search
Back to results

Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children (TTS Bangladesh)

Primary Purpose

Moderate and Severe Undernutrition

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Psychosocial Stimulation and Nutritional Care
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Moderate and Severe Undernutrition focused on measuring Early Childhood Development (ECD), Psychosocial stimulation, Malnutrition, Bangladesh, Scaling up ECD

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Children with above exclusion criteria or those whose parents do not wish to sign the consent form will not be included in the evaluation sample but if they wish they will receive the stimulation.

Sites / Locations

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Psychosocial Stimulation and Nutritional Care

Arm Description

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

Outcomes

Primary Outcome Measures

Cognitive, Language and Motor Composite Scores
The outcomes are measured on Bayley-III test.
Anthropometry multiple measures, viz. Weight, length/height and head circumference
Children's weight, length/height and head circumference will be measured using standard methods.
Behaviour
The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.

Secondary Outcome Measures

Family Care Indicators
This outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.

Full Information

First Posted
August 3, 2014
Last Updated
March 3, 2019
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
search

1. Study Identification

Unique Protocol Identification Number
NCT02208531
Brief Title
Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children
Acronym
TTS Bangladesh
Official Title
Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Pilot two intervention methods and different delivery models of providing NC+PS to refine the intervention and identify any difficulties. Conduct a cluster randomized controlled trial (CRCT) of NC+PS on malnourished children. 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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate and Severe Undernutrition
Keywords
Early Childhood Development (ECD), Psychosocial stimulation, Malnutrition, Bangladesh, Scaling up ECD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Psychosocial Stimulation and Nutritional Care
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Psychosocial Stimulation and Nutritional Care
Intervention Description
Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.
Primary Outcome Measure Information:
Title
Cognitive, Language and Motor Composite Scores
Description
The outcomes are measured on Bayley-III test.
Time Frame
12 months
Title
Anthropometry multiple measures, viz. Weight, length/height and head circumference
Description
Children's weight, length/height and head circumference will be measured using standard methods.
Time Frame
12 months
Title
Behaviour
Description
The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Family Care Indicators
Description
This outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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 Children with above exclusion criteria or those whose parents do not wish to sign the consent form will not be included in the evaluation sample but if they wish they will receive the stimulation.
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
35783319
Citation
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.
Results Reference
derived
PubMed Identifier
30784637
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs