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Food and Agricultural Approaches to Reducing Malnutrition (FAARM)

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ClinicalTrials.gov Identifier: NCT02505711
Recruitment Status : Enrolling by invitation
First Posted : July 22, 2015
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Helen Keller International
BRAC University
University of Giessen
German Federal Ministry of Education and Research
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Sabine Gabrysch, Heidelberg University

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 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
Study Start Date : August 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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



Primary Outcome Measures :
  1. Linear growth in children below 3 years of age [ Time Frame: Measured 50 months after randomization (endline survey 2019) ]
    Length-for-age Z-score


Secondary Outcome Measures :
  1. Linear growth in children aged 6-30 months [ Time Frame: Measured 50 months after randomization ]
    Length-for-age Z-score

  2. Intrauterine growth retardation: length [ Time Frame: Measured within 3 days of birth, 15-50 months after randomization ]
    Length-for-gestational-age

  3. Intrauterine growth retardation: small-for-gestational age [ Time Frame: Measured within 3 days of birth, 15-50 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, 15-50 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 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, 6-50 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 Ages & Stages Questionnaire) [ 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 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 3 years of age [ Time Frame: Measured 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

  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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505711


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
Investigators
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Principal Investigator: Sabine Gabrysch, MD MSc PhD Heidelberg University

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Responsible Party: Sabine Gabrysch, Head, Unit of Epidemiology and Biostatistics, Institute of Public Health, Heidelberg University
ClinicalTrials.gov Identifier: NCT02505711     History of Changes
Other Study ID Numbers: 01ER1201
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by Sabine Gabrysch, Heidelberg University:
Agriculture
Food
Micronutrients
Pregnancy
Infants
Women's groups
Bangladesh

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders