- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373670
Parent Mentors Using Positive Deviance in Childhood Obesity
March 11, 2016 updated by: The University of Texas Health Science Center at San Antonio
A feasibility study randomizing participants (parents of children age 2-5 years old) to receive either education or a parent mentor with the aim of improving health behaviors and improving their body mass index z-score.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
Texas
-
San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
-
-
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
2 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI z-score >2
Exclusion Criteria:
- Medical conditions or receiving medications affecting weight
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parent Mentor
Parent mentors using positive deviance findings to promote healthy behaviors
|
Using locally derived positive deviance findings to inform a behavioral intervention
|
|
Active Comparator: Education
Community health workers providing health education to promote healthy behaviors
|
Using standardized healthy behavior education (EatPlayGrow curriculum from NHLBI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body mass index z-score
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hollister EB, Foster BA, Dahdouli M, Ramirez J, Lai Z. Characterization of the Stool Microbiome in Hispanic Preschool Children by Weight Status and Time. Child Obes. 2018 Feb/Mar;14(2):122-130. doi: 10.1089/chi.2017.0122. Epub 2017 Oct 13.
- Foster BA, Aquino CA, Gil M, Gelfond JA, Hale DE. A Pilot Study of Parent Mentors for Early Childhood Obesity. J Obes. 2016;2016:2609504. doi: 10.1155/2016/2609504. Epub 2016 Jun 9.
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
January 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
February 20, 2015
First Submitted That Met QC Criteria
February 20, 2015
First Posted (Estimate)
February 27, 2015
Study Record Updates
Last Update Posted (Estimate)
March 14, 2016
Last Update Submitted That Met QC Criteria
March 11, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-470H
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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