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Community-based Program to Treat Childhood Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by UnitedHealth Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
UnitedHealth Group
ClinicalTrials.gov Identifier:
NCT01374646
First received: June 14, 2011
Last updated: July 1, 2011
Last verified: January 2011

June 14, 2011
July 1, 2011
November 2010
August 2011   (final data collection date for primary outcome measure)
Change in weight and body mass index (BMI) in children and teens at 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
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.
Change in weight and BMI in children and teens at 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01374646 on ClinicalTrials.gov Archive Site
  • Change in weight and BMI in parent/guardian/care giver at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assess process outcomes measures, such as attendance and program satisfaction.
Same as current
Not Provided
Not Provided
 
Community-based Program to Treat Childhood Obesity
Effects of a Community-based Program to Treat Childhood and Adolescent Obesity

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.

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
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Childhood Obesity
Behavioral: JOIN Intervention
Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
January 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01374646
JOIN2011 10-309
No
Dr. Deneen Vojta, UnitedHealth Group
UnitedHealth Group
Not Provided
Principal Investigator: Deneen Votja, MD UnitedHealth Group
UnitedHealth Group
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP