School Nurse Intervention and After School Exercise Program for Overweight Teens

Obesity Clinical Trial

Official title:

School Nurse Intervention and After School Exercise Program for Overweight Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463124
• Other study ID #: R21HL110208
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2011
• Last updated: March 12, 2014
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

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.
• 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.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No