Clinical trial NCT02505711: Food and Agricultural Approaches to Reducing Malnutrition
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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Agriculture
Food
Micronutrients
Pregnancy
Infants
Women's groups
Bangladesh
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Helen Keller International
name: BRAC University
name: University of Giessen
name: German Federal Ministry of Education and Research
name: Department for International Development, United Kingdom
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: German Research Foundation
First posted: 2015-07-22
Enrollment: 2705
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Linear growth in children below 3 years of age
timeFrame: Measured 50 months after randomization (endline survey 2019)
Secondary outcomes:
measure: Linear growth in children aged 6-30 months
timeFrame: Measured 50 months after randomization
measure: Intrauterine growth retardation: length
timeFrame: Measured within 3 days of birth, 15-57 months after randomization
measure: Intrauterine growth retardation: small-for-gestational age
timeFrame: Measured within 3 days of birth, 15-57 months after randomization
measure: Intrauterine growth retardation: head size
timeFrame: Measured within 3 days of birth, 15-57 months after randomization
measure: Wasting in children below 3 years of age
timeFrame: Measured 50 months after randomization
measure: Head circumference in children below 3 years of age
timeFrame: Measured 50 months after randomization
measure: Underweight in women
timeFrame: Measured 50 months after randomization
measure: Gestational weight gain
timeFrame: Measured every 2 months during pregnancy, 6-57 months after randomization
measure: Anemia in women and children below 3 years of age
timeFrame: Measured 50 months after randomization
measure: Micronutrients: Vitamin A deficiency in women and in children below 3 years of age
timeFrame: Measured 50 months after randomization
measure: Micronutrients: Iron deficiency in women and in children below 3 years of age
timeFrame: Measured 50 months after randomization
measure: Micronutrients: Zinc deficiency in women and in children below 3 years of age
timeFrame: Measured 50 months after randomization
measure: Early child development (adapted WHO milestones)
timeFrame: Measured at appropriate ages for milestones, 6-50 months after randomization
measure: Diarrhea in children below 3 years of age
timeFrame: Measured every 2 months, 6-50 months after randomization
measure: Acute respiratory infection in children below 3 years of age
timeFrame: Measured every 2 months, 6-50 months after randomization
measure: Enteropathy in children below 18 months of age
timeFrame: Measured 36 and 50 months after randomization
measure: Dietary adequacy in women and children below 3 years of age
timeFrame: Measured every 2 months, 6-50 months after randomization
measure: Dietary diversity in women and children below 3 years of age
timeFrame: Measured every 2 months, 6-50 months after randomization
measure: Fecal contamination of complementary food for children 6-18 months of age
timeFrame: Measured 36 months after randomization
measure: Food hygiene behaviour in mothers of children aged 6-18 months
timeFrame: Measured 36 months after randomization
Other outcomes:
Locations:
Study officials:
affiliation: Heidelberg University
name: Sabine Gabrysch, MD MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.