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Impact of Life-size Growth Charts on Understanding of Stunting

Primary Purpose

Stunting

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure to Growth Mats
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stunting focused on measuring stunting, height-for-age, behavior change, malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • membership and regular participation in the selected neighbor groups

Exclusion Criteria:

  • extended absence from the village during the intervention period

Sites / Locations

  • Tufts University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lessons with Growth Mats

Lessons without Mats

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Understanding of key messages on stunting
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.

Secondary Outcome Measures

Willingness to change behavior
Interviews will measure self-reported willingness to practice the recommended behaviors to reduce stunting

Full Information

First Posted
October 1, 2020
Last Updated
May 4, 2021
Sponsor
Tufts University
Collaborators
Catholic Relief Services, United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04579328
Brief Title
Impact of Life-size Growth Charts on Understanding of Stunting
Official Title
Budikadidi: Making Stunting Visible Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Catholic Relief Services, United States Agency for International Development (USAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting
Keywords
stunting, height-for-age, behavior change, malnutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to intervention and control groups. At the end of a 3-month intervention, differences in comprehension of messages on stunting will be measured. Additionally, focus groups in the general community will collect information on perceptions of the messages and growth mats.
Masking
Outcomes Assessor
Masking Description
enumerators interviewing/testing the participants on their understanding of the messages will not know whether or not the participants have been exposed to the growth mats (intervention).
Allocation
Randomized
Enrollment
1019 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lessons with Growth Mats
Arm Type
Experimental
Arm Description
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.
Arm Title
Lessons without Mats
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure to Growth Mats
Intervention Description
see arm/group descriptions for description of intervention
Primary Outcome Measure Information:
Title
Understanding of key messages on stunting
Description
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.
Time Frame
after 3 months of exposure to the lessons
Secondary Outcome Measure Information:
Title
Willingness to change behavior
Description
Interviews will measure self-reported willingness to practice the recommended behaviors to reduce stunting
Time Frame
after 3 months of exposure to the lessons

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: membership and regular participation in the selected neighbor groups Exclusion Criteria: extended absence from the village during the intervention period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merry Fitzpatrick, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Impact of Life-size Growth Charts on Understanding of Stunting

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