School Nurse Intervention and After School Exercise Program for Overweight Teens

Phase 2

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Lookin' Good Feelin' Good; Behavioral: Information attention-control

• Registration Number: NCT01463124
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-11-01
• Study Start: 2012-09
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lookin' Good Feelin' Good	Lookin' Good Feelin' Good	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.
Information attention-control	Information attention-control	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.

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	One academic year (8 months)	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
Participation in exercise program	One academic year (8 months)	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.

Secondary Outcome Measures

Name	Time	Method
Self-management	One academic year (8 months)	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.
Physiologic outcomes	One academic year (8 months)	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.
Psychosocial outcomes	One academic year (8 months)	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.

Trial Locations

Locations (1)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States