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Bangladesh MSNP: Social Protection Mixed Methods Study

Primary Purpose

Stunting, Undernutrition

Status
Withdrawn
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Control
Strengthened (Services and SBCC)
Strengthened (Services and SBCC) + CCT
Sponsored by
FHI 360
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stunting focused on measuring Bangladesh, Multisectoral, Cash Transfer, Randomized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 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

Note: study inclusion criteria is different from intervention enrollee criteria

Sites / Locations

  • FHI 360

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard of Practice

Strengthened Services and Social Behavioral Change (SBCC)

Strengthened Services and SBCC plus Conditional Cash Transfer

Arm Description

Current Standard of Practice

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 15, 2019
Last Updated
February 2, 2021
Sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04166370
Brief Title
Bangladesh MSNP: Social Protection Mixed Methods Study
Official Title
Bangladesh Multisectoral Nutrition Project: Social Protection Mixed Methods Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Stopped due to funding
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
June 28, 2020 (Actual)
Study Completion Date
June 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 studied by the Project focuses on conditional cash transfers (CCT) for social protection. The primary objective of this study is to compare the effectiveness of the current standard of practice with two multisectoral intervention packages--one with and without a CCT intervention. 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. 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 60 unions in Khulna and Barishal Divisions of Bangladesh will be randomly allocated to one of the three study arms: Control (Current Practice), Strengthened Intervention, or Strengthened + CCT Intervention. 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 analysis 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 to compare the study groups and adjust for clustering at the union level will be used. A logit link will be used for the primary outcome (i.e., minimum acceptable diet) as it is a dichotomous outcome, while other link functions will be used for other outcomes as appropriate. It is hypothesized that the intervention arm with the enhanced SBCC will be superior to standard practice. It is further hypothesized that adding CCT along with the enhanced SBCC will produce an even greater effect. These pairwise comparisons will be tested using the model parameter estimates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting, Undernutrition
Keywords
Bangladesh, Multisectoral, Cash Transfer, Randomized

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cluster-randomized, controlled trial (cRCT)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Practice
Arm Type
Active Comparator
Arm Description
Current Standard of Practice
Arm Title
Strengthened Services and Social Behavioral Change (SBCC)
Arm Type
Experimental
Arm Description
Increase referrals to health services, strengthen health services, and provide enhanced social and behavior change communication (SBCC)
Arm Title
Strengthened Services and SBCC plus Conditional Cash Transfer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strengthened (Services and SBCC)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strengthened (Services and SBCC) + CCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the proportion of Children 6-23 months receiving Minimum Acceptable Diet based on mother/caregiver report
Description
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
Time Frame
This outcome will be assessed not earlier than 22 months after the introduction of the interventions

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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 Note: study inclusion criteria is different from intervention enrollee criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Hoke, PhD
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taufique Jorder, DrPH
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
Facility Information:
Facility Name
FHI 360
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
Citation
BNNC (2017). Second National Plan of Action on Nutrition. Dhaka. Bangladesh National Nutrition Council (BNNC), 2017.
Results Reference
background
Citation
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.
Results Reference
background
Citation
BBS (2017). Preliminary Report on Household Income and Expenditure Survey 2016. Dhaka, Bangladesh Bureau of Statistics (BBS), 2017.
Results Reference
background
PubMed Identifier
23746772
Citation
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. Erratum In: Lancet. 2013. 2013 Aug 3;382(9890):396.
Results Reference
background
PubMed Identifier
18207566
Citation
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.
Results Reference
background
Citation
FHI 360 (2016). SHIKHA Project Final Report. Dhaka, Bangladesh: FHI 360.
Results Reference
background
Citation
Food and Nutrition Technical Assistance III Project (FANTA). 2017. Multisectoral Nutrition Programming: FANTA Achievements and Lessons Learned. Washington, DC: FHI 360/ FANTA.
Results Reference
background
Citation
GoB. Bangladesh 2nd National Plan of Action (NPAN2) 2016-2025. 2015. Dhaka, Government of Bangladesh.
Results Reference
background
Citation
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.
Results Reference
background
Citation
MI. (2009). Investing in the future: A united call to action on vitamin and mineral deficiencies: Micronutrient Initiative
Results Reference
background
Citation
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
Results Reference
background
Citation
Save the Children (2012). Nutrition in the First 1000 Days: State of the World's Mothers 2012 Save the Children
Results Reference
background
Citation
WHO (2008). Indicators for assessing infant and young child feeding practices, part 1: definitions
Results Reference
background
PubMed Identifier
25473713
Citation
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/
Results Reference
background
Citation
WHO, UNICEF, and USAID. (2015). Improving Nutrition Outcomes with Better Water, Sanitation and Hygiene: Practical Solutions for Policies and Programmes. Switzerland: WHO
Results Reference
background
Links:
URL
http://data.unicef.org/topic/nutrition/malnutrition
Description
UNICEF. (2018). Child malnutrition estimates

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Bangladesh MSNP: Social Protection Mixed Methods Study

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