Moderate and Severe Undernutrition Clinical Trial
Official title:
Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh
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.
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.
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