Back to resultsSchool Nurse Intervention and After School Exercise Program for Overweight Teens
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lookin' Good Feelin' Good
Information attention-control
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring School Nurse, Overweight, Obesity, Counseling, Intervention, Exercise
Eligibility 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
Sites / Locations
- University of Massachusetts Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lookin' Good Feelin' Good
Information attention-control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01463124
First Posted
October 24, 2011
Last Updated
March 12, 2014
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT01463124
Brief Title
School Nurse Intervention and After School Exercise Program for Overweight Teens
Official Title
School Nurse Intervention and After School Exercise Program for Overweight Teens
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
School Nurse, Overweight, Obesity, Counseling, Intervention, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lookin' Good Feelin' Good
Arm Type
Experimental
Arm Description
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.
Arm Title
Information attention-control
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Lookin' Good Feelin' Good
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Information attention-control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
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
Time Frame
One academic year (8 months)
Title
Participation in exercise program
Description
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.
Time Frame
One academic year (8 months)
Secondary Outcome Measure Information:
Title
Self-management
Description
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.
Time Frame
One academic year (8 months)
Title
Physiologic outcomes
Description
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.
Time Frame
One academic year (8 months)
Title
Psychosocial outcomes
Description
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.
Time Frame
One academic year (8 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Pbert, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Learn more about this trial
School Nurse Intervention and After School Exercise Program for Overweight Teens
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