Impact of Life-size Growth Charts on Understanding of Stunting

May 4, 2021 updated by: Merry Fitzpatrick, Tufts University

Budikadidi: Making Stunting Visible Trial

Randomized control trial testing whether exposure to a wall hanging (growth mat) enabling parents to physically compare their children's height against the World Health Organization (WHO) standards for height-for-age in combination with normal messaging on stunting increases parents' understanding and retention of those messages. Both intervention and control groups will receive messages about stunting over a 3-month period, but the intervention group will also be exposed to the growth mats during the 3-month intervention period. Parents in both groups will be tested post intervention on the messages about stunting and scores will be compared.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is embedded within a development program implemented by a consortium led by Catholic Relief Services. The program aims to improve child nutrition, in part, through behavior change messaging. Parents have difficulty understanding that stunting is a problem because the high prevalence (57%) means the entire population curve has shifted to the left - a stunted child appears normal when compared to others in the community.

Through previous work, we have designed a wall-hanging like a life-size, color coded growth chart. Using 2 stage sampling, with parents clustered in neighbor groups, neighbor groups have been randomly assigned to intervention or control. Both groups will receive standard lessons on stunting while only the intervention group will have the growth mats incorporated into the lessons. After 3 months of exposure to the lessons, parents will be tested on their understanding of the key lesson points. Scores between groups will be tested for statistical differences. Qualitative focus groups throughout the intervention period will collect information on perception of the message delivery and the utility of the growth mats.

Study Type

Interventional

Enrollment (Actual)

1019

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • membership and regular participation in the selected neighbor groups

Exclusion Criteria:

  • extended absence from the village during the intervention period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lessons with Growth Mats
Participants, clustered by neighbor groups, will be given lessons on stunting. During the lessons the trainers will use the growth mats to demonstrate their points. In these villages, village-wide events will expose the full community to the messages in combination to the mats.
see arm/group descriptions for description of intervention
NO_INTERVENTION: Lessons without Mats
Participants, clustered by neighbor groups, will be given lessons on stunting without the aid of the growth mats. In these villages, village-wide events will expose the full community to the messages without the aid of the mats.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding of key messages on stunting
Time Frame: after 3 months of exposure to the lessons
there are multiple key points in the lessons on stunting accompanying the mats. Interviews will test the level of understanding for each key message, combining them into a composite score. Both individual and composite scores will be compared.
after 3 months of exposure to the lessons

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to change behavior
Time Frame: after 3 months of exposure to the lessons
Interviews will measure self-reported willingness to practice the recommended behaviors to reduce stunting
after 3 months of exposure to the lessons

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Merry Fitzpatrick, PhD, Tufts University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2020

Primary Completion (ACTUAL)

March 10, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (ACTUAL)

October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw, non-identifiable results from the questions related to understanding of stunting will be available in .xlsx format from the PI.

IPD Sharing Time Frame

after publication of results, estimated October-December 2021

IPD Sharing Access Criteria

Researchers seeking to use the data to inform other studies, students conducting class-based research, or practitioners seeking to inform behavior change programs to prevent stunting can receive the raw data and supporting information upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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