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Completed

NCT Number: NCT02839148

Development of Appetite Measuring Tool and Appetite Status of Stunted Children

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).

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Key information

Conditions

Nutritional Stunting Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icddr,B

Dhaka, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food supplementation

Dietary 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.

Other names: Routine clinical care, psychosocial stimulation

Primary outcomes

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

    Time frame: 4 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Collaborators

  • University of Washington

Registry information

Official study title

Assessment of Maternal Perception Regarding Childhood Stunting and Development of a Tool to Assess Appetite in Children

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2016
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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