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

Moderate and Severe Undernutrition Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208531
• Other study ID #: PR-13099
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: November 30, 2017

Study information

• Verified date: August 2018
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6400
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Moderate and Severe Undernutrition

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive, Language and Motor Composite Scores	The outcomes are measured on Bayley-III test.	12 months
Primary	Anthropometry multiple measures, viz. Weight, length/height and head circumference	Children's weight, length/height and head circumference will be measured using standard methods.	12 months
Primary	Behaviour	The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.	12 months
Secondary	Family Care Indicators	This outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.	12 months