Home-based Growth Charts in Indonesia

Child Growth Clinical Trial

Official title:

Impact of Home-based Growth Charts on Child Linear Growth in Indonesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04222998
• Other study ID #: H-39613
• Secondary ID: 73494
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators developed a home-based growth chart that offers a simple and inexpensive way for caregivers to have access to simple health and nutrition information guided by behavioural economics analysis as well as to track their child's linear growth, empowering them to act to improve their child's nutrition. Results from a pilot study conducted in rural Zambia suggest that growth charts installed in homes can increase awareness and reduce early-life growth deficits, particularly among children experiencing growth faltering. The main objective of this study is to assess the impact and cost-effectiveness of growth charts through a cluster-randomized trial in Indonesia. The primary outcome is child height-for-age z-score.

Description:

The study is divided into two phases. In the first phase, growth chart development activities will be conducted in two villages in each of Manggarai Timur and Trenggalek districts to ensure the chart design is compatible with the local context and chart information is understandable to caregivers. Focus group discussions (FGDs), key informant interviews (KIIs), and door-to-door user testing will be conducted in each village. Results from the FGDs and KIIs will inform a draft growth chart design that will then be user tested in 10 households in each village. Qualitative interviews will be conducted with each household approximately two weeks after chart installation to gather insights on the usability of the growth chart. The chart design will then be finalized for use in the second phase of the study.

In the second phase, 1,480 caregiver-child dyads will be recruited and enrolled in the study as part of a baseline survey. Dyads will be sampled using a two-stage procedure. 110 villages will be selected proportionate to national census population size. All sub-villages ("dusun") within selected villages will be randomly assigned into two groups: 1) Growth chart; and 2) Control. Eligible caregiver-child dyads with children between 9 and 14 months will be selected from each sub-village.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1487
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 14 Months

Eligibility

Inclusion Criteria:

• Caregivers must be 19 - 55 years old

• One child of either gender, 9-14 months old

• Caregiver can have other children

• Caregiver of any occupation and income level

• Live in Manggarai Timur and Trenggalek during inception

Exclusion Criteria:

-Caregivers with a cognitive disability

Related Conditions & MeSH terms

• Child Growth

Intervention

Other:
• Home-based growth charts
The growth chart contains simple information of nutritious food, health, and sanitation information at the top and height chart is located at the bottom where caregivers can measure their child's linear growth. Growth charts will be installed in intervention group homes just after the baseline survey.
• Home visits for baseline surveys
Households will be visited for baseline surveys.
• Home visits for end line surveys
Households will be revisited after 1 year of grace-period for baseline end line surveys.
• Measurement of child's height-for-age and weight-for-age
The child's height-for-age and weight-for-age will be measured for participating dyads at the time of the baseline and end line surveys.

Locations

Country	Name	City	State
Indonesia	The Abdul Latif Jameel Poverty Action Lab Southeast Asia	Jakarta

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Department of Foregin Affairs and Trade, Australia, The Abdul Latif Jameel Poverty Action Lab Southeast Asia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child height for age z-score (HAZ)	Height/length data will be converted to height for age z-score (HAZ) using WHO (World Health Organization) growth standards.	12 months
Primary	Child stunting	Child stunting is defined as height for age z-score (HAZ) < -2	12 months
Secondary	Child weight for age z-score (WAZ)	Weight data will be converted to weight for age z-score (WAZ) using WHO growth standards.	12 months
Secondary	Early child development (ECD)	ECD will be evaluated with the Caregiver Reported Early Childhood Development Instruments (CREDI) Long Form which assesses child cognitive, motor, language, and social-emotional development. It provides a global, population-level measure of ECD for children in the 0-3 age range. The long form has about 60 items coded as Yes=1, No=0 and Don't know=8. The CREDI Long Form creates domain-specific developmental scores.	12 months