- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330743
Parent Mentor Interventions for Early Childhood Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim is to test an intervention to disseminate and promote the adoption of positive deviance behaviors among parents of obese Hispanic children using peer mentors. This trial will evaluate the efficacy and feasibility of this approach in reducing adiposity among a high-risk population of children.
Our central hypothesis is that children randomized to the intervention with a parent mentor using positive deviance methods with have a greater reduction in adiposity as measured by body mass index (BMI) compared with a parent mentor using traditional education or a control receiving usual education.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97229
- OHSU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 2-5 years of age child, Hispanic ethnicity, attends the Head Start facility
Exclusion Criteria:
- any major medical disorder impairing growth or development
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
|
|
Placebo Comparator: Parent Mentor
|
Parent mentors will provide coaching based on the current guidelines around diet and physical activity
|
Active Comparator: Parent Mentor with Positive Deviance
|
Parent mentors will provide coaching based on findings from the positive deviance study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMIz
Time Frame: 6 months post-enrollment
|
standardized BMI for age and sex
|
6 months post-enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy
Time Frame: 6 months post-enrollment
|
Parenting self-efficacy around specific topics
|
6 months post-enrollment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Byron Foster, MD, MPH, Oregon Health and Science University
Publications and helpful links
General Publications
- Foster BA, Alvarez HO, Padilla T, Meyer JS. Longitudinal Examination of Hair Cortisol Concentrations and Weight Changes in Preschool-Aged Children of Latino Farmworkers. Child Obes. 2022 Aug 24. doi: 10.1089/chi.2022.0103. Online ahead of print.
- Foster BA, Weinstein K, Padilla T, Martinez C, Angeles-Ramos D. Growing Healthy Together: A Randomized Clinical Trial Using Parent Mentors for Early Childhood Obesity in Low-Income, Latino Families. Child Obes. 2022 Apr;18(3):168-177. doi: 10.1089/chi.2021.0165. Epub 2021 Oct 5.
- Foster BA, Weinstein K, Shannon J. Growing Healthy Together: protocol for a randomized clinical trial using parent mentors for early childhood obesity intervention in a Latino community. Trials. 2019 Apr 25;20(1):235. doi: 10.1186/s13063-019-3342-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- STUDY00017356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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