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Completed

NCT Number: NCT04222998

Home-based Growth Charts in Indonesia

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.

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Key information

Conditions

Child Growth Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

9 month–14 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Abdul Latif Jameel Poverty Action Lab Southeast Asia

Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based growth charts

Other

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

Other

Households will be visited for baseline surveys.

Home visits for end line surveys

Other

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

Other

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.

Primary outcomes

  1. Child height for age z-score (HAZ)

    Time frame: 12 months

    Height/length data will be converted to height for age z-score (HAZ) using WHO (World Health Organization) growth standards.

  2. Child stunting

    Time frame: 12 months

    Child stunting is defined as height for age z-score (HAZ) < -2

Secondary outcomes

  1. Child weight for age z-score (WAZ)

    Time frame: 12 months

    Weight data will be converted to weight for age z-score (WAZ) using WHO growth standards.

  2. Early child development (ECD)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Department of Foregin Affairs and Trade, Australia
  • The Abdul Latif Jameel Poverty Action Lab Southeast Asia

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2020
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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