School Nurse Intervention and After School Exercise Program for Overweight Teens

Study Overview
=================
Brief Summary
-----------------
Adolescent overweight and obesity have increased dramatically in the past several decades. High schools are well-positioned to deliver weight loss treatment to overweight and obese adolescents, as they have the facilities and staff to deliver a physical activity program, school nurses with the skills to provide counseling, and are easily accessible by adolescents. This exploratory study will test the feasibility and ability of a school-based intervention, consisting of school nurse counseling and a school-based exercise program, to reduce BMI and improve dietary quality, physical activity, and sedentary behaviors in overweight and obese adolescents. If effective, this could prove to be a cost-effective and relatively easy intervention to disseminate widely for significant public health impact.

Official Title
-----------------
School Nurse Intervention and After School Exercise Program for Overweight Teens

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Lookin' Good Feelin' Good
* Behavioral: Information attention-control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolled in grades 9 - 12 BMI > 85th percentile for age/sex able to understand and participate in the study able and willing to provide informed assent (adolescent) and consent (parent) English-speaking with at least one English-speaking parent Exclusion Criteria: planning to move out of the area within the next 8 months medical condition that precludes adherence to study dietary recommendations (e.g., pregnancy, Crohn's disease, ulcerative colitis) diagnosis of a serious psychiatric illness (e.g., psychiatric hospitalization, eating disorder, suicidal) within the past 5 years genetic or endocrine causes of obesity (e.g., pradi Willi, Cushing's Syndrome) developmental delay that would prevent participation in the intervention or measurements prescribed medications associated with weight gain (e.g.,oral steroids) morbidly obese, defined as weighing > 300 pounds

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lookin' Good Feelin' Good<br>Six 30-minute individual student-centered counseling sessions delivered by school nurses during the first two months followed by weekly weigh-ins and monthly visits over the subsequent 6 months, plus an exercise program in the school 3 times a week for the full eight months of the intervention. | Behavioral: Lookin' Good Feelin' Good<br>* Six 30-minute individual student-centered counseling sessions delivered by school nurses during the first two months followed by weekly weigh-ins and monthly visits over the subsequent 6 months, plus an exercise program in the school 3 times a week for the full eight months of the intervention.<br>|
| Active Comparator: Information attention-control<br>Six individual sessions with school nurse over the first two months followed by monthly visits over the remaining 6 months to check weight and behavior changes and provide a series of pamphlets on weight and weight management. | Behavioral: Information attention-control<br>* Six individual sessions with school nurse over the first two months followed by monthly visits over the remaining 6 months to check weight and behavior changes and provide a series of pamphlets on weight and weight management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | Lookin Good Feelin Good (LGFG) program participants will achieve greater reduction in BMI z-scores than Information attention control (IC) participants after one academic year (8 months) of intervention | One academic year (8 months) | 
| Participation in exercise program | LGFG participants will report greater than 90% adherence to intervention protocol by school nurses on Patient Exit Interview (PEI) checklists following each of the 6 visits and will attend at least 75% of the exercise sessions. | One academic year (8 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management | LGFG participants will report greater improvements in dietary quality, physical activity and sedentary behavior than IC participants at 8 month follow-up, as measured by 24-hour dietary recall (24HDR), accelerometers, and measures of specific diet, physical activity and sedentary behaviors targeted by the intervention. Improvements will mediate the relationship between condition and BMI. | One academic year (8 months) | 
| Physiologic outcomes | To evaluate the effect of the LGFG compared to IC condition on changes in secondary physiologic outcomes, including waist circumference, estimate of body fat, and blood pressure. | One academic year (8 months) | 
| Psychosocial outcomes | To evaluate the effect of the LGFG compared to the IC condition on changes in psychosocial outcomes including self-efficacy, quality of life, and depression. | One academic year (8 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
School Nurse, Overweight, Obesity, Counseling, Intervention, Exercise