Food and Agricultural Approaches to Reducing Malnutrition (FAARM)

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Behavioral: Homestead Food Production program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2705
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Homestead Food Production; Enrolled in Homestead Food Production program from 2015 to 2019, 48 clusters, approx. 1350 women and 750 children	Behavioral: Homestead Food Production program; 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).; Other Names: Agriculture; Home gardening; Nutrition education
NO_INTERVENTION: Control; (Health system strengthening in the study area), 48 clusters, approx. 1350 women and 750 children

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sabine Gabrysch
• Collaborators: German Research Foundation; German Federal Ministry of Education and Research; Department for International Development, United Kingdom; International Centre for Diarrhoeal Disease Research, Bangladesh; Helen Keller International; University of Giessen; BRAC University
• Investigators: Principal Investigator: Sabine Gabrysch, MD MSc PhD, Heidelberg University

Publications and helpful links

General Publications

• Dupuis S, Hennink M, Wendt AS, Waid JL, Kalam MA, Gabrysch S, Sinharoy SS. Women's empowerment through homestead food production in rural Bangladesh. BMC Public Health. 2022 Jan 19;22(1):134. doi: 10.1186/s12889-022-12524-2.
• Wendt AS, Waid JL, Gabrysch S. Dietary Factors Moderate the Relation between Groundwater Iron and Anemia in Women and Children in Rural Bangladesh. Curr Dev Nutr. 2019 Aug 6;3(10):nzz093. doi: 10.1093/cdn/nzz093. eCollection 2019 Oct.
• Wendt AS, Sparling TM, Waid JL, Mueller AA, Gabrysch S. Food and Agricultural Approaches to Reducing Malnutrition (FAARM): protocol for a cluster-randomised controlled trial to evaluate the impact of a Homestead Food Production programme on undernutrition in rural Bangladesh. BMJ Open. 2019 Jul 4;9(7):e031037. doi: 10.1136/bmjopen-2019-031037.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2015
• Primary Completion (ACTUAL): February 15, 2020
• Study Completion (ACTUAL): August 30, 2021

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (ESTIMATE): July 22, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Micronutrients; Pregnancy; Infants; Bangladesh; Agriculture; Food; Women's groups
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 01ER1201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No