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Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children (TTS Bangladesh)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT02208531
First received: August 3, 2014
Last updated: August 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Moderate and Severe Undernutrition
Behavioral: Psychosocial Stimulation and Nutritional Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Cognitive, Language and Motor Composite Scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The outcomes are measured on Bayley-III test.

  • Anthropometry multiple measures, viz. Weight, length/height and head circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Children's weight, length/height and head circumference will be measured using standard methods.

  • Behaviour [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.


Secondary Outcome Measures:
  • Family Care Indicators [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.


Estimated Enrollment: 6400
Study Start Date: February 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: 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.
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.

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

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02208531

Contacts
Contact: Jena D Hamadani, PhD +880-2- 9827001-10 ext 2353 jena@icddrb.org
Contact: Fahmida Tofail, PhD +880-2- 9827001-10 ext 2350 ftofail@icddrb.org

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh Recruiting
Dhaka, Bangladesh, 1212
Contact: Jena D Hamadani       jena@icddrb.org   
Contact: Fahmida Tofail       ftofail@icddrb.org   
Principal Investigator: Jena D Hamadani, PhD         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02208531     History of Changes
Other Study ID Numbers: PR-13099
Study First Received: August 3, 2014
Last Updated: August 24, 2014
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Early Childhood Development (ECD)
Psychosocial stimulation
Malnutrition
Bangladesh
Scaling up ECD

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 27, 2014