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
Recruitment status was Active, not recruiting
Sponsor:
UnitedHealth Group
Information provided by:
UnitedHealth Group
ClinicalTrials.gov Identifier:
NCT01374646
First received: June 14, 2011
Last updated: July 1, 2011
Last verified: January 2011
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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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of a Community-based Program to Treat Childhood and Adolescent Obesity |
Resource links provided by NLM:
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 ] [ 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.
Secondary Outcome Measures:
- 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.
| 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:
Detailed Description:
-
Behavioral: JOIN Intervention
Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.
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| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
No publications provided
| Responsible Party: | Dr. Deneen Vojta, UnitedHealth Group |
| ClinicalTrials.gov Identifier: | NCT01374646 History of Changes |
| Other Study ID Numbers: | JOIN2011 10-309 |
| Study First Received: | June 14, 2011 |
| Last Updated: | July 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UnitedHealth Group:
|
Childhood Obesity Group Treatment Community-based Programs |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013