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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04579328
Other study ID # STUDY00000386
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date July 2021

Study information

Verified date May 2021
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1019
Est. completion date July 2021
Est. primary completion date March 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - membership and regular participation in the selected neighbor groups Exclusion Criteria: - extended absence from the village during the intervention period

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exposure to Growth Mats
see arm/group descriptions for description of intervention

Locations

Country Name City State
United States Tufts University Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Tufts University Catholic Relief Services, United States Agency for International Development (USAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Willingness to change behavior Interviews will measure self-reported willingness to practice the recommended behaviors to reduce stunting after 3 months of exposure to the lessons
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