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Community-based Program to Treat Childhood Obesity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by UnitedHealth Group.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374646
First Posted: June 16, 2011
Last Update Posted: July 4, 2011
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.
Information provided by:
UnitedHealth Group
  Purpose
This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.

Condition Intervention
Childhood Obesity Behavioral: JOIN Intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Community-based Program to Treat Childhood and Adolescent Obesity

Further study details as provided by UnitedHealth Group:

Primary Outcome Measures:
  • Change in weight and body mass index (BMI) in children and teens at 6 months [ Time Frame: 6 Months ]
    Assess the effects of a community based program on weight change in children ages 6-12 and teens ages 13-17. Assessments will occur at baseline, 3 and 6 months.


Secondary Outcome Measures:
  • Change in weight and BMI in parent/guardian/care giver at 6 months [ Time Frame: 6 months ]
    Assess the effects of a community based program on weight change in parent/guardian/care givers. Assessments will occur at baseline, 3 and 6 months.

  • Change in physical activity level in children and teens at 6 months [ Time Frame: 6 months ]
    Assess the effects of a community based program on physical activity level. Accelerometers will be used to access change at baseline, 3 and 6 months.

  • Changes in intake and sedentary behavior at 6 months [ Time Frame: 6 months ]
    Change in the number of sugar sweetened beverages consumed per day, hours per day on screen time (TV, video games, and computer), and quality of life at 6 months. Assessments will occur at baseline, 3 and 6 months.

  • Process Outcomes [ Time Frame: 6 Months ]
    Assess process outcomes measures, such as attendance and program satisfaction.


Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: JOIN Intervention
    Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.
Detailed Description:

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.

This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:

  • Parental involvement
  • Reduction in consumption of sugar sweetened beverages
  • Reduction of screen time
  • Self-monitoring
  • Physical activity
  • Stimulus control
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Children and teens between the ages of 6-17
  • BMI percentile ≥85
  • Participation of a parent/guardian

Exclusion Criteria:

  • Enrollment in another weight loss program or study
  • Diagnosis of type 1 or type 2 diabetes
  • Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
  • Medications (e.g., steroids) that affect weight or appetite
  • Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in 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): NCT01374646


Locations
United States, Rhode Island
YMCA of Greater Providence
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
UnitedHealth Group
Investigators
Principal Investigator: Deneen Votja, MD UnitedHealth Group
  More Information

Responsible Party: Dr. Deneen Vojta, UnitedHealth Group
ClinicalTrials.gov Identifier: NCT01374646     History of Changes
Other Study ID Numbers: JOIN2011 10-309
First Submitted: June 14, 2011
First Posted: June 16, 2011
Last Update Posted: July 4, 2011
Last Verified: January 2011

Keywords provided by UnitedHealth Group:
Childhood Obesity
Group Treatment
Community-based Programs

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