Back to resultsParent Mentor Interventions for Early Childhood Obesity
Primary Purpose
Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Mentor with Standard Education
Parent Mentor with Positive Deviance
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
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
Sites / Locations
- OHSU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Placebo Comparator
Active Comparator
Arm Label
Usual care
Parent Mentor
Parent Mentor with Positive Deviance
Arm Description
Outcomes
Primary Outcome Measures
BMIz
standardized BMI for age and sex
Secondary Outcome Measures
Self-efficacy
Parenting self-efficacy around specific topics
Full Information
NCT ID
NCT03330743
First Posted
October 31, 2017
Last Updated
April 28, 2022
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT03330743
Brief Title
Parent Mentor Interventions for Early Childhood Obesity
Official Title
Parent Mentor Interventions for Early Childhood Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Parent Mentor
Arm Type
Placebo Comparator
Arm Title
Parent Mentor with Positive Deviance
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Parent Mentor with Standard Education
Intervention Description
Parent mentors will provide coaching based on the current guidelines around diet and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Parent Mentor with Positive Deviance
Intervention Description
Parent mentors will provide coaching based on findings from the positive deviance study
Primary Outcome Measure Information:
Title
BMIz
Description
standardized BMI for age and sex
Time Frame
6 months post-enrollment
Secondary Outcome Measure Information:
Title
Self-efficacy
Description
Parenting self-efficacy around specific topics
Time Frame
6 months post-enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron Foster, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36036733
Citation
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. 2023 Sep;19(6):399-407. doi: 10.1089/chi.2022.0103. Epub 2022 Aug 24.
Results Reference
derived
PubMed Identifier
34613828
Citation
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.
Results Reference
derived
PubMed Identifier
31023345
Citation
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.
Results Reference
derived
Learn more about this trial
Parent Mentor Interventions for Early Childhood Obesity
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