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Food and Agricultural Approaches to Reducing Malnutrition

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02505711
Acronym
FAARM
Enrollment
2705
Registered
2015-07-22
Start date
2015-03-14
Completion date
2021-08-30
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Agriculture, Food, Micronutrients, Pregnancy, Infants, Women's groups, Bangladesh

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.

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.

Interventions

BEHAVIORALHomestead 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).

Sponsors

Helen Keller International
CollaboratorOTHER
BRAC University
CollaboratorOTHER
University of Giessen
CollaboratorOTHER
German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
Department for International Development, United Kingdom
CollaboratorOTHER_GOV
International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
German Research Foundation
CollaboratorOTHER
Sabine Gabrysch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 30 Years
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) 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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Intrauterine growth retardation: lengthMeasured within 3 days of birth, 15-57 months after randomizationLength-for-gestational-age
Intrauterine growth retardation: small-for-gestational ageMeasured within 3 days of birth, 15-57 months after randomizationWeight-for-gestational-age adjusted for time since birth
Intrauterine growth retardation: head sizeMeasured within 3 days of birth, 15-57 months after randomizationHead circumference-for-gestational-age
Wasting in children below 3 years of ageMeasured 50 months after randomizationWeight-for-length/height Z-score
Head circumference in children below 3 years of ageMeasured 50 months after randomizationHead circumference-for-age Z-score
Underweight in womenMeasured 50 months after randomizationBody Mass Index (BMI, non-pregnant women), mid-upper-arm circumference (MUAC, pregnant women)
Gestational weight gainMeasured every 2 months during pregnancy, 6-57 months after randomizationGestational weight gain Z-score
Anemia in women and children below 3 years of ageMeasured 50 months after randomizationHemoglobin concentration
Micronutrients: Vitamin A deficiency in women and in children below 3 years of ageMeasured 50 months after randomizationRetinol-binding protein, corrected for inflammation (CRP, AGP)
Linear growth in children aged 6-30 monthsMeasured 50 months after randomizationLength/height-for-age Z-score
Micronutrients: Zinc deficiency in women and in children below 3 years of ageMeasured 50 months after randomizationSerum zinc, corrected for inflammation (CRP, AGP)
Early child development (adapted WHO milestones)Measured at appropriate ages for milestones, 6-50 months after randomizationGross and fine motor, cognitive, personal-social and communication skills
Diarrhea in children below 3 years of ageMeasured every 2 months, 6-50 months after randomizationPeriod and point prevalence of diarrhea
Acute respiratory infection in children below 3 years of ageMeasured every 2 months, 6-50 months after randomizationPeriod prevalence of acute respiratory infection
Enteropathy in children below 18 months of ageMeasured 36 and 50 months after randomizationBiomarkers: 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 ageMeasured every 2 months, 6-50 months after randomizationMean probability of adequate micronutrient intake (MPA)
Dietary diversity in women and children below 3 years of ageMeasured every 2 months, 6-50 months after randomizationIndividual dietary diversity score, breastfeeding behaviors
Fecal contamination of complementary food for children 6-18 months of ageMeasured 36 months after randomizationLog-transformed counts of total coliforms and E. coli in complementary food samples
Food hygiene behaviour in mothers of children aged 6-18 monthsMeasured 36 months after randomizationHygiene score from structured observation of mothers
Micronutrients: Iron deficiency in women and in children below 3 years of ageMeasured 50 months after randomizationFerritin and soluble transferrin receptor, corrected for inflammation (CRP, AGP)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026