.
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