FAARM: Food and Agricultural Approaches to Reducing Malnutrition

Sponsor

Sabine Gabrysch (Other)

Overall Status

Completed

CT.gov ID

NCT02505711

Collaborator

Helen Keller International (Other), BRAC University (Other), University of Giessen (Other), German Federal Ministry of Education and Research (Other), Department for International Development, United Kingdom (Other), International Centre for Diarrhoeal Disease Research, Bangladesh (Other), German Research Foundation (Other)

2,705

Enrollment

Arms

77.6

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition	Behavioral: Homestead Food Production program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2705 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 14, 2015

Actual Primary Completion Date :

Feb 15, 2020

Actual Study Completion Date :

Aug 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Linear growth in children below 3 years of age [Measured 50 months after randomization (endline survey 2019)]
Length/height-for-age Z-score

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)