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

Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02208531
Acronym
TTS Bangladesh
Enrollment
6400
Registered
2014-08-05
Start date
2014-02-28
Completion date
2017-11-30
Last updated
2019-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate and Severe Undernutrition

Keywords

Early Childhood Development (ECD), Psychosocial stimulation, Malnutrition, Bangladesh, Scaling up ECD

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.

Interventions

BEHAVIORALPsychosocial 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.

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Behaviour12 monthsThe outcome is measured using Wolke's behaviour ratings during the Bayley-III test.
Cognitive, Language and Motor Composite Scores12 monthsThe outcomes are measured on Bayley-III test.
Anthropometry multiple measures, viz. Weight, length/height and head circumference12 monthsChildren's weight, length/height and head circumference will be measured using standard methods.

Secondary

MeasureTime frameDescription
Family Care Indicators12 monthsThis outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026