- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04222998
Home-based Growth Charts in Indonesia
Impact of Home-based Growth Charts on Child Linear Growth in Indonesia
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Jakarta, Indonesia
- The Abdul Latif Jameel Poverty Action Lab Southeast Asia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Household receives the home-based growth chart
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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.
Households will be visited for baseline surveys.
Households will be revisited after 1 year of grace-period for baseline end line surveys.
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.
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Active Comparator: Control group
Household does not receive the home-based growth chart
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Households will be visited for baseline surveys.
Households will be revisited after 1 year of grace-period for baseline end line surveys.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child height for age z-score (HAZ)
Time Frame: 12 months
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Height/length data will be converted to height for age z-score (HAZ) using WHO (World Health Organization) growth standards.
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12 months
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Child stunting
Time Frame: 12 months
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Child stunting is defined as height for age z-score (HAZ) < -2
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child weight for age z-score (WAZ)
Time Frame: 12 months
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Weight data will be converted to weight for age z-score (WAZ) using WHO growth standards.
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12 months
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Early child development (ECD)
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter C Rockers, ScD, MPH, BU School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-39613
- 73494 (Other Grant/Funding Number: Department of Foreign Affairs and Trade, Australia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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