Bangladesh MSNP: Agricultural/Livelihood Mixed Methods Study (HFP MSNP)

February 2, 2021 updated by: FHI 360

Bangladesh Multi-Sectoral Nutrition Project: Agricultural/Livelihood Mixed Methods Study

Despite progress in reducing high levels of undernutrition in Bangladesh, gaps in progress persist. They are particularly acute between rural and urban areas, and between the lowest wealth quintile and highest. According to the 2016 Bangladesh DHS report, 38% of rural children under five were stunted compared to 31% of urban children. Forty-nine percent of children in the lowest wealth quintile were stunted compared to 19% in the highest.

To address these discrepancies and lower the overall level of stunting, research is being conducted to assist the government of Bangladesh (GoB) in determining the most effective ways to reduce levels of stunting. In particular, positive correlations between household production and consumption of nutritious food have been widely documented by development organizations in Bangladesh. However, information on how to optimize the delivery of household food production programs is needed.

The primary objective of this study is to compare the effectiveness of current standard practice with two multisectoral intervention packages focused on homestead food production:

  1. Homestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services
  2. HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services

The study's primary outcome is the percentage of children 6-23 months old receiving a minimum acceptable diet (MAD), as a proximate determinant for stunting. MAD is defined as the proportion of children 6-23 months old who receive both the minimum feeding frequency and minimum dietary diversity for their age group and breastfeeding status. It will be assessed based on the mother/caregiver report. Secondary outcomes include assessing the knowledge, attitudes, and practices around breastfeeding, complementary feeding, water sanitation and hygiene, health services and gender norms. Quantitative surveys, in depth interviews, focus group discussions, report reviews and process documentation will be used to assess intervention strengths, weakness, and cost effectiveness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to the 2014 Bangladesh Demographic and Health Survey (BDHS), 36% of children under the age of five were stunted, 14% were wasted and 33% were underweight. These results reflect positive trends in stunting and underweight since 2004, though the rate of decline in undernutrition slowed from 2011 to 2014. And, despite positive trends, there remain gaps in key indicators between rural and urban areas and between those in the highest and lowest wealth quintiles. For instance, according to the BDHS, 38% of rural children under five were stunted compared to 31% of urban children. The wealth discrepancies are even greater; 49% of children under five in the lowest wealth quintile were stunted compared to 19% in the highest quintile.

In 2017, the GoB approved the second National Plan of Action for Nutrition (NPAN 2) 2016-2025. The plan aims to improve nutrition and eliminate malnutrition, with a focus on children, adolescent girls, and pregnant and lactating women. Specific targets of NPAN 2 include reducing stunting to 25% among children under 5; reducing wasting to less than 8% and reducing underweight to less than 15%. A significant acceleration in the annual rate of reduction to 3.3% needs to occur in order to achieve the ambitious Targets by 2025. This acceleration requires high-level political commitment, a strong policy framework, effective coordinating mechanisms, adequate resourcing, strong involvement of local civil society groups, and high impact, cost-effective, multisectoral nutrition interventions.

In 2017, USAID awarded FHI 360 the Strengthening Multisectoral Nutrition Programming through Implementation Science Activity (hereafter referred to as "the Project") to test and refine multisectoral nutrition approaches in high stunting areas of Bangladesh. Under the Project, research is being conducted to assess the effect of different multisectoral nutrition intervention packages aimed at improving nutrition outcomes that are known to contribute to overall healthy nutritional status of children under two in Bangladesh. One of the intervention packages to be studied by the Project focuses on integrated agricultural and livelihood activities, known as homestead food production (HFP). This protocol describes a cluster randomized controlled trial (cRCT) to compare two different HFP interventions to the current standard of practice. The two interventions:

  1. Homestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services
  2. HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services

A cluster-randomized, controlled trial (cRCT) design will be used to evaluate effectiveness. The interventions will be delivered at the level of the union, which is a geo-political unit with an average population of 25,000 people. A total of 45 unions in Khulna and Barishal Divisions of Bangladesh will be randomly allocated to one of the three study arms: Control (Current Practice), HFP intervention through community farmers (plus SBCC and strengthened health services), or HFP intervention through retailers (plus SBCC and strengthened health services) . Outcome data will be collected through face-to-face interviews using structured questionnaires with independently selected random samples of mothers/caregivers of children ages 6 to 23 months at baseline (pre-intervention) and again at endline. At both timepoints, participants will be chosen from a sub-sample of the general population who meet the eligibility criteria. Baseline data will be conducted prior to initiation of study activities. Endline data collection will be conducted after two years.

A process evaluation will be completed between baseline and endline to understand how well the interventions were implemented, their costs, and ways they may be improved.

The final evaluation of the cRCT to be done at endline, and will focus on comparing the effect of the intervention on the study outcomes. The study's primary outcome is the percentage of children 6-23 months old receiving a minimum acceptable diet (MAD), as a proximate determinant for stunting. MAD is defined as the proportion of children 6-23 months old who receive both the minimum feeding frequency and minimum dietary diversity for their age group and breastfeeding status. It will be assessed based on the mother/caregiver report. Secondary outcomes include assessing the knowledge, attitudes, and practices around breastfeeding, complementary feeding, water sanitation and hygiene, health services and gender norms.

It is anticipated an analysis of covariance (ANCOVA) approach will be used for a post-only comparison of study arms with possible adjustment for baseline levels in an aggregate manner (note: aggregation for baseline adjustment will be needed given the independent samples selected at each time point). Generalized mixed models will be used to compare the study groups; the will be adjustment for clustering at the Union level. A logit link will be used for the primary outcome as it is a dichotomous outcome, while other link functions will be used for other outcomes as appropriate. The comparison of each intervention to the standard of practice is the primary evaluation focus, while the comparison between intervention groups secondary, as the interventions' effects are not expected to be very different from each other. Adjustment for multiple comparisons is not anticipated. The main analysis will use an intention-to-treat (ITT) approach, where study participants' outcomes are analyzed in the study arm the Union was randomized to, regardless of whether or how much they have been exposed to the intervention.

Study Type

Interventional

Enrollment (Actual)

4067

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • mother/caregiver of child 6-23 months of age
  • Child 6-23 months is mothers 1st or second (living) child
  • resides in an extreme poor or poor household, which is defined in Barishal as less than BDT 2056/month on household expenditures or in Khulna as less than BDT 2019/month on household expenditures

Note: study inclusion criteria is different from intervention enrollee criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFP Intervention: Delivery by Community Farmers

HFP- Delivered by community farmers, supported by the study and linked to eligible households to educate on growing nutritious food and poultry rearing or fish culture

Strengthen referrals to health services- Improvements to referral networks will be implemented. Female community nutrition promoters (CNPs) will refer PLW to service delivery points; gradually this will be completed by peer leaders

Improving quality of health services- Health-related service providers will be trained and supervised on nutrition best practices

SBCC- Primary target is PLW. Delivered using traditional and digital channels. Voice messages will be sent to PLW twice per week. Family members (e.g. husband) will also be encouraged to sign up for different weekly messages. Mothers' groups consisting of ten or fewer will be established. Female CNPs will deliver SBCC during monthly mothers' group meetings, household visits, and in health facilities. CNP's role will later be replaced by peer leaders
Other: HFP Intervention: Delivered by Community Farmers
Homestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services
Experimental: HFP Intervention: Delivery by agricultural Retailers

HFP- Delivered by agricultural Retailers, supported by the study and linked to eligible households to educate on growing nutritious food and either poultry raring or fish culture

Strengthen referrals to health services- Improvements to referral networks will be implemented. Female CNPs will refer PLW to service delivery points; gradually this will be completed by peer leaders

Improving quality of health services- Health-related service providers will be trained and supervised on nutrition best practices

SBCC- Primary target is PLW. Delivered using traditional and digital channels. Voice messages will be sent to PLW twice per week. Family members (e.g. husband) will also be encouraged to sign up for different weekly messages. Mothers' groups consisting of ten or fewer will be established. Female CNPs will deliver SBCC during monthly mothers' group meetings, household visits, and in health facilities. CNP's role will be replaced by peer leaders
Other: HFP Intervention: Delivered by agricultural Retailers
HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services
Active Comparator: Standard of Practice
The standard of care includes nutrition and health services provided to all pregnant women and mothers of children under-2 as provided by the GoB and their supporting partners. Services that should be provided include clinic-level infant and young child feeding (IYCF) counseling, growth monitoring and promotion, immunization, iron and folic acid distribution for pregnant women, ANC, safe delivery at community and referral for complications, vitamin-A supplements for postpartum women and children, deworming and management of common childhood illness.
Other: Control
Current Standard of Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the proportion of children 6-23 months receiving Minimum Acceptable Diet based on mother/caregiver report
Time Frame: This outcome will be assessed not earlier than 22 months after the introduction of the interventions
Minimum Acceptable Diet (MAD) is defined as children by WHO as the proportion of children 6-23 months of age who receive both the minimum feeding frequency and minimum dietary diversity for their age group and breastfeeding status
This outcome will be assessed not earlier than 22 months after the introduction of the interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FHI 360

Collaborators

United States Agency for International Development (USAID)

Investigators

  • Principal Investigator: Theresa Hoke, PhD, FHI 360
  • Principal Investigator: Taufique Jorder, DrPH, FHI 360

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2018

Primary Completion (Actual)

June 28, 2020

Study Completion (Actual)

June 28, 2020

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234890-6
  • 14165566 (Other Identifier: FHI/PHSC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared in accordance with USAID's open data policy.

IPD Sharing Time Frame

Approximately January 2022

IPD Sharing Access Criteria

Data will be made available upon request, submitted with a brief concept describing intended use of data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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