- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01513343
Promoting The Self-Regulation Of Energy Intake (SEEDs)
June 30, 2022 updated by: Sheryl Hughes, Baylor College of Medicine
Promoting The Self-Regulation Of Energy Intake In Latino Preschoolers: A Family Focused Obesity Prevention Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The intervention program was developed and piloted.
Expected outcomes: At the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered (e.g., repeated presentation of new foods, involvement in food preparation) and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions).
Children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake.
At the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables).
All effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish.
Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in children's BMI percentiles by the 6- and 12-month follow-ups for the intervention group-especially for the top 25% of the BMI percentile range.
No parental BMI effects are expected.
Study Type
Interventional
Enrollment (Actual)
255
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Washington
-
Pullman, Washington, United States
- Thomas G. Power
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parent and child classes (prevention group)
Parent and child groups focused on self-regulation of eating
|
|
No Intervention: Treatment as usual (control group)
Treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's BMI Percentiles
Time Frame: 12-month follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental Feeding Behaviors
Time Frame: 12-month follow-up
|
Questionnaire data (parent-report).
Subscale scores from the Food Parenting Inventory and Feeding Knowledge Questionnaire were used to measure secondary outcomes.
All scales included response categories ranging from 1 to 5. Higher scores were considered better on the following subscales: repeated presentation of new foods; measured child portion sizes; child involvement in food preparation; feeding responsiveness; knowledge of best feeding practices; feeding efficacy.
Lower scores were considered better on the subscale of feeding misconceptions.
|
12-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sheryl O Hughes, PhD, Baylor College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
December 27, 2017
Study Completion (Actual)
December 27, 2017
Study Registration Dates
First Submitted
January 17, 2012
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 20, 2012
Study Record Updates
Last Update Posted (Actual)
May 15, 2023
Last Update Submitted That Met QC Criteria
June 30, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USDA 2011-68001-30009
- H-28013 (Other Identifier: Baylor College of Medicine)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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