NCT04222998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,487

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

2.4 years

First QC Date

January 7, 2020

Last Update Submit

August 28, 2024

Conditions

Keywords

Home-based growth chartsChild nutritionGrowth falteringStuntingIndonesia

Outcome Measures

Primary Outcomes (2)

  • 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

  • Child stunting

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

    12 months

Secondary Outcomes (2)

  • Child weight for age z-score (WAZ)

    12 months

  • Early child development (ECD)

    12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Household receives the home-based growth chart

Other: Home-based growth chartsOther: Home visits for baseline surveysOther: Home visits for end line surveysOther: Measurement of child's height-for-age and weight-for-age

Control group

ACTIVE COMPARATOR

Household does not receive the home-based growth chart

Other: Home visits for baseline surveysOther: Home visits for end line surveysOther: Measurement of child's height-for-age and weight-for-age

Interventions

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.

Intervention group

Households will be visited for baseline surveys.

Control groupIntervention group

Households will be revisited after 1 year of grace-period for baseline end line surveys.

Control groupIntervention group

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.

Control groupIntervention group

Eligibility Criteria

Age9 Months - 14 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Caregivers with a cognitive disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Abdul Latif Jameel Poverty Action Lab Southeast Asia

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Growth Disorders

Interventions

House CallsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Peter C Rockers, ScD, MPH

    BU School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Sub-villages ("dusun") will be randomly assigned to control and treatment group with around 740 caregiver-child (9-14 months) dyads in each group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 10, 2020

Study Start

March 14, 2022

Primary Completion

August 20, 2024

Study Completion

August 20, 2024

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations