Development of Appetite Measuring Tool and Appetite Status of Stunted Children

International Centre for Diarrhoeal Disease Research (icddr,b)

Status: Completed

Conditions: Nutritional Stunting

Treatments: Dietary Supplement: Food supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02839148

PR-16005

Details and patient eligibility

About

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).

Full 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.

Enrollment: 390 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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390 participants in 2 patient groups

Dietary supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Food supplementation

psychosocial stimulation

Experimental group

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.

Treatment:

Dietary Supplement: Food supplementation