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Development of Appetite Measuring Tool and Appetite Status of Stunted Children

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ClinicalTrials.gov Identifier: NCT02839148
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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
Nutritional Stunting Dietary Supplement: Food supplementation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Routine clinical care, psychosocial stimulation




Primary Outcome Measures :
  1. Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Association of appetite score with growth and development child food intake [ Time Frame: 15 months ]
  2. Association of appetite score with growth and potential biomarkers of appetite [ Time Frame: 15 months ]
  3. Association of appetite score with growth and intestinal inflammation of the children [ Time Frame: 15 months ]


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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839148


Contacts
Contact: Nurun Naila, MPH 01853555777 ext 2313 nurun.nahar@icddrb.org
Contact: Baitun Nahar, PhD 01715567108 ext 2336 baitun@icddrb.org

Locations
Bangladesh
Icddr,B Recruiting
Dhaka, Bangladesh
Contact: Nurun Naila, MPH    01853555777 ext 2313    nurun.nahar@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Washington
Investigators
Principal Investigator: Baitun Nahar, PhD Associate Scientist

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02839148     History of Changes
Other Study ID Numbers: PR16005
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: if required we will share data with our expertise

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Appetite, Stunting, Satiety, Children

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes