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Promoting The Self-Regulation Of Energy Intake (SEEDs)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Baylor College of Medicine
Sponsor:
Collaborators:
Washington State University
University of Colorado, Denver
Information provided by (Responsible Party):
Sheryl Hughes, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01513343
First received: January 17, 2012
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Promoting The Self-Regulation Of Energy Intake In African American And Latino Preschoolers: A Family Focused Obesity Prevention Program

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • children's BMI percentiles [ Time Frame: up to 12-month follow-ups ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: August 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513343

Contacts
Contact: Sheryl O Hughes, PhD 713-798-7017 shughes@bcm.tmc.edu

Locations
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Sheryl O Hughes, PhD    713-798-7017    shughes@bcm.tmc.edu   
Principal Investigator: Sheryl O Hughes, PhD         
Sponsors and Collaborators
Baylor College of Medicine
Washington State University
University of Colorado, Denver
Investigators
Principal Investigator: Sheryl O Hughes, PhD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Sheryl Hughes, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01513343     History of Changes
Other Study ID Numbers: USDA 2006-55215-16696
Study First Received: January 17, 2012
Last Updated: August 13, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014