Promoting The Self-Regulation Of Energy Intake (SEEDs)

This study is not yet open for participant recruitment.
Verified January 2012 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: January 19, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Obesity
Behavioral: family education and counseling

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: 660
Study Start Date: February 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Parent groups focused on self-regulation of caloric intake
Behavioral: family education and counseling
Parents will be taught to use more child-centered feeding, be more authoritative in their feeding style, and recognize and acknowledge child cues of fullness. Children will be taught to pay attention to their fullness cues.
Active Comparator: Control
Parent groups focused on food safety
Behavioral: family education and counseling
Parents will be taught to use more child-centered feeding, be more authoritative in their feeding style, and recognize and acknowledge child cues of fullness. Children will be taught to pay attention to their fullness cues.

Detailed Description:

The current intervention currently is being 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, both parents and children (especially children) are expected to receive higher scores on the Healthy Eating Index and 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
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: January 19, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014