Child GrowthNCT04222998
Home-based Growth Charts in Indonesia
A study testing Home-based growth charts, Home visits for baseline surveys and Home visits for end line surveys in people with Child Growth, run by Boston University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 9 to 14 months
- Conditions the study is for
- Child Growth
- What is being tested?
- Home-based growth charts, Home visits for baseline surveys and Home visits for end line surveys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,487 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Mar 2022to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- -Caregivers with a cognitive disability
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
The Abdul Latif Jameel Poverty Action Lab Southeast Asia
Jakarta
About this study
Official title: Impact of Home-based Growth Charts on Child Linear Growth 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.
Read the 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.
- Conditions
- Child Growth
- Being tested
- Home-based growth charts, Home visits for baseline surveys, Home visits for end line surveys, Measurement of child's height-for-age and weight-for-age
- Keywords
- Home-based growth charts, Child nutrition, Growth faltering, Stunting, Indonesia
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based growth chartsOther
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 surveysOther
Households will be visited for baseline surveys.
Home visits for end line surveysOther
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-ageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Household receives the home-based growth chart Receives: Other: Home-based growth charts; Other: Home visits for baseline surveys; Other: Home visits for end line surveys; Other: Measurement of child's height-for-age and weight-for-age |
| Control group | Active comparator | Household does not receive the home-based growth chart Receives: Other: Home visits for baseline surveys; Other: Home visits for end line surveys; Other: Measurement of child's height-for-age and weight-for-age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Child stunting
Child stunting is defined as height for age z-score (HAZ) < -2
Measured: 12 months
Secondary outcomes (2)
Child weight for age z-score (WAZ)
Weight data will be converted to weight for age z-score (WAZ) using WHO growth standards.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start14 Mar 2022
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child GrowthStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- The Abdul Latif Jameel Poverty Action Lab Southeast Asia, Department of Foregin Affairs and Trade, Australia
- Responsible party
- Sponsor
- Investigators
- Peter C Rockers, ScD, MPH, Principal investigator, BU School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222998
- Sponsor's protocol ID
- H-39613
- Other IDs
- 73494
- Status last verified
- Aug 2024
- First submitted
- 7 Jan 2020
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Home-based Growth Charts on Child Linear Growth in Indonesia
- ClinicalTrials.gov ID
- NCT04222998
- Acronym / sponsor ID
- H-39613
- Conditions
- Child Growth
- Keywords
- Home-based growth charts, Child nutrition, Growth faltering, Stunting, Indonesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,487 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- The Abdul Latif Jameel Poverty Action Lab Southeast Asia, Department of Foregin Affairs and Trade, Australia
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Home-based growth charts, Other: Home visits for baseline surveys, Other: Home visits for end line surveys, Other: Measurement of child's height-for-age and weight-for-ageHousehold receives the home-based growth chart |
| Control group | Active comparator | Other: Home visits for baseline surveys, Other: Home visits for end line surveys, Other: Measurement of child's height-for-age and weight-for-ageHousehold does not receive the home-based growth chart |
Who may qualify
- Ages
- 9 to 14 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -Caregivers with a cognitive disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based growth chartsThe 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. | Other | Intervention group |
| Home visits for baseline surveysHouseholds will be visited for baseline surveys. | Other | Control group, Intervention group |
| Home visits for end line surveysHouseholds will be revisited after 1 year of grace-period for baseline end line surveys. | Other | Control group, Intervention group |
| Measurement of child's height-for-age and weight-for-ageThe 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. | Other | Control group, Intervention group |
Primary outcome
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.
Child stunting
Time frame: 12 months
Child stunting is defined as height for age z-score (HAZ) < -2
2 secondary outcomes
Child weight for age z-score (WAZ)
Time frame: 12 months
Early child development (ECD)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter C Rockers, ScD, MPH principal investigator
BU School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based growth charts, Home visits for baseline surveys and Home visits for end line surveys in people with Child Growth, run by Boston University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child height for age z-score (HAZ) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.