Childhood Obesity Clinical Trial
Official title:
Effects of a Community-based Program to Treat Childhood and Adolescent Obesity
| Verified date | June 2021 |
| Source | UnitedHealth Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 155 |
| Est. completion date | June 5, 2012 |
| Est. primary completion date | June 5, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | YMCA of Greater Providence | Providence | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| UnitedHealth Group |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in weight and body mass index (BMI) in children and teens at 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. | 6 Months | |
| Secondary | Change in weight and BMI in parent/guardian/care giver at 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. | 6 months | |
| Secondary | Change in physical activity level in children and teens at 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. | 6 months | |
| Secondary | Changes in intake and sedentary behavior at 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. | 6 months | |
| Secondary | Process Outcomes | Assess process outcomes measures, such as attendance and program satisfaction. | 6 Months |
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|---|---|---|---|
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