ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity

Study Overview
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Brief Summary
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Using a previously created weight management program for adolescents, the intervention will be implemented through school-based health centers (SBHC) and will be delivered by SBHC providers trained in Motivational Interviewing. Students at intervention school sites will be compared to students at control school sites. All students will have baseline, 1 year, and 2 year follow-up to assess if students in the intervention school sites will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students at control school sites.

Official Title
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ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: ACTION PAC
* Behavioral: Comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: enrolled in 9th or 10th grade at participating schools Exclusion Criteria: blood pressure in the range of stage 2 hypertension previously diagnosed type 1 or type 2 diabetes use of corticosteroids, antipsychotics, metformin, antihypertensive medications, and medications used for dyslipidemia inability to perform moderate to vigorous physical activity not ambulatory a score of 20 or more on Eating Attitudes Test (EAT)-26 screening measure developmental disorders that affect weight or ability to understand the study procedures or counseling

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTION PAC<br> | Behavioral: ACTION PAC<br>* Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.<br>|
| Active Comparator: Comparison<br> | Behavioral: Comparison<br>* Annual BMI results will not be discussed with participants in comparison schools; however, a letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of overweight/obesity by BMI percentile |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI z score in those who are overweight/obese |  | Baseline to 2 years | 
| Change in insulin resistance as measured by the homeostatic model assessment insulin resistance index |  | Baseline to 2 years | 
| Change in minutes of moderate to vigorous physical activity by accelerometry |  | Baseline to 2 years | 
| Change in dietary intake by use of a food screener questionnaire |  | Baseline to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, School-based, Primary care, Motivational Interviewing, Adolescent, Overweight, Obesity, Weight loss, Nutrition