Promoting The Self-Regulation Of Energy Intake
SEEDs
2 other identifiers
interventional
255
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Aug 2014
Typical duration for not_applicable obesity
2 active sites
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
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2017
CompletedResults Posted
Study results publicly available
May 15, 2023
CompletedMay 15, 2023
June 1, 2022
3.4 years
January 17, 2012
March 9, 2022
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)
EXPERIMENTALParent and child groups focused on self-regulation of eating
Treatment as usual (control group)
NO INTERVENTIONTreatment as usual
Interventions
Eligibility Criteria
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
- Baylor College of Medicinelead
- Washington State Universitycollaborator
- University of Colorado, Denvercollaborator
Study Sites (2)
Baylor College of Medicine
Houston, Texas, 77030, United States
Thomas G. Power
Pullman, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sheryl O. Hughes, Associate Professor
- Organization
- Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Sheryl O Hughes, PhD
Baylor College of Medicine
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