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Early Childhood Prevention of Childhood Overweight

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00896545
First received: May 7, 2009
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

You are invited to participate in a research study to understand more about childhood obesity and how to prevent it. We hope to learn how families influence each others eating habits.


Condition Intervention Phase
Overweight
 Behavioral: 5-keys counseling
Behavioral: Lifestyle counseling
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development of an Early Intervention for the Prevention of Childhood Obesity

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Parental control of feeding [ Time Frame: 5-weeks ] [ Designated as safety issue: No ]
    Assessed by Questionnaire pre and post treatment.


Secondary Outcome Measures:
  • Daily patterns of child and family meals [ Time Frame: 1-week ] [ Designated as safety issue: No ]
    Assessed by questionnaire pre and post treatment


Estimated Enrollment: 100
Study Start Date: November 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-keys feeding program
Counseling in small groups aimed at enhancing children's self control over eating
 Behavioral: 5-keys counseling
5-session small group intervention
Behavioral: Lifestyle counseling
5-session small group behavioral intervention
Active Comparator: Healthy lifestyle counseling
Counseling in small groups aimed at achieving healthy eating patterns aimed at both the family and young children
 Behavioral: Lifestyle counseling
5-session small group behavioral intervention

Detailed Description:

This study aims to understand more about childhood obesity and how to prevent it. Two different methods of prevention will be tested and participants will be allocated at random to one of these methods. The investigators hope to learn how families influence each others eating habits.

Participants in this study will attend a series of five classes, once a week for five weeks, on the topic of child feeding. The aim of the classes is to learn how to feed your child so as to prevent future eating and weight problems. The research component includes filling out some surveys before classes begin and at the end of the last class. Classes are small and interactive so that parents have a chance to voice concerns and get feedback.

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • One or both parents with BMI > or = to 27.5
  • Healthy child ages 2-4 years

Exclusion criteria.

- Inadequate understanding of the English language

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896545

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: William Stewart Agras Stanford University
  More Information

No publications provided

Responsible Party: William Stewart Agras, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00896545     History of Changes
Other Study ID Numbers: SU-04072009-2158
Study First Received: May 7, 2009
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013