NCT04185597

Brief Summary

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. 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. 2.HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,067

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2020

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

December 2, 2019

Last Update Submit

February 2, 2021

Conditions

StuntingUndernutrition

Keywords

BangladeshNutritionMulti-sectoralRandomizedHousehold food production

Outcome Measures

Primary Outcomes (1)

  • Difference in the proportion of children 6-23 months receiving Minimum Acceptable Diet based on mother/caregiver report

    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

Study Arms (3)

HFP Intervention: Delivery by Community Farmers

EXPERIMENTAL

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

HFP Intervention: Delivery by agricultural Retailers

EXPERIMENTAL

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

Standard of Practice

ACTIVE COMPARATOR

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

Interventions

HFP Intervention: Delivered by Community FarmersOTHER

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

HFP Intervention: Delivery by Community Farmers
HFP Intervention: Delivered by agricultural RetailersOTHER

HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services

HFP Intervention: Delivery by agricultural Retailers
ControlOTHER

Current Standard of Practice

Standard of Practice

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FHI 360

Dhaka, Bangladesh

Location

Related Publications (15)

  • BNNC (2017). Second National Plan of Action on Nutrition. Dhaka. Bangladesh National Nutrition Council (BNNC), 2017

    BACKGROUND

  • Ahmed AU, et al. Which Kinds of Social Safety Net Transfers Work Bets for the Ultra Poor in Bangladesh? Operation and Impacts of the Transfer Modality Research Initiative. Dhaka, IFPRI and WFP, 2016.

    BACKGROUND

  • Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

    PMID: 23746772BACKGROUND

  • BBS (2017). Preliminary Report on Household Income and Expenditure Survey 2016. Dhaka, Bangladesh Bureau of Statistics (BBS), 2017.

    BACKGROUND

  • Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.

    PMID: 18207566BACKGROUND

  • FHI 360 (2016). SHIKHA Project Final Report. Dhaka, Bangladesh: FHI 360

    BACKGROUND

  • Food and Nutrition Technical Assistance III Project (FANTA). 2017. Multisectoral Nutrition Programming: FANTA Achievements and Lessons Learned. Washington, DC: FHI 360/ FANTA.

    BACKGROUND

  • GoB. Bangladesh 2nd National Plan of Action (NPAN2) 2016-2025. 2015. Dhaka, Government of Bangladesh.

    BACKGROUND

  • Islam F. National Social Security Strategy (NSSS): Progress of Action Plan preparation. Presented at the Technical Symposium on Nutrition Sensitive Social Protection in Bangladesh, December 2017.

    BACKGROUND

  • MI. (2009). Investing in the future: A united call to action on vitamin and mineral deficiencies: Micronutrient Initiative

    BACKGROUND

  • National Institute of Population Research and Training (NIPORT), Mitra and Associates, and ICF International. 2016. Bangladesh Demographic and Health Survey 2014. Dhaka, Bangladesh, and Rockville, Maryland, USA: NIPORT, Mitra and Associates, and ICF International

    BACKGROUND

  • Save the Children (2012). Nutrition in the First 1000 Days: State of the World's Mothers 2012 Save the Children

    BACKGROUND

  • Essential Nutrition Actions: Improving Maternal, Newborn, Infant and Young Child Health and Nutrition. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK258736/

    PMID: 25473713BACKGROUND

  • Arimond M, Daelmans B, Dewey K; Steering Team of the Working Group on Infant and Young Child Feeding Indicators. Indicators for feeding practices in children. Lancet. 2008 Feb 16;371(9612):541-2. doi: 10.1016/S0140-6736(08)60250-0. No abstract available.

    PMID: 18280315BACKGROUND

  • WHO, UNICEF, and USAID. (2015). Improving Nutrition Outcomes with Better Water, Sanitation and Hygiene: Practical Solutions for Policies and Programmes. Switzerland: WHO

    BACKGROUND

MeSH Terms

Conditions

Growth DisordersMalnutrition

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Theresa Hoke, PhD

    FHI 360

    PRINCIPAL INVESTIGATOR

  • Taufique Jorder, DrPH

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: cluster-randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 4, 2019

Study Start

July 7, 2018

Primary Completion

June 28, 2020

Study Completion

June 28, 2020

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

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

Time Frame
Approximately January 2022
Access Criteria
Data will be made available upon request, submitted with a brief concept describing intended use of data.

Locations

BA(1)