NCT04579328

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,019

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

October 1, 2020

Last Update Submit

May 4, 2021

Conditions

Keywords

stuntingheight-for-agebehavior changemalnutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

    after 3 months of exposure to the lessons

Secondary Outcomes (1)

  • Willingness to change behavior

    after 3 months of exposure to the lessons

Study Arms (2)

Lessons with Growth Mats

EXPERIMENTAL

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.

Behavioral: Exposure to Growth Mats

Lessons without Mats

NO INTERVENTION

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.

Interventions

see arm/group descriptions for description of intervention

Lessons with Growth Mats

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • membership and regular participation in the selected neighbor groups

You may not qualify if:

  • extended absence from the village during the intervention period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Growth DisordersMalnutrition

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Merry Fitzpatrick, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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).
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 8, 2020

Study Start

October 15, 2020

Primary Completion

March 10, 2021

Study Completion

July 1, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
after publication of results, estimated October-December 2021
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.

Locations