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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014