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Completed

NCT Number: NCT02505711

Food and Agricultural Approaches to Reducing Malnutrition

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.

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Key information

Age range

15 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homestead Food Production program

Behavioral

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

Primary outcomes

  1. Linear growth in children below 3 years of age

    Time frame: Measured 50 months after randomization (endline survey 2019)

    Length/height-for-age Z-score

Secondary outcomes

  1. Linear growth in children aged 6-30 months

    Time frame: Measured 50 months after randomization

    Length/height-for-age Z-score

  2. Intrauterine growth retardation: length

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

    Length-for-gestational-age

  3. Intrauterine growth retardation: small-for-gestational age

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

    Weight-for-gestational-age adjusted for time since birth

  4. Intrauterine growth retardation: head size

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

    Head circumference-for-gestational-age

  5. Wasting in children below 3 years of age

    Time frame: Measured 50 months after randomization

    Weight-for-length/height Z-score

  6. Head circumference in children below 3 years of age

    Time frame: Measured 50 months after randomization

    Head circumference-for-age Z-score

  7. Underweight in women

    Time frame: Measured 50 months after randomization

    Body Mass Index (BMI, non-pregnant women), mid-upper-arm circumference (MUAC, pregnant women)

  8. Gestational weight gain

    Time frame: Measured every 2 months during pregnancy, 6-57 months after randomization

    Gestational weight gain Z-score

  9. Anemia in women and children below 3 years of age

    Time frame: Measured 50 months after randomization

    Hemoglobin concentration

  10. Micronutrients: Vitamin A deficiency in women and in children below 3 years of age

    Time frame: Measured 50 months after randomization

    Retinol-binding protein, corrected for inflammation (CRP, AGP)

  11. Micronutrients: Iron deficiency in women and in children below 3 years of age

    Time frame: Measured 50 months after randomization

    Ferritin and soluble transferrin receptor, corrected for inflammation (CRP, AGP)

  12. Micronutrients: Zinc deficiency in women and in children below 3 years of age

    Time frame: Measured 50 months after randomization

    Serum zinc, corrected for inflammation (CRP, AGP)

  13. Early child development (adapted WHO milestones)

    Time frame: Measured at appropriate ages for milestones, 6-50 months after randomization

    Gross and fine motor, cognitive, personal-social and communication skills

  14. Diarrhea in children below 3 years of age

    Time frame: Measured every 2 months, 6-50 months after randomization

    Period and point prevalence of diarrhea

  15. Acute respiratory infection in children below 3 years of age

    Time frame: Measured every 2 months, 6-50 months after randomization

    Period prevalence of acute respiratory infection

  16. Enteropathy in children below 18 months of age

    Time frame: Measured 36 and 50 months after randomization

    Biomarkers: faecal myeloperoxidase, faecal α1-antitrypsin, faecal neopterin, serum C-reactive protein, serum α-1-acid glycoprotein

  17. Dietary adequacy in women and children below 3 years of age

    Time frame: Measured every 2 months, 6-50 months after randomization

    Mean probability of adequate micronutrient intake (MPA)

  18. Dietary diversity in women and children below 3 years of age

    Time frame: Measured every 2 months, 6-50 months after randomization

    Individual dietary diversity score, breastfeeding behaviors

  19. Fecal contamination of complementary food for children 6-18 months of age

    Time frame: Measured 36 months after randomization

    Log-transformed counts of total coliforms and E. coli in complementary food samples

  20. Food hygiene behaviour in mothers of children aged 6-18 months

    Time frame: Measured 36 months after randomization

    Hygiene score from structured observation of mothers

Sponsors and collaborators

Lead sponsor

Sabine Gabrysch

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FAARM

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jul 22, 2015
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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