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
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: JOIN Intervention||Not Applicable|
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.
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
|United States, Rhode Island|
|YMCA of Greater Providence|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Deneen Votja, MD||UnitedHealth Group|