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Promoting The Self-Regulation Of Energy Intake (SEEDs)

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ClinicalTrials.gov Identifier: NCT01513343
Recruitment Status : Active, not recruiting
First Posted : January 20, 2012
Last Update Posted : January 1, 2018
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Behavioral: Parent and child groups focused on self-regulation of eating

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 and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style; 3)show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge. 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Promoting The Self-Regulation Of Energy Intake In African American And Latino Preschoolers: A Family Focused Obesity Prevention Program
Study Start Date : August 2014
Primary Completion Date : December 27, 2017
Estimated Study Completion Date : January 31, 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: Parent and child classes
Parent and child groups focused on self-regulation of eating
Behavioral: Parent and child groups focused on self-regulation of eating
No Intervention: Treatment as usual
Treatment as usual

Outcome Measures

Primary Outcome Measures :
  1. children's BMI percentiles [ Time Frame: up to 12-month follow-ups ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513343

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Thomas G. Power
Pullman, Washington, United States
Sponsors and Collaborators
Baylor College of Medicine
Washington State University
University of Colorado, Denver
Principal Investigator: Sheryl O Hughes, PhD Baylor College of Medicine
More Information

Responsible Party: Sheryl Hughes, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01513343     History of Changes
Other Study ID Numbers: USDA 2011-68001-30009
H-28013 ( Other Identifier: Baylor College of Medicine )
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms