A School Nurse-Delivered Intervention for Overweight and At Risk Adolescents
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Counseling Intervention
Information Intervention
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Adolescents, Youth, School health, Randomized controlled trial, Intervention study
Eligibility Criteria
Inclusion Criteria:
- enrolled in grades 9 through 12
- BMI equal or greater than 85th percentile
- able to understand and participate in study protocol
- able to provide informed assent (adolescent) and consent (parent)
- student and at least one parent English speaking
Exclusion Criteria:
- unable/unwilling to provide informed assent (adolescent)and consent (parent)
- planning to move out of the area within the next 6 months
- medical condition that precludes adherence to study dietary recommendations
- diagnosis of a serious psychiatric illness within the past 5 years
- genetic or endocrine causes of obesity
- developmental delay that would prevent participation in intervention or measurements
- prescribed medications associated with weight gain
- morbidly obese, defined as 300 pounds oe greater
Sites / Locations
- University of Massachusetts Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CI
II
Arm Description
Six 30-minute individual student-centered counseling sessions based on the 5A approach to assist adolescents in making changes in their diet and level of physical activity delivered by school nurses over 2 months (weekly in month 1, biweekly in month 2)
Six individual sessions with the school nurse over 2 months to check weight and behavior changes and provide a series of six pamphlets on weight and weight management
Outcomes
Primary Outcome Measures
BMI
Secondary Outcome Measures
Adherence to self-management behaviors (diet, physical activity, and sedentary behavior)
Full Information
NCT ID
NCT00682188
First Posted
May 20, 2008
Last Updated
March 12, 2014
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT00682188
Brief Title
A School Nurse-Delivered Intervention for Overweight and At Risk Adolescents
Official Title
A School Nurse-Delivered Intervention for Overweight and At Risk Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (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
Overweight in adolescents has nearly tripled in the past two decades and has serious physical and psychosocial consequences, both during adolescence and into adulthood. School nurses have tremendous potential to prevent and treat overweight in this population, as over 95% of adolescents have contact with the school health system each year and school nurses have the credibility and skills to provide guidance regarding weight, diet and physical activity. The goals of the proposed exploratory study are to adapt an innovative, theory-based school nurse-delivered counseling intervention model used effectively for smoking cessation for the treatment of adolescent overweight, and test its feasibility and potential efficacy in reducing BMI, improving diet, increasing physical activity and decreasing sedentary behavior. If the results of this exploratory study prove promising, the efficacy of the intervention will be evaluated in a large scale randomized controlled trial.
Detailed Description
Overweight in adolescents has nearly tripled in the past two decades and has serious physical and psychosocial consequences, both during adolescence and into adulthood. School nurses have tremendous potential to identify, prevent, and treat overweight in this population, as over 95% of children and adolescents have contact with the school health system each year and school nurses have the credibility and skills to provide guidance regarding weight, diet and physical activity. However, to our knowledge there have been no randomized controlled school-based trials that have utilized the school nurse to deliver weight-related intervention to adolescents. In a RCT conducted by the investigators, we found a school nurse-delivered smoking cessation intervention was successful in assisting adolescent smokers to quit, being both feasible to deliver in the school health setting and very well received by adolescents.
This two-year exploratory study will adapt this innovative, theory-based school nurse-delivered intervention model for the treatment of adolescent overweight, and test its feasibility and potential efficacy in reducing BMI, improving diet, increasing physical activity and decreasing sedentary behavior. The content of the intervention will be based on current clinical guidelines for the treatment of overweight in adolescents and Social Cognitive Theory (SCT), employing cognitive-behavioral techniques to facilitate changes in a set of very focused self-management behaviors: diet (at least 5 fruits vegetables a day; avoid soda and sugar sweetened drinks), physical activity (at least 1 hour on most days), and sedentary behavior (less than 2 hours of TV, video, and computer time a day). Four high schools in Massachusetts will be pair matched on demographics, school size, and percent low income and randomly assigned to one of two conditions: (1) Counseling Intervention (CI) consisting of six 30-minute individual student-centered counseling sessions delivered by school nurses over 2 months (weekly in month 1, biweekly in month 2); or (2) Information Intervention (II) attention-control comparison condition consisting of six individual sessions with the school nurse over 2 months (weekly in month 1, biweekly in month 2) to check status regarding weight and behavior changes and deliver a series of standardized pamphlets on weight and weight management. Adolescents (n=84) enrolled in grades 9 through 12 at-risk for overweight (body mass index (BMI) between the 85th and 94th percentile for age and gender) or overweight (BMI at or greater than the 95th percentile) will be recruited from the four schools. Assessments will be conducted at baseline and at 3-and 6-month follow-up. Should the results of this exploratory study prove promising the efficacy of the intervention will be evaluated in a large scale RCT. If found to be effective, such a school nurse-delivered intervention for adolescent overweight would have tremendous potential for wide-scale dissemination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Adolescents, Youth, School health, Randomized controlled trial, Intervention study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CI
Arm Type
Experimental
Arm Description
Six 30-minute individual student-centered counseling sessions based on the 5A approach to assist adolescents in making changes in their diet and level of physical activity delivered by school nurses over 2 months (weekly in month 1, biweekly in month 2)
Arm Title
II
Arm Type
Active Comparator
Arm Description
Six individual sessions with the school nurse over 2 months to check weight and behavior changes and provide a series of six pamphlets on weight and weight management
Intervention Type
Behavioral
Intervention Name(s)
Counseling Intervention
Intervention Description
Six 30-minute individual student-centered counseling sessions based on the 5A approach to assist adolescents in making changes in their diet and level of physical activity delivered by school nurses over 2 months (weekly in month 1, biweekly in month 2)
Intervention Type
Behavioral
Intervention Name(s)
Information Intervention
Intervention Description
Six individual sessions with the school nurse over 2 months to check weight and behavioral changes and provide a series of six pamphlets on weight and weight management
Primary Outcome Measure Information:
Title
BMI
Time Frame
3- and 6-month post baseline
Secondary Outcome Measure Information:
Title
Adherence to self-management behaviors (diet, physical activity, and sedentary behavior)
Time Frame
3- and 6-month post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
enrolled in grades 9 through 12
BMI equal or greater than 85th percentile
able to understand and participate in study protocol
able to provide informed assent (adolescent) and consent (parent)
student and at least one parent English speaking
Exclusion Criteria:
unable/unwilling to provide informed assent (adolescent)and consent (parent)
planning to move out of the area within the next 6 months
medical condition that precludes adherence to study dietary recommendations
diagnosis of a serious psychiatric illness within the past 5 years
genetic or endocrine causes of obesity
developmental delay that would prevent participation in intervention or measurements
prescribed medications associated with weight gain
morbidly obese, defined as 300 pounds oe greater
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
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A School Nurse-Delivered Intervention for Overweight and At Risk Adolescents
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