Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program

Study Overview
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Brief Summary
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Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1 Although several pediatric weight management programs are available, access to these programs may not always be possible. The proposed study will be an ongoing research program with approximately 40 children ages 12-18 years enrolled into the study over a year. All study participants will participate in a baseline evaluation which will include body composition measures, aerobic testing, as well as nutrition and physical activity questionnaires. Study participants will be assigned to the clinic-based group. The clinic- based group will participate in a 12-week multi-disciplinary weight management program. All study participants will then participate in a 12-week follow-up evaluation similar to the baseline visit. New participants will be enrolled every 12 weeks. Every 12 weeks, active participants (those that have completed a minimum of 12 weeks) will have the option to continue in the program or, discontinue their active participation in the program and enroll into the maintenance phase which will consist of measures only every 12 weeks. The objective of the proposed study includes examining the efficacy of the clinic-based, multi-disciplinary, pediatric weight management program.

Official Title
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Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program

Conditions
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Body Weight Changes

Intervention / Treatment
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* Behavioral: multidisciplinary, behavior modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phone screening Approval to participate in a weight management program from the child's pediatrician Children between the ages of 12 and 18 years Children overweight (>85th-<95th BMI percentile) or obese (>95th BMI percentile) Exclusion Criteria: Children with evidence of significant cardiovascular disease or cardiac arrhythmias Children with liver disease Children on chronic use of medications including diuretics, steroids and adrenergic-stimulating agents Children with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions Children with evidence of family and/or medical neglect or physical, mental or sexual child abuse

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multidisciplinary, behavior modification<br> | Behavioral: multidisciplinary, behavior modification<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | Body weight will be measured at baseline and at 12-weeks. Mean percentage weight change will be assessed following the 12-week intervention. | 12 weeks |