Food and Agricultural Approaches to Reducing Malnutrition (FAARM)
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Homestead Food Production program
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring Agriculture, Food, Micronutrients, Pregnancy, Infants, Women's groups, Bangladesh
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Homestead Food Production
Control
Arm Description
Enrolled in Homestead Food Production program from 2015 to 2019, 48 clusters, approx. 1350 women and 750 children
(Health system strengthening in the study area), 48 clusters, approx. 1350 women and 750 children
Outcomes
Primary Outcome Measures
Linear growth in children below 3 years of age
Length/height-for-age Z-score
Secondary Outcome Measures
Linear growth in children aged 6-30 months
Length/height-for-age Z-score
Intrauterine growth retardation: length
Length-for-gestational-age
Intrauterine growth retardation: small-for-gestational age
Weight-for-gestational-age adjusted for time since birth
Intrauterine growth retardation: head size
Head circumference-for-gestational-age
Wasting in children below 3 years of age
Weight-for-length/height Z-score
Head circumference in children below 3 years of age
Head circumference-for-age Z-score
Underweight in women
Body Mass Index (BMI, non-pregnant women), mid-upper-arm circumference (MUAC, pregnant women)
Gestational weight gain
Gestational weight gain Z-score
Anemia in women and children below 3 years of age
Hemoglobin concentration
Micronutrients: Vitamin A deficiency in women and in children below 3 years of age
Retinol-binding protein, corrected for inflammation (CRP, AGP)
Micronutrients: Iron deficiency in women and in children below 3 years of age
Ferritin and soluble transferrin receptor, corrected for inflammation (CRP, AGP)
Micronutrients: Zinc deficiency in women and in children below 3 years of age
Serum zinc, corrected for inflammation (CRP, AGP)
Early child development (adapted WHO milestones)
Gross and fine motor, cognitive, personal-social and communication skills
Diarrhea in children below 3 years of age
Period and point prevalence of diarrhea
Acute respiratory infection in children below 3 years of age
Period prevalence of acute respiratory infection
Enteropathy in children below 18 months of age
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
Mean probability of adequate micronutrient intake (MPA)
Dietary diversity in women and children below 3 years of age
Individual dietary diversity score, breastfeeding behaviors
Fecal contamination of complementary food for children 6-18 months of age
Log-transformed counts of total coliforms and E. coli in complementary food samples
Food hygiene behaviour in mothers of children aged 6-18 months
Hygiene score from structured observation of mothers
Full Information
NCT ID
NCT02505711
First Posted
July 17, 2015
Last Updated
May 17, 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
1. Study Identification
Unique Protocol Identification Number
NCT02505711
Brief Title
Food and Agricultural Approaches to Reducing Malnutrition
Acronym
FAARM
Official Title
Reducing Young Child Undernutrition Through an Integrated Agricultural Project With Women's Groups: A Cluster-randomized Trial in Rural Bangladesh
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 14, 2015 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Agriculture, Food, Micronutrients, Pregnancy, Infants, Women's groups, Bangladesh
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2705 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Homestead Food Production
Arm Type
Experimental
Arm Description
Enrolled in Homestead Food Production program from 2015 to 2019, 48 clusters, approx. 1350 women and 750 children
Arm Title
Control
Arm Type
No Intervention
Arm Description
(Health system strengthening in the study area), 48 clusters, approx. 1350 women and 750 children
Intervention Type
Behavioral
Intervention Name(s)
Homestead Food Production program
Other Intervention Name(s)
Agriculture, Home gardening, Nutrition education
Intervention Description
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).
Primary Outcome Measure Information:
Title
Linear growth in children below 3 years of age
Description
Length/height-for-age Z-score
Time Frame
Measured 50 months after randomization (endline survey 2019)
Secondary Outcome Measure Information:
Title
Linear growth in children aged 6-30 months
Description
Length/height-for-age Z-score
Time Frame
Measured 50 months after randomization
Title
Intrauterine growth retardation: length
Description
Length-for-gestational-age
Time Frame
Measured within 3 days of birth, 15-57 months after randomization
Title
Intrauterine growth retardation: small-for-gestational age
Description
Weight-for-gestational-age adjusted for time since birth
Time Frame
Measured within 3 days of birth, 15-57 months after randomization
Title
Intrauterine growth retardation: head size
Description
Head circumference-for-gestational-age
Time Frame
Measured within 3 days of birth, 15-57 months after randomization
Title
Wasting in children below 3 years of age
Description
Weight-for-length/height Z-score
Time Frame
Measured 50 months after randomization
Title
Head circumference in children below 3 years of age
Description
Head circumference-for-age Z-score
Time Frame
Measured 50 months after randomization
Title
Underweight in women
Description
Body Mass Index (BMI, non-pregnant women), mid-upper-arm circumference (MUAC, pregnant women)
Time Frame
Measured 50 months after randomization
Title
Gestational weight gain
Description
Gestational weight gain Z-score
Time Frame
Measured every 2 months during pregnancy, 6-57 months after randomization
Title
Anemia in women and children below 3 years of age
Description
Hemoglobin concentration
Time Frame
Measured 50 months after randomization
Title
Micronutrients: Vitamin A deficiency in women and in children below 3 years of age
Description
Retinol-binding protein, corrected for inflammation (CRP, AGP)
Time Frame
Measured 50 months after randomization
Title
Micronutrients: Iron deficiency in women and in children below 3 years of age
Description
Ferritin and soluble transferrin receptor, corrected for inflammation (CRP, AGP)
Time Frame
Measured 50 months after randomization
Title
Micronutrients: Zinc deficiency in women and in children below 3 years of age
Description
Serum zinc, corrected for inflammation (CRP, AGP)
Time Frame
Measured 50 months after randomization
Title
Early child development (adapted WHO milestones)
Description
Gross and fine motor, cognitive, personal-social and communication skills
Time Frame
Measured at appropriate ages for milestones, 6-50 months after randomization
Title
Diarrhea in children below 3 years of age
Description
Period and point prevalence of diarrhea
Time Frame
Measured every 2 months, 6-50 months after randomization
Title
Acute respiratory infection in children below 3 years of age
Description
Period prevalence of acute respiratory infection
Time Frame
Measured every 2 months, 6-50 months after randomization
Title
Enteropathy in children below 18 months of age
Description
Biomarkers: faecal myeloperoxidase, faecal α1-antitrypsin, faecal neopterin, serum C-reactive protein, serum α-1-acid glycoprotein
Time Frame
Measured 36 and 50 months after randomization
Title
Dietary adequacy in women and children below 3 years of age
Description
Mean probability of adequate micronutrient intake (MPA)
Time Frame
Measured every 2 months, 6-50 months after randomization
Title
Dietary diversity in women and children below 3 years of age
Description
Individual dietary diversity score, breastfeeding behaviors
Time Frame
Measured every 2 months, 6-50 months after randomization
Title
Fecal contamination of complementary food for children 6-18 months of age
Description
Log-transformed counts of total coliforms and E. coli in complementary food samples
Time Frame
Measured 36 months after randomization
Title
Food hygiene behaviour in mothers of children aged 6-18 months
Description
Hygiene score from structured observation of mothers
Time Frame
Measured 36 months after randomization
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Gabrysch, MD MSc PhD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
35045859
Citation
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.
Results Reference
derived
PubMed Identifier
31620671
Citation
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.
Results Reference
derived
PubMed Identifier
31278109
Citation
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.
Results Reference
derived
Learn more about this trial
Food and Agricultural Approaches to Reducing Malnutrition
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