Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children
Condition: Moderate and Severe Undernutrition
MeSH terms: Malnutrition
Study type: Interventional

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.
    

Intervention name(s): Psychosocial Stimulation and Nutritional Care
Intervention type(s): Behavioral
Intervention description(s): Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Early Childhood Development (ECD); Psychosocial stimulation; Malnutrition; Bangladesh; Scaling up ECD