Adolescents Committed to Nutrition and Physical Activity

Study Overview
=================
Brief Summary
-----------------
Community based participatory research principles will be used to create, implement and evaluate a culturally relevant and age-appropriate obesity intervention for adolescents who are overweight or obese. The intervention will be implemented through school-based health centers (SBHC) and will include clinical encounters with SBHC providers, use of Motivational Enhancement Therapy to help overweight/obese adolescents adopt healthier behaviors, and use of a community advisory council to develop obesity risk reduction strategies that will be delivered by print and digital video disc (DVD) media. To test efficacy of the ACTION intervention, overweight/obese adolescents will be recruited to either the intervention condition or the usual care condition. Students will have pre- and post- intervention measurements to assess if adolescents in the intervention condition will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students in the usual care condition.

Official Title
-----------------
Adolescents Committed to Improvement of Nutrition and Physical Activity (ACTION)

Conditions
-----------------
Overweight, Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Behavioral: ACTION
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than or equal to the 85th percentile in BMI in 9th through 11th grades at participating schools Exclusion Criteria: BMI greater than or equal to 40 previously diagnosed type 1 or type 2 diabetes blood pressure in the range of stage 2 hypertension medications that significantly interfere with weight

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ACTION | Behavioral: ACTION<br>* Overweight/obese adolescents enrolled in ACTION will meet with SBHC providers over a 6 month period in one school year. SBHC providers will use Motivational Enhancement Therapy to motivate overweight/obese adolescents to adopt strategies for improving nutrition and physical activity.<br>|
| Active Comparator: 2<br>Usual care | Behavioral: Usual care<br>* Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI percentile |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance |  | 6 months | 
| Lipids |  | 6 months | 
| Dietary intake |  | 6 months | 
| Blood pressure |  | 6 months | 
| Physical activity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Overweight, Obesity, Weight loss, Nutrition, Physical activity, Community-based participatory research, School-based, Primary Care, Motivational interviewing