Community-based Program to Treat Childhood Obesity

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effects of a Community-based Program to Treat Childhood and Adolescent Obesity

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: JOIN Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: JOIN Intervention|Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Process Outcomes | Assess process outcomes measures, such as attendance and program satisfaction. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood Obesity, Group Treatment, Community-based Programs