Clinical trial NCT04222998: Home-based Growth Charts in Indonesia
Official title: Impact of Home-based Growth Charts on Child Linear Growth in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Growth
Keywords: Home-based growth charts
Child nutrition
Growth faltering
Stunting
Indonesia
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: The Abdul Latif Jameel Poverty Action Lab Southeast Asia
name: Department of Foregin Affairs and Trade, Australia
First posted: 2020-01-10
Enrollment: 1487
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sub-villages ("dusun") will be randomly assigned to control and treatment group with around 740 caregiver-child (9-14 months) dyads in each group.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Child height for age z-score (HAZ)
timeFrame: 12 months
measure: Child stunting
timeFrame: 12 months
Secondary outcomes:
measure: Child weight for age z-score (WAZ)
timeFrame: 12 months
measure: Early child development (ECD)
timeFrame: 12 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: The Abdul Latif Jameel Poverty Action Lab Southeast Asia
Study officials:
affiliation: BU School of Public Health
name: Peter C Rockers, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: