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Development of Appetite Measuring Tool and Appetite Status of Stunted Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02839148
Enrollment
390
Registered
2016-07-20
Start date
2016-04-30
Completion date
2018-04-30
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Stunting

Keywords

Appetite, Stunting, Satiety, Children

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.

Interventions

DIETARY_SUPPLEMENTFood 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.

Sponsors

University of Washington
CollaboratorOTHER
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children4 months

Secondary

MeasureTime frame
Association of appetite score with growth and development child food intake15 months
Association of appetite score with growth and potential biomarkers of appetite15 months
Association of appetite score with growth and intestinal inflammation of the children15 months

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026