NCT02839148

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

February 11, 2022

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

June 29, 2016

Last Update Submit

February 10, 2022

Conditions

Nutritional Stunting

Keywords

Appetite, Stunting, Satiety, Children

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (3)

  • Association of appetite score with growth and development child food intake

    15 months

  • Association of appetite score with growth and potential biomarkers of appetite

    15 months

  • Association of appetite score with growth and intestinal inflammation of the children

    15 months

Study Arms (2)

Dietary supplementation

EXPERIMENTAL

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

psychosocial stimulation

EXPERIMENTAL

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

Interventions

Food supplementationDIETARY_SUPPLEMENT

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.

Also known as: Routine clinical care, psychosocial stimulation
Dietary supplementationpsychosocial stimulation

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icddr,B

Dhaka, Bangladesh

Location

Related Publications (2)

  • 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.

    PMID: 34045689DERIVED

  • 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.

    PMID: 31394828DERIVED

MeSH Terms

Conditions

Growth Disorders

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Baitun Nahar, PhD

    Associate Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 20, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

February 11, 2022

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

if required we will share data with our expertise

Locations

BA(1)