School Nurse Intervention and After School Exercise Program for Overweight Teens - Full Text View

Purpose

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.

Condition	Intervention	Phase
Overweight Obesity	Behavioral: Lookin' Good Feelin' Good Behavioral: Information attention-control	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	School Nurse Intervention and After School Exercise Program for Overweight Teens

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Obesity

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:

Body Mass Index (BMI) [ Time Frame: One academic year (8 months) ] [ Designated as safety issue: No ]
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 [ Time Frame: One academic year (8 months) ] [ Designated as safety issue: No ]
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:

Self-management [ Time Frame: One academic year (8 months) ] [ Designated as safety issue: No ]
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 [ Time Frame: One academic year (8 months) ] [ Designated as safety issue: No ]
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 [ Time Frame: One academic year (8 months) ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	136
Study Start Date:	September 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

Eligibility

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463124

Locations

United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655

Sponsors and Collaborators

University of Massachusetts, Worcester

Investigators

Principal Investigator:

Lori Pbert, PhD

University of Massachusetts, Worcester

More Information

No publications provided

Responsible Party:	Lori Pbert, Professor of Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:	NCT01463124 History of Changes
Other Study ID Numbers:	R21HL110208
Study First Received:	October 24, 2011
Last Updated:	May 7, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:

School Nurse
Overweight
Obesity

Counseling
Intervention
Exercise

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013