Clinical trial NCT02208531: Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children
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
Overall status: COMPLETED
Phase: NA
Conditions: Moderate and Severe Undernutrition
Keywords: Early Childhood Development (ECD)
Psychosocial stimulation
Malnutrition
Bangladesh
Scaling up ECD
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 6400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Cognitive, Language and Motor Composite Scores
timeFrame: 12 months
measure: Anthropometry multiple measures, viz. Weight, length/height and head circumference
timeFrame: 12 months
measure: Behaviour
timeFrame: 12 months
Secondary outcomes:
measure: Family Care Indicators
timeFrame: 12 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
References:
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.
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.