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

October 24, 2011
March 12, 2014
September 2012
June 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01463124 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
School Nurse Intervention and After School Exercise Program for Overweight Teens
School Nurse Intervention and After School Exercise Program for Overweight Teens

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Lookin' Good Feelin' Good
  • 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.
    Intervention: Behavioral: Information attention-control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
13 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01463124
R21HL110208
Yes
Lori Pbert, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Lori Pbert, PhD University of Massachusetts, Worcester
University of Massachusetts, Worcester
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP