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Trial Status
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in_development
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completed
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Abstract
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Before
Young children in the developing world often maintain an unhealthy diet with very low dietary diversity, which increases the risk of not only stunting and wasting but also chronic diseases. This research project aims to identify the major barriers to improved complementary feeding and ways to address them in a developing country setting. Formative research suggests information, affordability, accessibility, gender, and peers to be the major constraints. Under this hypothesis, the study will employ clustered randomized experiment in the context of Ethiopia to examine the effects of nutrition behavior change communication (BCC), food vouchers, food accessibility, gender education, and peers on child feeding behaviors and child growth.
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After
Young children in the developing world often maintain an unhealthy diet with very low dietary diversity, which increases the risk of not only stunting and wasting but also chronic diseases. This research project aims to identify the major barriers to improved complementary feeding and ways to address them in a developing country setting. Formative research suggests information, affordability, accessibility, gender, and peers to be the major constraints. Under this hypothesis, the study will employ clustered randomized experiment in the context of Ethiopia to examine the effects of nutrition behavior change communication (BCC), food vouchers, gender education, and peers on child feeding behaviors and child growth.
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Last Published
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December 05, 2017 10:42 AM
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After
April 22, 2021 05:03 AM
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Study Withdrawn
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No
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Intervention Completion Date
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Before
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June 30, 2018
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Data Collection Complete
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After
Yes
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Final Sample Size: Number of Clusters (Unit of Randomization)
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Before
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105 villages
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Was attrition correlated with treatment status?
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No
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Final Sample Size: Total Number of Observations
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875 women-men-child group
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Final Sample Size (or Number of Clusters) by Treatment Arms
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Before
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After
11-15 villages in 'each' treatment arm
37 villages for the control group
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Data Collection Completion Date
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December 30, 2019
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Intervention (Public)
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Before
There is a total of six intervention arms including control: 1) BCC for mothers, 2) BCC for mothers and fathers, 3) food vouchers, 4) BCC for mothers and food vouchers, 5) BCC for mothers and fathers and food vouchers, and 6) control. The duration of intervention is six months, but individuals will be followed up to 12 months to see whether the child-feeding habits continue to stay with the households. All interventions have been pilot tested in the project site to refine the BCC materials and voucher procedures, and to assess the feasibility and acceptability of the interventions. All interventions will be conducted and funded by AFF.
1. Mother BCC
A behavior change communication (BCC) intervention on complementary feeding practice for mothers has been developed based on the Alive and Thrive’s BCC program materials that have been successfully implemented in Ethiopia. BCC will be delivered in groups of six through weekly sessions for a duration of 6 months. Key gaps in knowledge and barriers identified through formative studies are also addressed in the BCC modules.
We also conduct individually-tailored trainings based on participant’s food recall survey results, youngest child’s age, and child caring behavior. The training informs the participants what to eat (local sources of protein and vitamins A and C), what not to eat (e.g., excessive oil, sugar, and processed food), how much and when to eat (e.g., ideal eating frequency by age groups, when to introduce solid food for infants, when to introduce non-breastmilk liquid for infants, etc.), ideal intra-household allocation of food, and short and long-term benefits of good nutrition. Counseling will consist of comparing the household's nutrition level in terms of micro and macronutrients with the ideal standard, and helping the mothers to set monthly concrete goals. Mothers are also encouraged to keep a food log for self-monitoring. Training, counseling, and food recording is aided by highly image-oriented pictures and brochures. The training and counseling materials will follow, as appropriate, WHO and UNICEF guidelines on child growth and development.
2. Father BCC
A BCC intervention on complementary feeding practice for fathers has been developed based on the Alive and Thrive’s resources. Materials to raise awareness on gender related constraints between spouses will be adapted from Nurturing Connections developed by Helen Keller International and USAID’s infant and young child nutrition project targeting male group. Key gaps in knowledge and barriers identified through formative studies will be addressed in the BCC modules.
As the gender-related modules from Helen Keller International and USAID have not been tested for acceptability in Ethiopia, we tested the developed modules through multiple father focus group interviews and modified the contents reflecting the comments from the fathers.
Materials will be delivered in groups of six through weekly sessions for the duration of three months. As most fathers are orthodox farmers who do not work during orthodox holidays (about seven days a month), BCC training will be conducted during orthodox holidays or seven to eight am in the morning before work begins. This schedule was found to be the most convenient time from the formative study of fathers. Motivational interview technique will be used to individually counsel the fathers.
3. Food vouchers
Food vouchers are transferred monthly at the Project Office in Holeta. Eligible participants will receive approximately 15% of their monthly income, 200 ETB, estimated around US$10. Transferors will verbally state that the purpose of the vouchers is to enable households to consume healthier food and that they are nontransferable, while making clear that nothing is required of them to receive the voucher and that no rule or regulation is tied to the receipt of the transfers. Food vouchers will be distributed monthly to mothers at Holeta Project Office, and they will be given in denominations of 20 ETB to facilitate small transactions. At the first disbursement, careful instructions will be provided as to how to use the vouchers. Each voucher will have a blue-colored official stamp to prevent fake vouchers and a household identification number to be matched with household IDs to prevent transfers.
Vouchers will be redeemable for a broad list of food groups including cereals, tubers, fruits, vegetables, legumes, meats, fish, milk products, and eggs. Vouchers can be used at selected shops and regular markets in which voucher stands will be available for sellers to cash out the vouchers. Shops or sellers will be required to match the vouchers with the household IDs and to keep a record of the food items that they bought and their monetary amount. Vouchers can be used over a series of visits per month and must be redeemed within the month it was received.
4. Access to healthy food
For a random half of the treated and control groups, we will send petty traders with diverse food items to their localities to increase accessibility. This is taking into consideration that some mothers, especially rural residents, have access a limited set of food items in the markets that they usually visit, lacking dairy products, meat, green leafy vegetables, and diverse fruits. To bridge this accessibility gap, we will send petty traders to some selected markets with dairy products, meat, and various fruits and vegetables.
5. Price variation of healthy foods
We will introduce variation in the prices of healthy foods that are sold through petty traders to estimate the impact of price on demand. Price variations will take the form of 10%, 20%, or 30% discounts. While price will be varied by each petty trader every time, average food prices over the 6-month intervention period will be the same among all petty traders.
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After
There is a total of six intervention arms including control: 1) BCC for mothers, 2) BCC for mothers and fathers, 3) food vouchers, 4) BCC for mothers and food vouchers, 5) BCC for mothers and fathers and food vouchers, and 6) control. The duration of intervention is six months, but individuals will be followed up to 12 months to see whether the child-feeding habits continue to stay with the households. All interventions have been pilot tested in the project site to refine the BCC materials and voucher procedures, and to assess the feasibility and acceptability of the interventions. All interventions will be conducted and funded by AFF.
1. Mother BCC
A behavior change communication (BCC) intervention on complementary feeding practice for mothers has been developed based on the Alive and Thrive’s BCC program materials that have been successfully implemented in Ethiopia. BCC will be delivered in groups of six through weekly sessions for a duration of 6 months. Key gaps in knowledge and barriers identified through formative studies are also addressed in the BCC modules.
We also conduct individually-tailored trainings based on participant’s food recall survey results, youngest child’s age, and child caring behavior. The training informs the participants what to eat (local sources of protein and vitamins A and C), what not to eat (e.g., excessive oil, sugar, and processed food), how much and when to eat (e.g., ideal eating frequency by age groups, when to introduce solid food for infants, when to introduce non-breastmilk liquid for infants, etc.), ideal intra-household allocation of food, and short and long-term benefits of good nutrition. Counseling will consist of comparing the household's nutrition level in terms of micro and macronutrients with the ideal standard, and helping the mothers to set monthly concrete goals. Mothers are also encouraged to keep a food log for self-monitoring. Training, counseling, and food recording is aided by highly image-oriented pictures and brochures. The training and counseling materials will follow, as appropriate, WHO and UNICEF guidelines on child growth and development.
2. Father BCC
A BCC intervention on complementary feeding practice for fathers has been developed based on the Alive and Thrive’s resources. Materials to raise awareness on gender related constraints between spouses will be adapted from Nurturing Connections developed by Helen Keller International and USAID’s infant and young child nutrition project targeting male group. Key gaps in knowledge and barriers identified through formative studies will be addressed in the BCC modules.
As the gender-related modules from Helen Keller International and USAID have not been tested for acceptability in Ethiopia, we tested the developed modules through multiple father focus group interviews and modified the contents reflecting the comments from the fathers.
Materials will be delivered in groups of six through weekly sessions for the duration of three months. As most fathers are orthodox farmers who do not work during orthodox holidays (about seven days a month), BCC training will be conducted during orthodox holidays or seven to eight am in the morning before work begins. This schedule was found to be the most convenient time from the formative study of fathers. Motivational interview technique will be used to individually counsel the fathers.
3. Food vouchers
Food vouchers are transferred monthly at the Project Office in Holeta. Eligible participants will receive approximately 15% of their monthly income, 200 ETB, estimated around US$10. Transferors will verbally state that the purpose of the vouchers is to enable households to consume healthier food and that they are nontransferable, while making clear that nothing is required of them to receive the voucher and that no rule or regulation is tied to the receipt of the transfers. Food vouchers will be distributed monthly to mothers at Holeta Project Office, and they will be given in denominations of 20 ETB to facilitate small transactions. At the first disbursement, careful instructions will be provided as to how to use the vouchers. Each voucher will have a blue-colored official stamp to prevent fake vouchers and a household identification number to be matched with household IDs to prevent transfers.
Vouchers will be redeemable for a broad list of food groups including cereals, tubers, fruits, vegetables, legumes, meats, fish, milk products, and eggs. Vouchers can be used at selected shops and regular markets in which voucher stands will be available for sellers to cash out the vouchers. Shops or sellers will be required to match the vouchers with the household IDs and to keep a record of the food items that they bought and their monetary amount. Vouchers can be used over a series of visits per month and must be redeemed within the month it was received.
Below are interventions that were considered, but not implemented
4. Access to healthy food
We originally planned to send petty traders with diverse food items to random half of the local market in the study area to assess the impact of accessibility to healthy food on feeding practices. This was taking into consideration that some mothers especially rural residents, have access to a limited set of food items in the market that they usually visit, lacking dairy, meat, vitamin A rich vegetables and fruits. However, we decided not to implement this intervention due to the political turmoil that was ongoing during the study period. Our original plan was to implement the study in 400 village. However, due to the political turmoil that was ongoing during the study period, we reduced the sample size to 105 villages of randomly selected 6 kebele (district). This resulted in limited number of local markets to implement the study.
5. Price variation of healthy foods
We planned to introduce variation in the prices of healthy foods that are sold through petty traders to estimate the impact of price on demand. This intervention was not implemented due to the political turmoil that was ongoing during the study period. We were worried that price manipulation may cause possible conflicts, risks, or misunderstanding about the NGO’s activities in the field, especially given the political and civil unrest.
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Primary Outcomes (End Points)
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Before
o Among Mothers:
Nutritional knowledge, attitudes, and practices related to infant and young child feeding
Measures of maternal capabilities
Household food and non-food consumption patterns
Food security measures
Household agricultural and livestock production patterns
24-hour recall for mother and children (per capita calorie intake, dietary diversity score, and food consumption score)
o Among Fathers:
Nutritional knowledge, attitudes, and practices related to infant and young child feeding
Perceived intrahousehold decision
Knowledge, attitude, and practices related to gender equality and childcare
o Among Children of Participating Mothers:
24-hour recall (per capita calorie intake, food frequency, dietary diversity score, and food consumption score)
Cognitive function: test scores
Hemoglobin test
Anthropometry
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After
• Primary Outcomes (end points)
1) Mother’s and Father’s nutritional knowledge
2) Child’s dietary diversity scores (CDDS)
3) Food consumption scores (FCS)
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Primary Outcomes (Explanation)
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Before
We will examine the interventions’ effects on a host of intermediary and long-term outcomes. The intermediary outcomes are nutritional knowledge and the acceptability of healthy food among mothers and children. To assess the quality of the diet, we will pay closer attention to the quantity and the share of healthy food (fruits and vegetables, and animal-sourced food) and of unhealthy food (sugar, sweets, snacks, processed food, oils, butter, other fats, etc.). This will be measured by per capita caloric intake, both total and by food groups, based on 24-hour recalls of mothers and children under two. Caloric intake is constructed by multiplying the food items consumed by the energy value for those items. Energy values are taken from the Nutrition Database for Standard Reference (USDA, 2010) and from Ethiopia Food Composition Table ([Source to be added]). Food consumption information will also be used to calculate the income elasticities of demand for various food items.
We will examine not only the quantity of food intake but also quality. The existing literature show that dietary diversity is a good proxy for healthy nutrition, including among children. Standard dietary diversity measures include the Household Dietary Diversity Score (HDDS) and the Child Dietary Diversity Score (CDDS). The HDDS sums the number of food groups consumed in the previous seven days from the following 12 groups (Kennedy et al., 2011): cereals, roots/tubers, vegetables, fruits, meat/poultry/offal, eggs, fish/seafood, pulses/legumes/nuts, milk/milk products, oils/fats, sugar/honey, miscellaneous. Similarly, CDDS sums the number of food groups consumed by the child in the past one day from the following seven groups: starchy staples, roots and white tubers, legumes/nuts/seeds, dairy products, meat and fish, eggs, vitamin A-rich foods, and other fruits and vegetables.
As for the long-term outcomes, we will pay special attention to child-feeding habits and health. We will examine eating patterns one month, two months, six months, and one year after the intervention to see if the healthy child-feeding habits “stick” with the mothers. We will also measure anthropometry (BMI, weight-for-height and height-for age z scores), and the incidence of infectious diseases to assess effects on chronic nutritional and health status.
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After
The primary outcomes of interest are mean difference in parents’ nutritional knowledge and child dietary diversity score (CDDS). Mother and fathers’ IYCF knowledge are assessed using a separate survey module that contains 34 and 27 questions, respectively, on topics such as importance of the first two years in child growth, appropriate feeding frequency and dietary diversity, and nutrient rich foods. We count number of questions correct and divide the number by total number of questions. To calculate CDDS, we use a survey module that contains questions on 40 food items or food groups that are consumed by children in the study area and age group. For each question, the interviewer asks the mother "Yesterday, during the day or night, did [NAME] eat [FOOD ITEM]?” If the answer is yes, the interviewer asks how many times the food item was fed to the child the previous day. The food items are grouped into seven food groups, and the CDDS is calculated by summing up the number of food groups the child consumed in the past 24 hours. The Food Consumption Score (FCS), a food security indicator, represents households' dietary diversity and nutrient intake. The FCS is calculated using the frequency of consumption of different food groups consumed by a household during the 7 days before the survey.
Details on primary and secondary outcomes were initially registered in pre-analysis plan
1) AEA trial registry: July 11, 2017
2) Clinicaltrials.gov: June 25, 2017
We are updating the AEA RCT registry to reflect the details written on the initial pre-analysis plan that was submitted to the AEA trial registry and clinicaltrials.gov.
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Experimental Design (Public)
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Before
o This study employs a community-based clustered randomized experimental design. To minimize potential contamination, control and treatment groups will be randomized at the village (garee) level. The study randomly assigns villages in Holeta and Ejere to one of the following six groups: BCC for mothers, BCC for mothers and fathers, vouchers, BCC for mothers and vouchers, BCC for mothers and fathers and vouchers, and control. For treatment groups receiving vouchers, participants will be individually randomized within the village such that half of the vouchers will be given to mothers and the other half will be given to fathers.
The experiment will be conducted in two phases. Mothers between the age of 18-40 years with children 4-20 months at baseline survey—June to September 2017—and her spouse or partner will be eligible for treatment and control in the first phase which will be conducted in 2017. Mothers between the age of 18-40 years with children 0-3 months and pregnant women at baseline will be surveyed for treatment and control in the second phase which will be conducted in 2018. Eligible households will be selected using the census data of Holeta and Ejere, which was collected during 2016. Approximately 400 villages in Holeta and Ejere will enter a lottery and will be randomly selected into one of the six groups. All eligible participants who provide consent to participate in the study will be assigned to the randomly selected group of the village that she resides in. Selected mothers and/or fathers living in the same village will form a group to receive BCC education or vouchers.
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After
This study is a community-based, clustered randomized controlled trial. The study was conducted in Ejere district located in the Oromia region of central Ethiopia, 52 km west of Addis Ababa. All villages in Ejere were eligible for clusters. We randomly selected three rural kebeles (equivalent to a ward) and all three urban kebeles within the Ejere district to include both urban and rural localities. Within the 6 selected kebeles, 105 garees (villages) were identified through Kebele leaders. We randomly assigned garees into treatment and control groups in a 1:3 (treatment: control) ratio: T1, maternal BCC only; T2, maternal BCC and paternal BCC; T3, food voucher only; T4, maternal BCC and food voucher; T5, maternal BCC, paternal BCC, and food voucher; and C, control. Randomization was stratified at the kebele level. Ownership of the food vouchers were individually randomized within the household between men and women. For female headed households, the women were given ownership of the food voucher.
The census data of 22,000 households living in Ejere district was collected during 2016 to identify eligible participants for the trial. For inclusion in this study, women had to be a resident of the study cluster, have children between 4-20 months, and consent to participate. Men were eligible if they lived with the participating women. Pregnant women or women who have children 0-3 months at the time of baseline was not eligible for the trial but was surveyed at baseline and follow-up to assess knowledge spillovers. The baseline survey was implemented from April to August 2017 before the start of the intervention, and the follow-up period was immediately after the completion of the BCC interventions (December 2017 to March 2018).
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Planned Number of Clusters
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Before
400 villages
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After
400 villages (planned)
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Planned Number of Observations
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Before
at least 2400 household (women-men-child pair)
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After
2400 household (women-men-child pair)
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Sample size (or number of clusters) by treatment arms
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Before
50 villages (300 households) for 'each' treatment arm
150 villages (900 households) for the control group
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After
50 villages in each treatment arm (planned)
150 villages for the control group (planned)
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Additional Keyword(s)
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Before
nutrition, behavioral change communication, food voucher, complementary feeding practices, affordability, accessibility, and gender
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After
nutrition, behavioral change communication, food voucher, complementary feeding practices, affordability, and gender
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Secondary Outcomes (End Points)
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Before
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After
Secondary outcomes
Child feeding frequency
Child’s height-for-age Z scores (HAZ), weight-for-height Z scores (WHZ) and Mid-upper arm circumference (MUAC)
Social support actions of father
Other outcomes
Household hygiene environment and practice
Minimum dietary diversity
Minimum meal frequency
Minimum acceptable diet
Intra-household decision making between the husband and wife
Household labor allocation
Communication between partners
Gender norm attitude
Perceived social support of mothers
Change in mothers’ weight circumference
Household food and non-food consumption patterns
Food security measures
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Secondary Outcomes (Explanation)
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Before
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After
Secondary outcomes of interests are child anthropometry. Child’s height, weight, and MUAC are collected three times in units of cm, kg, and cm, respectively. Height-for-age Z scores (HAZ), weight-for-height Z scores (WHZ), stunting, and wasting are calculated for analysis using the WHO child growth standards. Other measures of IYCF practices include minimum dietary diversity, minimum meal frequency, and minimum acceptable diet standards (WHO, 2010). Minimum meal frequency is the proportion of children who consumed minimum number of meals recommended for the age, and minimum dietary diversity is proportion of children who receive food from 4 or more food groups. Minimum acceptable diet is calculated by combining minimum dietary diversity and minimum feeding frequency adjusting for child’s age.
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