Food and Agricultural Approaches to Reducing Malnutrition (FAARM)

• ClinicalTrials.gov Identifier: NCT02505711
• Recruitment Status: Completed
• First Posted: July 22, 2015
• Last Update Posted: May 18, 2022
• Sponsor: Sabine Gabrysch
• Collaborators: Helen Keller International; BRAC University; University of Giessen; German Federal Ministry of Education and Research; Department for International Development, United Kingdom; International Centre for Diarrhoeal Disease Research, Bangladesh; German Research Foundation
• Information provided by (Responsible Party): Sabine Gabrysch, Heidelberg University

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	Not Applicable

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 (Clinical Trial)
• 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: March 14, 2015
• Actual Primary Completion Date: February 15, 2020
• Actual Study Completion Date: August 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 30 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Sabine Gabrysch

Helen Keller International

BRAC University

University of Giessen

German Federal Ministry of Education and Research

Department for International Development, United Kingdom

International Centre for Diarrhoeal Disease Research, Bangladesh

German Research Foundation

Investigators

• Principal Investigator: Sabine Gabrysch, MD MSc PhD; Heidelberg University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sabine Gabrysch, Head, Unit of Epidemiology and Biostatistics, Institute of Global Health, Heidelberg University
• ClinicalTrials.gov Identifier: NCT02505711
• Other Study ID Numbers: 01ER1201
• First Posted: July 22, 2015
• Last Update Posted: May 18, 2022
• Last Verified: May 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sabine Gabrysch, Heidelberg University:

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

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders