School Nurse Intervention and After School Exercise Program for Overweight Teens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lori Pbert, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01463124
First received: October 24, 2011
Last updated: March 12, 2014
Last verified: March 2014
  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:


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.


Enrollment: 126
Study Start Date: September 2012
Study Completion Date: July 2013
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: March 12, 2014
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 April 22, 2014