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Community-based Program to Treat Childhood Obesity

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ClinicalTrials.gov Identifier: NCT01374646
Recruitment Status : Unknown
Verified January 2011 by UnitedHealth Group.
Recruitment status was:  Active, not recruiting
First Posted : June 16, 2011
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:
UnitedHealth Group

Brief Summary:
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 or disease Intervention/treatment
Childhood Obesity Behavioral: JOIN Intervention

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Study Start Date : November 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : January 2012

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.


Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

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



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

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

Responsible Party: Dr. Deneen Vojta, UnitedHealth Group
ClinicalTrials.gov Identifier: NCT01374646     History of Changes
Other Study ID Numbers: JOIN2011 10-309
First Posted: June 16, 2011    Key Record Dates
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