We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Childhood Prevention of Childhood Overweight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00896545
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : July 25, 2011
Sponsor:
Information provided by:
Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Overweight Behavioral: 5-keys counseling Behavioral: Lifestyle counseling Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of an Early Intervention for the Prevention of Childhood Obesity
Study Start Date : November 2008
Primary Completion Date : May 2011
Study Completion Date : May 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Parental control of feeding [ Time Frame: 5-weeks ]
    Assessed by Questionnaire pre and post treatment.


Secondary Outcome Measures :
  1. Daily patterns of child and family meals [ Time Frame: 1-week ]
    Assessed by questionnaire pre and post treatment



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
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


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): 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

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
First Posted: May 11, 2009    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms