Food and Agricultural Approaches to Reducing Malnutrition

Study Overview
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Brief Summary
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The aim of this study is to evaluate the potential of reducing young child undernutrition in low-income countries through an integrated program that trains women's groups in agriculture, nutrition, child care and hygiene.

Detailed Description
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An estimated 165 million children worldwide suffer from chronic undernutrition which leads to compromised physical and cognitive development and prevents them from reaching their full potential. Nutrition-sensitive agricultural interventions that aim to increase dietary diversity, empower women and include an educational behaviour change component focused on nutrition and hygiene are a promising and sustainable approach to addressing undernutrition. However, evidence on the impact of such interventions is still scarce due to a lack of rigorous long-term evaluations. This study will test the hypothesis that integrated agriculture, nutrition and hygiene interventions can reduce undernutrition when children benefit in their crucial first 1000 days. The investigators will conduct an impact evaluation of Helen Keller International's Homestead Food Production program in Bangladesh that trains women's groups in vegetable and fruit gardening, poultry rearing, hygiene, child care and nutrition. Furthermore, the investigators will assess the program impact pathway to discern how any impact is achieved (through improved food production, income, food security, health service use, female empowerment, feeding and hygiene practices). The study design is a cluster-randomized controlled field trial in two sub-districts of Habiganj District, Sylhet Division, Bangladesh, including 2700 young women in 96 settlements. After the baseline survey in 2015, settlements will be randomized into 48 intervention and 48 control settlements. Women in the intervention settlements will receive training and support in Homestead Food Production during the following four years. A surveillance system will collect data on pregnancies, births, child development, nutrition and infections as well as pathway indicators. In 2019, the investigators will conduct the endline survey to assess the nutritional status of the 2700 women and their then approximately 1500 children below 3 years of age and compare between intervention and control.

Official Title
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Reducing Young Child Undernutrition Through an Integrated Agricultural Project With Women's Groups: A Cluster-randomized Trial in Rural Bangladesh

Conditions
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Malnutrition

Intervention / Treatment
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* Behavioral: Homestead Food Production program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For settlements: Located in selected unions of Habiganj District, Sylhet Division, North East Bangladesh Minimum distance to adjacent settlement at least 400 m Judged to be suitable for Homestead Food Production program by the NGO HKI Bangladesh (dry land year-round, at least 10 women eligible and interested) For women: Married and aged 30 years or less at enumeration Woman's husband stays overnight in household at least once a year Access to at least 1 decimal of land, ideally 0.25 decimal near the house For children: Biological child of a participant woman Aged 0-35 months at survey start or surveillance visit Exclusion Criteria: For women: Lack of interest in participating in a gardening program

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homestead Food Production<br>Enrolled in Homestead Food Production program from 2015 to 2019, 48 clusters, approx. 1350 women and 750 children | Behavioral: Homestead Food Production program<br>* Training and support for vegetable gardening and poultry rearing, and education on young child nutrition, hygiene and health topics, in women's groups, as designed by the international non-governmental organization (NGO) Helen Keller International (HKI).<br>* Other names: Nutrition education;|
| No Intervention: Control<br>(Health system strengthening in the study area), 48 clusters, approx. 1350 women and 750 children | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear growth in children below 3 years of age | Length/height-for-age Z-score | Measured 50 months after randomization (endline survey 2019) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear growth in children aged 6-30 months | Length/height-for-age Z-score | Measured 50 months after randomization | 
| Intrauterine growth retardation: length | Length-for-gestational-age | Measured within 3 days of birth, 15-57 months after randomization | 
| Intrauterine growth retardation: small-for-gestational age | Weight-for-gestational-age adjusted for time since birth | Measured within 3 days of birth, 15-57 months after randomization | 
| Intrauterine growth retardation: head size | Head circumference-for-gestational-age | Measured within 3 days of birth, 15-57 months after randomization | 
| Wasting in children below 3 years of age | Weight-for-length/height Z-score | Measured 50 months after randomization | 
| Head circumference in children below 3 years of age | Head circumference-for-age Z-score | Measured 50 months after randomization | 
| Underweight in women | Body Mass Index (BMI, non-pregnant women), mid-upper-arm circumference (MUAC, pregnant women) | Measured 50 months after randomization | 
| Gestational weight gain | Gestational weight gain Z-score | Measured every 2 months during pregnancy, 6-57 months after randomization | 
| Anemia in women and children below 3 years of age | Hemoglobin concentration | Measured 50 months after randomization | 
| Micronutrients: Vitamin A deficiency in women and in children below 3 years of age | Retinol-binding protein, corrected for inflammation (CRP, AGP) | Measured 50 months after randomization | 
| Micronutrients: Iron deficiency in women and in children below 3 years of age | Ferritin and soluble transferrin receptor, corrected for inflammation (CRP, AGP) | Measured 50 months after randomization | 
| Micronutrients: Zinc deficiency in women and in children below 3 years of age | Serum zinc, corrected for inflammation (CRP, AGP) | Measured 50 months after randomization | 
| Early child development (adapted WHO milestones) | Gross and fine motor, cognitive, personal-social and communication skills | Measured at appropriate ages for milestones, 6-50 months after randomization | 
| Diarrhea in children below 3 years of age | Period and point prevalence of diarrhea | Measured every 2 months, 6-50 months after randomization | 
| Acute respiratory infection in children below 3 years of age | Period prevalence of acute respiratory infection | Measured every 2 months, 6-50 months after randomization | 
| Enteropathy in children below 18 months of age | Biomarkers: faecal myeloperoxidase, faecal α1-antitrypsin, faecal neopterin, serum C-reactive protein, serum α-1-acid glycoprotein | Measured 36 and 50 months after randomization | 
| Dietary adequacy in women and children below 3 years of age | Mean probability of adequate micronutrient intake (MPA) | Measured every 2 months, 6-50 months after randomization | 
| Dietary diversity in women and children below 3 years of age | Individual dietary diversity score, breastfeeding behaviors | Measured every 2 months, 6-50 months after randomization | 
| Fecal contamination of complementary food for children 6-18 months of age | Log-transformed counts of total coliforms and E. coli in complementary food samples | Measured 36 months after randomization | 
| Food hygiene behaviour in mothers of children aged 6-18 months | Hygiene score from structured observation of mothers | Measured 36 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Agriculture, Food, Micronutrients, Pregnancy, Infants, Women's groups, Bangladesh