NCT04166370

Bangladesh MSNP: Social Protection Mixed Methods Study

Withdrawn NA Last updated 5 February 2021

What this trial tests

NA trial testing Control in Stunting. Withdrawn.

Timeline

26 July 2018

Primary endpoint
28 June 2020

28 June 2020

Quick facts

Lead sponsor	FHI 360
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Start date	26 July 2018
Primary completion	28 June 2020
Estimated completion	28 June 2020
Sites	1 location across Bangladesh

Drugs / interventions tested

• Control
• Strengthened (Services and SBCC)
• Strengthened (Services and SBCC) + CCT

Conditions studied

• Stunting — all drugs for Stunting →
• Undernutrition — all drugs for Undernutrition →

Sponsor

FHI 360 — full company profile →

Who can join

18 and older, female only, with Stunting or Undernutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Community-level interventions for improving access to food in low- and middle-income countries.
   Durao S, Visser ME, Ramokolo V, Oliveira JM, et al · · 2020 · cited 33× · PMID 32722849 · DOI 10.1002/14651858.cd011504.pub2
2. Community-level interventions for improving access to food in low- and middle-income countries.
   Durao S, Visser ME, Ramokolo V, Oliveira JM, et al · · 2020 · cited 23× · PMID 32761615 · DOI 10.1002/14651858.cd011504.pub3