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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
Sabine Gabrysch
About
Eligibility
Locations
Arms
Outcomes
Full info

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

15 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

    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
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    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

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    Food and Agricultural Approaches to Reducing Malnutrition

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