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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03330743
Other study ID # STUDY00017356
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date September 1, 2020

Study information

Verified date April 2022
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this clinical trial is to identify the most effective strategy for intervention to change behaviors and affect weight status in obese children 2-5 years of age within the context of early childhood education centers.


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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Parent Mentor with Standard Education
Parent mentors will provide coaching based on the current guidelines around diet and physical activity
Parent Mentor with Positive Deviance
Parent mentors will provide coaching based on findings from the positive deviance study

Locations

Country Name City State
United States OHSU Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary BMIz standardized BMI for age and sex 6 months post-enrollment
Secondary Self-efficacy Parenting self-efficacy around specific topics 6 months post-enrollment
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