Development of Appetite Measuring Tool and Appetite Status of Stunted Children

Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh (Other)
Overall Status
Completed
CT.gov ID
NCT02839148
Collaborator
University of Washington (Other)
390
1
2
24
16.3

Study Details

Study Description

Brief Summary

This study will provide a tool for researchers to measure important outcomes in relation to trial of intervention to reduce or prevent stunting.

Hypothesis: We assume that appetite score will be associated with improvement in growth and development parameters of children given the nutrition and psychosocial stimulation intervention

Objectives:

To explore maternal perception regarding childhood stunting To develop and validate an appetite measuring tool To assess the appetite status of young children To examine the relationship between appetite score, growth and development, potential biomarkers of appetite, child food intake and intestinal inflammation of the children.

Methods: In the first phase, a qualitative study will be conducted to explore maternal perception regarding childhood stunting and to develop a tool- the "Early Childhood Appetite and Satiety Tool"(ECAST) using mixed method approach (qualitative and quantitative). In the second phase, a community-based trial will be conducted with 50 stunted children of aged 12-18 months, living in urban slums of Dhaka, and 50 age-sex matched control children (non-stunted).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Food supplementation
N/A

Detailed Description

The stunted children will receive an intervention package which includes food supplementation (FS) with one egg and 150 ml of whole milk supplementing the usual home diet, 6 days a week for 3 months; psychosocial stimulation (PS) for 6 months, and routine clinical care monthly for 6 months. The control children will receive routine clinical care but no FS and PS. Routine clinical care includes micronutrients powder, de-worming, health and nutrition education and immunization. All children will be assessed for appetite score (ECAST score) and anthropometry-at baseline then monthly for 6 months; food intake at baseline then monthly for 3 months, and cognitive development using Bayley Scales of Infant and Toddler Development, third version (Bayley-III) on enrolment and at 3 and 6 months of enrolment. Blood samples will be collected to examine gut hormones, complete blood count and haemoglobin percentage.

Stool samples will be collected for routine examination and stool biomarkers. Urine sample will be collected for screening urinary tract infection. All the specimens will be collected at baseline and at 3 and 6 months of enrollment.

Outcome measures/variables:
The primary outcome:

Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children.

The secondary outcomes are:

-Association of appetite score with growth and development with potential biomarkers of appetite with child food intake and intestinal inflammation of the children.

Study Design

Study Type:
Interventional
Actual Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of Maternal Perception Regarding Childhood Stunting and Development of a Tool to Assess Appetite in Children
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dietary supplementation

In case of dietary supplementation, we will provide milk and egg 6 days a week for 3 months to stunted children.

Dietary Supplement: Food supplementation
Arm 1 will be given food supplementation (FS), psychosocial stimulation (PS) and routine clinical care will be given and arm will be provided only with routine clinical care. The control children will receive routine clinical care but no FS or PS.
Other Names:
  • Routine clinical care, psychosocial stimulation
  • Experimental: psychosocial stimulation

    In case of psychosocial stimulation, we well provide PS weekly for first month, fortnightly for 2nd and 3rd months and then monthly for next 3 months. The total number of visits will be 11 over a period of 6 months.

    Dietary Supplement: Food supplementation
    Arm 1 will be given food supplementation (FS), psychosocial stimulation (PS) and routine clinical care will be given and arm will be provided only with routine clinical care. The control children will receive routine clinical care but no FS or PS.
    Other Names:
  • Routine clinical care, psychosocial stimulation
  • Outcome Measures

    Primary Outcome Measures

    1. Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children [4 months]

    Secondary Outcome Measures

    1. Association of appetite score with growth and development child food intake [15 months]

    2. Association of appetite score with growth and potential biomarkers of appetite [15 months]

    3. Association of appetite score with growth and intestinal inflammation of the children [15 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 50 stunted children (LAZ<-2) aged 12-18 months

    • 50 non-stunted (LAZā‰„-2) aged 12-18 months

    Exclusion Criteria:
    • Severe acute malnutrition (SAM)

    • Chronic illness

    • Congenital anomaly/developmental delay/oromotor dysfunction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Icddr,B Dhaka Bangladesh

    Sponsors and Collaborators

    • International Centre for Diarrhoeal Disease Research, Bangladesh
    • University of Washington

    Investigators

    • Principal Investigator: Baitun Nahar, PhD, Associate Scientist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    International Centre for Diarrhoeal Disease Research, Bangladesh
    ClinicalTrials.gov Identifier:
    NCT02839148
    Other Study ID Numbers:
    • PR-16005
    First Posted:
    Jul 20, 2016
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2022