Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children

NCT ID: NCT02208531

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-11-30

Brief Summary

We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished children's growth and development after a year of intervention.

Detailed Description

Over 200 million children <5 yrs do not reach their full potential due to poor nutrition and inadequate cognitive stimulation. Nutritional Care (NC) alone is insufficient to correct developmental deficit in malnourished children and psychosocial stimulation (PS) is also required.

Objectives:

1. Pilot two intervention methods and different delivery models of providing NC+PS to refine the intervention and identify any difficulties.

2. Conduct a cluster randomized controlled trial (CRCT) of NC+PS on malnourished children.

3. Pilot the feasibility of providing NC+PS to groups of mothers instead of individuals through a quasi-experimental design.

Methods: The study consists of 3 different sub-studies:

1. The pilot will be a qualitative study conducted in 10 Community Clinics (CCs) involving 40 children (aged 6-33 months) per CC. Mothers and children will attend the clinic every 2 weeks for an hour play session in groups of 2 or 6. We will explore different delivery models and assess problems through focus group discussions with parents and staff of the CCs.

2. For the CRCT we will survey all children aged 6-24 mo in 140 CCs to identify those malnourished. We will then randomize the CCs to NC+PS or control, randomly select 40 children from each CC and evaluate a random subsample of 6 children from each of the CCs using anthropometry, Bayley-III, Wolke's behavior rating and family care indicators (FCI) at baseline and endline.

3. The quasi experimental study will be conducted in 10 CCs randomized to group-intervention or control with 40 mothers and children per CC. Mothers will come to the CCs in groups of 6 with their children every fortnight. The children will be tested at the beginning and after 12 months using the same tools in the main study.

Outcome variable: The main outcomes are children's language, mental and psychomotor development measured on Bayley-III. In addition we expect improvements in FCI and mother's child rearing knowledge and practices. We will also conduct cost analysis and based on the success indicators, cost per successful outcome will be calculated from total cost of intervention program.

Conditions

Moderate and Severe Undernutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Psychosocial Stimulation and Nutritional Care

Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.

Group Type: EXPERIMENTAL

Psychosocial Stimulation and Nutritional Care

Intervention Type: BEHAVIORAL

Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.

Interventions

Psychosocial Stimulation and Nutritional Care

Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Moderately and Severely malnourished children WAZ<-2SD
• Age: 6-24 months
• Both male and female children
• Living within 30 minutes walk from the Community Clinic
• Parents giving consent to participate in the study

Exclusion Criteria

• Severe Acute Malnutrition with complications requiring close monitoring and/or hospitalization
• Severe clinical pallor
• Known chronic diseases like epilepsy, cerebral palsy, mental retardation
• Twin/multiple birth

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, , Bangladesh

Countries

Bangladesh

References

Hossain SJ, Palmer T, Uddin Tipu SMM, Mehrin SF, Shiraji S, Hasan MI, Alam Bhuiyan MS, Salveen NE, Tofail F, Baker-Henningham H, Haghparast-Bidgoli H, Hamadani JD. Cost-effectiveness analysis of two integrated early childhood development programs into Bangladeshi primary health-care services. Lancet Reg Health Southeast Asia. 2025 Mar 28;35:100564. doi: 10.1016/j.lansea.2025.100564. eCollection 2025 Apr.

Reference Type: DERIVED

PMID: 40230446 (View on PubMed)

Mehrin SF, Hasan MI, Tofail F, Shiraji S, Ridout D, Grantham-McGregor S, Hamadani JD, Baker-Henningham H. Integrating a Group-Based, Early Childhood Parenting Intervention Into Primary Health Care Services in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Front Pediatr. 2022 Jun 10;10:886542. doi: 10.3389/fped.2022.886542. eCollection 2022.

Reference Type: DERIVED

PMID: 35783319 (View on PubMed)

Hamadani JD, Mehrin SF, Tofail F, Hasan MI, Huda SN, Baker-Henningham H, Ridout D, Grantham-McGregor S. Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial. Lancet Glob Health. 2019 Mar;7(3):e366-e375. doi: 10.1016/S2214-109X(18)30535-7.

Reference Type: DERIVED

PMID: 30784637 (View on PubMed)

Other Identifiers

PR-13099

Identifier Type: -

Identifier Source: org_study_id