NCT04166370

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. The primary objective of this research is to compare the effectiveness of two multisectoral nutrition intervention packages--one with and without a conditional cash transfer (CCT) component--to the current standard of practice. A cluster-randomized controlled trial using mixed methods will be used to evaluate effectiveness. The two intervention arms are as follows;

  • Strengthened: Referrals to health services, strengthened health services, and enhanced social and behavior change communication (SBCC)
  • Strengthened + CCT: Referrals to health services, strengthened health services, enhanced SBCC and cash transfers conditional on a mother attending antenatal care (ANC) and monthly nutrition education SBCC group sessions. 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, and detailed program monitoring data will be used to assess intervention strengths, weakness, and cost effectiveness.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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 26, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 18, 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 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

October 15, 2019

Last Update Submit

February 2, 2021

Conditions

StuntingUndernutrition

Keywords

BangladeshMultisectoralCash TransferRandomized

Outcome Measures

Primary Outcomes (1)

  • Change 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)

Standard of Practice

ACTIVE COMPARATOR

Current Standard of Practice

Other: Control

Strengthened Services and Social Behavioral Change (SBCC)

EXPERIMENTAL

Increase referrals to health services, strengthen health services, and provide enhanced social and behavior change communication (SBCC)

Other: Strengthened (Services and SBCC)

Strengthened Services and SBCC plus Conditional Cash Transfer

EXPERIMENTAL

Increase referrals to health services, strengthenhealth services, provide enhanced SBCC, as well as cash transfers that are conditional on a mother attending antenatal care (ANC) and monthly nutrition education SBCC group sessions.

Other: Strengthened (Services and SBCC) + CCT

Interventions

ControlOTHER

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.

Standard of Practice
Strengthened (Services and SBCC)OTHER

Strengthening referrals to health services- Needed improvements to existing health referral networks will be assessed, identified and implemented. Peer leaders will refer PLW to nearby service delivery points. Improving quality of health/nutrition services- Health-related service providers will be trained and supervised on nutrition best practices. SBCC- Primarily target PLW. Delivered using traditional and digital channels. Text/voice messages will be sent to PLW twice per week. Family members (e.g. husband) will also be encouraged to sign up for these messages. Female community nutrition promoters will also be deployed; delivering SBCC during group meetings and in health facilities. Mothers' groups will be established, and will be led by peer leaders, mentored in the delivery of messages on nutrition behavior.

Strengthened Services and Social Behavioral Change (SBCC)
Strengthened (Services and SBCC) + CCTOTHER

Will include all components of the strengthened intervention and participants will receive monthly cash transfers, which is about 25% of monthly consumption expenditure among poor rural households in Bangladesh. Cash transfers will begin when a woman enrolls (at any time during her pregnancy or until 2 months after giving birth). The monthly transfer will continue until a child is 12 months of age, thereby supporting mothers during the critical period of complementary food introduction. The transfer is contingent on having had a minimum of 4 ANC visits and monthly participation in mother's group SBCC sessions.

Strengthened Services and SBCC plus Conditional Cash Transfer

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 household, which is defined in Barishal as less than BDT 1778/month on household expenditures or in Khulna as less than BDT 1677/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

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

    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

  • 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

  • WHO (2008). Indicators for assessing infant and young child feeding practices, part 1: definitions

    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

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

    BACKGROUND

Related Links

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
0

Study Design

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

Study Record Dates

First Submitted

October 15, 2019

First Posted

November 18, 2019

Study Start

July 26, 2018

Primary Completion

June 28, 2020

Study Completion

June 28, 2020

Last Updated

February 5, 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)