NCT03330743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

October 31, 2017

Last Update Submit

April 28, 2022

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

  • BMIz

    standardized BMI for age and sex

    6 months post-enrollment

Secondary Outcomes (1)

  • Self-efficacy

    6 months post-enrollment

Study Arms (3)

Usual care

NO INTERVENTION

Parent Mentor

PLACEBO COMPARATOR
Behavioral: Parent Mentor with Standard Education

Parent Mentor with Positive Deviance

ACTIVE COMPARATOR
Behavioral: Parent Mentor with Positive Deviance

Interventions

Parent Mentor with Standard EducationBEHAVIORAL

Parent mentors will provide coaching based on the current guidelines around diet and physical activity

Parent Mentor
Parent Mentor with Positive DevianceBEHAVIORAL

Parent mentors will provide coaching based on findings from the positive deviance study

Parent Mentor with Positive Deviance

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age child, Hispanic ethnicity, attends the Head Start facility

You may not qualify if:

  • any major medical disorder impairing growth or development

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU

Portland, Oregon, 97229, United States

Location

Related Publications (3)

  • 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.

    PMID: 36036733DERIVED

  • 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.

    PMID: 34613828DERIVED

  • 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.

    PMID: 31023345DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Byron Foster, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 6, 2017

Study Start

January 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

US(1)