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Development of Appetite Measuring Tool and Appetite Status of Stunted Children

Primary Purpose

Nutritional Stunting

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Food supplementation
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nutritional Stunting focused on measuring Appetite, Stunting, Satiety, Children

Eligibility Criteria

6 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 50 stunted children (LAZ<-2) aged 12-18 months
  • 50 non-stunted (LAZ≥-2) aged 12-18 months

Exclusion Criteria:

  • Severe acute malnutrition (SAM)
  • Chronic illness
  • Congenital anomaly/developmental delay/oromotor dysfunction

Sites / Locations

  • Icddr,B

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dietary supplementation

psychosocial stimulation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2016
Last Updated
February 10, 2022
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT02839148
Brief Title
Development of Appetite Measuring Tool and Appetite Status of Stunted Children
Official Title
Assessment of Maternal Perception Regarding Childhood Stunting and Development of a Tool to Assess Appetite in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Stunting
Keywords
Appetite, Stunting, Satiety, Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary supplementation
Arm Type
Experimental
Arm Description
In case of dietary supplementation, we will provide milk and egg 6 days a week for 3 months to stunted children.
Arm Title
psychosocial stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Food supplementation
Other Intervention Name(s)
Routine clinical care, psychosocial stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Association of appetite score with growth and development child food intake
Time Frame
15 months
Title
Association of appetite score with growth and potential biomarkers of appetite
Time Frame
15 months
Title
Association of appetite score with growth and intestinal inflammation of the children
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 50 stunted children (LAZ<-2) aged 12-18 months 50 non-stunted (LAZ≥-2) aged 12-18 months Exclusion Criteria: Severe acute malnutrition (SAM) Chronic illness Congenital anomaly/developmental delay/oromotor dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baitun Nahar, PhD
Organizational Affiliation
Associate Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icddr,B
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
if required we will share data with our expertise
Citations:
PubMed Identifier
34045689
Citation
Naila NN, Mahfuz M, Hossain M, Arndt M, Walson JL, Nahar B, Ahmed T. Improvement in appetite among stunted children receiving nutritional intervention in Bangladesh: results from a community-based study. Eur J Clin Nutr. 2021 Sep;75(9):1359-1367. doi: 10.1038/s41430-020-00843-9. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
31394828
Citation
Hossain M, Nahar B, Haque MA, Mondal D, Mahfuz M, Naila NN, Gazi MA, Hasan MM, Haque NMS, Haque R, Arndt MB, Walson JL, Ahmed T. Serum Adipokines, Growth Factors, and Cytokines Are Independently Associated with Stunting in Bangladeshi Children. Nutrients. 2019 Aug 7;11(8):1827. doi: 10.3390/nu11081827.
Results Reference
derived

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Development of Appetite Measuring Tool and Appetite Status of Stunted Children

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