NCT02505711

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,705

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

4.9 years

First QC Date

July 17, 2015

Last Update Submit

May 17, 2022

Conditions

Malnutrition

Keywords

AgricultureFoodMicronutrientsPregnancyInfantsWomen's groupsBangladesh

Outcome Measures

Primary Outcomes (1)

  • Linear growth in children below 3 years of age

    Length/height-for-age Z-score

    Measured 50 months after randomization (endline survey 2019)

Secondary Outcomes (20)

  • Linear growth in children aged 6-30 months

    Measured 50 months after randomization

  • Intrauterine growth retardation: length

    Measured within 3 days of birth, 15-57 months after randomization

  • Intrauterine growth retardation: small-for-gestational age

    Measured within 3 days of birth, 15-57 months after randomization

  • Intrauterine growth retardation: head size

    Measured within 3 days of birth, 15-57 months after randomization

  • Wasting in children below 3 years of age

    Measured 50 months after randomization

  • +15 more secondary outcomes

Study Arms (2)

Homestead Food Production

EXPERIMENTAL

Enrolled in Homestead Food Production program from 2015 to 2019, 48 clusters, approx. 1350 women and 750 children

Behavioral: Homestead Food Production program

Control

NO INTERVENTION

(Health system strengthening in the study area), 48 clusters, approx. 1350 women and 750 children

Interventions

Homestead Food Production programBEHAVIORAL

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).

Also known as: Agriculture, Home gardening, Nutrition education
Homestead Food Production

Eligibility Criteria

Age15 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • For women:
  • Lack of interest in participating in a gardening program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Wendt AS, Waid JL, Muller-Hauser AA, Lambrecht NJ, Huda TMN, Kyei NNA, Gabrysch S. Impacts of a Homestead Food Production Intervention on Anaemia and Micronutrient Deficiencies Among Women and Children in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Matern Child Nutr. 2025 Oct;21(4):e70043. doi: 10.1111/mcn.70043. Epub 2025 May 19.

    PMID: 40387380DERIVED

  • Sobhan S, Muller-Hauser AA, Gon G, Nurul Huda TM, Waid JL, Wendt AS, Rahman M, Gabrysch S. Effect of a behaviour change intervention on household food hygiene practices in rural Bangladesh: A cluster-randomised controlled trial. Int J Hyg Environ Health. 2024 Jan;255:114291. doi: 10.1016/j.ijheh.2023.114291. Epub 2023 Nov 18.

    PMID: 37983985DERIVED

  • Waid JL, Wendt AS, Kader A, Sobhan S, Gabrysch S. Impact of a Homestead Food Production Program on Dietary Diversity: Seasonal and Annual Results from the Cluster-Randomized FAARM Trial in Sylhet, Bangladesh. J Nutr. 2024 Jan;154(1):191-201. doi: 10.1016/j.tjnut.2023.10.014. Epub 2023 Oct 21.

    PMID: 37871747DERIVED

  • Muller-Hauser AA, Huda TMN, Sobhan S, Lambrecht NJ, Waid JL, Wendt AS, Ali S, Rahman M, Gabrysch S. Effect of a Homestead Food Production and Food Hygiene Intervention on Biomarkers of Environmental Enteric Dysfunction in Children Younger Than 24 Months in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Oct 2;109(5):1166-1176. doi: 10.4269/ajtmh.23-0153. Print 2023 Nov 1.

    PMID: 37783459DERIVED

  • Lambrecht NJ, Muller-Hauser AA, Sobhan S, Schmidt WP, Huda TMN, Waid JL, Wendt AS, Kader A, Gabrysch S. Effect of a Homestead Food Production Program on the Prevalence of Diarrhea and Acute Respiratory Infection in Children in Sylhet, Bangladesh: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Aug 14;109(4):945-956. doi: 10.4269/ajtmh.23-0152. Print 2023 Oct 4.

    PMID: 37580032DERIVED

  • 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.

    PMID: 35045859DERIVED

  • 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.

    PMID: 31620671DERIVED

  • 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.

    PMID: 31278109DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

AgricultureNutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Technology, Industry, and AgricultureData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Sabine Gabrysch, MD MSc PhD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Unit of Epidemiology and Biostatistics, Institute of Global Health

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 22, 2015

Study Start

March 14, 2015

Primary Completion

February 15, 2020

Study Completion

August 30, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05