- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04579328
Impact of Life-size Growth Charts on Understanding of Stunting
Budikadidi: Making Stunting Visible Trial
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
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see arm/group descriptions for description of intervention
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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.
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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
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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.
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after 3 months of exposure to the lessons
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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
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after 3 months of exposure to the lessons
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Merry Fitzpatrick, PhD, Tufts University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stunting
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Washington University School of MedicineKamuzu University of Health Sciences; Project Peanut Butter, MalawiCompletedNutritional StuntingMalawi
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International Centre for Diarrhoeal Disease Research...University of WashingtonCompletedNutritional StuntingBangladesh
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Indonesia UniversityWyeth nutrition indonesiaCompletedGrowth; Stunting, NutritionalIndonesia
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Danone Asia Pacific Holdings Pte, Ltd.KK Women's and Children's HospitalCompletedGrowth; Stunting, NutritionalSingapore
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University of South CarolinaHelen Keller InternationalCompleted
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International Centre for Diarrhoeal Disease Research...Department for International Development, United Kingdom; University of Sydney and other collaboratorsCompleted
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Swiss Federal Institute of TechnologyBRAC University; HarvestPlusCompletedZinc Deficiency | Growth; Stunting, NutritionalSwitzerland, Bangladesh
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University of CopenhagenUniversity of Aarhus; Arla FoodsCompletedGrowth Acceleration | Growth; Stunting, NutritionalDenmark
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Andalas UniversityIndonesia UniversityCompletedGastrointestinal Microbiome | Growth; Stunting, Nutritional | Immunoglobulin AIndonesia
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Danone Asia Pacific Holdings Pte, Ltd.KK Women's and Children's HospitalCompletedGrowth; Stunting, NutritionalSingapore
Clinical Trials on Exposure to Growth Mats
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University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Weight Gain | Food PreferencesUnited States
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AlyatecCompletedAllergic Rhinitis | Rhinoconjunctivitis | Allergy to PollenFrance
-
University of BaselCompletedMuscle Strength | Endurance Performance | Reaction TimeSwitzerland
-
University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
JAMK University Of Applied SciencesCompletedPhysiological Recovery | Psychological Recovery | Restorative ExperiencesFinland
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Stanford UniversityHarvard Pilgrim Health CareCompletedObesity | Dietary Habits | Weight Gain | Weight PrejudiceUnited States
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Fraunhofer-Institute of Toxicology and Experimental...CompletedHealthy | Chronic Obstructive Pulmonary DiseaseGermany
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University of North Carolina, Chapel HillDuke University; Stanford UniversityCompleted
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University of PennsylvaniaEnrolling by invitation
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Novosibirsk City Hospital #2Siberian Branch of the Russian Academy of Medical SciencesCompletedChronic Obstructive Pulmonary DiseaseRussian Federation