NCT01513343

Brief Summary

The goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
2.5 years until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2017

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

May 15, 2023

Completed
Last Updated

May 15, 2023

Status Verified

June 1, 2022

Enrollment Period

3.4 years

First QC Date

January 17, 2012

Results QC Date

March 9, 2022

Last Update Submit

June 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Children's BMI Percentiles

    Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to \<85th percentile), overweight (≥85th to \<95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards.

    12-month follow-up

Secondary Outcomes (1)

  • Parental Feeding Behaviors

    12-month follow-up

Study Arms (2)

Parent and child classes (prevention group)

EXPERIMENTAL

Parent and child groups focused on self-regulation of eating

Behavioral: Parent and child groups focused on self-regulation of eating

Treatment as usual (control group)

NO INTERVENTION

Treatment as usual

Interventions

Parent and child classes (prevention group)

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents whose children attend Head Start with the sample of children equally split on gender and ethnicity,
  • with representation from ages 3 to 6 years.

You may not qualify if:

  • Parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Thomas G. Power

Pullman, Washington, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Sheryl O. Hughes, Associate Professor
Organization
Baylor College of Medicine

Study Officials

  • Sheryl O Hughes, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 20, 2012

Study Start

August 1, 2014

Primary Completion

December 27, 2017

Study Completion

December 27, 2017

Last Updated

May 15, 2023

Results First Posted

May 15, 2023

Record last verified: 2022-06

Locations