Community-based Program to Treat Childhood Obesity
|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
|Condition or disease||Intervention/treatment|
|Childhood Obesity||Behavioral: JOIN Intervention|
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
- Physical activity
- Stimulus control
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Behavioral: JOIN Intervention
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374646
|United States, Rhode Island|
|YMCA of Greater Providence|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Deneen Votja, MD||UnitedHealth Group|