Clinical trial NCT02839148: Development of Appetite Measuring Tool and Appetite Status of Stunted Children
Official title: Assessment of Maternal Perception Regarding Childhood Stunting and Development of a Tool to Assess Appetite in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Stunting
Keywords: Appetite, Stunting, Satiety, Children
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2016-07-20
Enrollment: 390
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Assessment of appetite score of stunted children aged 12-18 months compared to non-stunted children
timeFrame: 4 months
Secondary outcomes:
measure: Association of appetite score with growth and development child food intake
timeFrame: 15 months
measure: Association of appetite score with growth and potential biomarkers of appetite
timeFrame: 15 months
measure: Association of appetite score with growth and intestinal inflammation of the children
timeFrame: 15 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Icddr,B
Study officials:
affiliation: Associate Scientist
name: Baitun Nahar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.