Food and Agricultural Approaches to Reducing Malnutrition

Malnutrition Clinical Trial

— FAARM  

Official title:

Reducing Young Child Undernutrition Through an Integrated Agricultural Project With Women's Groups: A Cluster-randomized Trial in Rural Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505711
• Other study ID #: 01ER1201
• Status: Completed
• Phase: N/A
• Start date: March 14, 2015
• Est. completion date: August 30, 2021

Study information

• Verified date: May 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2705
• Est. completion date: August 30, 2021
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Sabine Gabrysch	BRAC University, Department for International Development, United Kingdom, German Federal Ministry of Education and Research, German Research Foundation, Helen Keller International, International Centre for Diarrhoeal Disease Research, Bangladesh, University of Giessen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear growth in children below 3 years of age	Length/height-for-age Z-score	Measured 50 months after randomization (endline survey 2019)
Secondary	Linear growth in children aged 6-30 months	Length/height-for-age Z-score	Measured 50 months after randomization
Secondary	Intrauterine growth retardation: length	Length-for-gestational-age	Measured within 3 days of birth, 15-57 months after randomization
Secondary	Intrauterine growth retardation: small-for-gestational age	Weight-for-gestational-age adjusted for time since birth	Measured within 3 days of birth, 15-57 months after randomization
Secondary	Intrauterine growth retardation: head size	Head circumference-for-gestational-age	Measured within 3 days of birth, 15-57 months after randomization
Secondary	Wasting in children below 3 years of age	Weight-for-length/height Z-score	Measured 50 months after randomization
Secondary	Head circumference in children below 3 years of age	Head circumference-for-age Z-score	Measured 50 months after randomization
Secondary	Underweight in women	Body Mass Index (BMI, non-pregnant women), mid-upper-arm circumference (MUAC, pregnant women)	Measured 50 months after randomization
Secondary	Gestational weight gain	Gestational weight gain Z-score	Measured every 2 months during pregnancy, 6-57 months after randomization
Secondary	Anemia in women and children below 3 years of age	Hemoglobin concentration	Measured 50 months after randomization
Secondary	Micronutrients: Vitamin A deficiency in women and in children below 3 years of age	Retinol-binding protein, corrected for inflammation (CRP, AGP)	Measured 50 months after randomization
Secondary	Micronutrients: Iron deficiency in women and in children below 3 years of age	Ferritin and soluble transferrin receptor, corrected for inflammation (CRP, AGP)	Measured 50 months after randomization
Secondary	Micronutrients: Zinc deficiency in women and in children below 3 years of age	Serum zinc, corrected for inflammation (CRP, AGP)	Measured 50 months after randomization
Secondary	Early child development (adapted WHO milestones)	Gross and fine motor, cognitive, personal-social and communication skills	Measured at appropriate ages for milestones, 6-50 months after randomization
Secondary	Diarrhea in children below 3 years of age	Period and point prevalence of diarrhea	Measured every 2 months, 6-50 months after randomization
Secondary	Acute respiratory infection in children below 3 years of age	Period prevalence of acute respiratory infection	Measured every 2 months, 6-50 months after randomization
Secondary	Enteropathy in children below 18 months of age	Biomarkers: faecal myeloperoxidase, faecal a1-antitrypsin, faecal neopterin, serum C-reactive protein, serum a-1-acid glycoprotein	Measured 36 and 50 months after randomization
Secondary	Dietary adequacy in women and children below 3 years of age	Mean probability of adequate micronutrient intake (MPA)	Measured every 2 months, 6-50 months after randomization
Secondary	Dietary diversity in women and children below 3 years of age	Individual dietary diversity score, breastfeeding behaviors	Measured every 2 months, 6-50 months after randomization
Secondary	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	Measured 36 months after randomization
Secondary	Food hygiene behaviour in mothers of children aged 6-18 months	Hygiene score from structured observation of mothers	Measured 36 months after randomization