Interventions to Control Obesity in Community Colleges (CDC WAY to Health)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
WEB + Environment
WEB + Cash Incentive for Weight Loss
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, worksite
Eligibility Criteria
Inclusion Criteria:
- BMI greater than or equal to 25
Exclusion Criteria:
- Type I diabetes
- Pregnant or lactating
- Had a recent weight loss of 20 pounds or more
- Currently taking weight loss medication or unwilling to stop
- Undergone or scheduled weight loss surgery
- Experienced a malignancy requiring chemotherapy or radiation in the past five years
- No internet access
- Answered "yes" to the PAR-Q items and did not return a required physician's consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Other
Other
Arm Label
Environment / Usual Care
WEB+ Environment
WEB + Cash Incentive for Weight Loss
Arm Description
Web-based weight loss program (WEB) + Environment - Participants have access to a proven Web-based weight loss program with weekly lessons focused on lifestyle behavior changes
Web-based Weight Loss Program + Cash Incentive for Weight Loss - participants have access to a proven web-based weight loss program plus they are paid cash based on the percent weight lost at 12 months compared to baseline.
Outcomes
Primary Outcome Measures
weight change
participants weight change will be analyzed at 12 months compared to baseline
Secondary Outcome Measures
moderate vigorous physical activity
total calories
percent body fat
fruit/veg intake
absenteeism
quality of life
medical expenditures
Full Information
NCT ID
NCT01282775
First Posted
January 20, 2011
Last Updated
January 21, 2011
Sponsor
University of North Carolina, Chapel Hill
Collaborators
RTI International
1. Study Identification
Unique Protocol Identification Number
NCT01282775
Brief Title
Interventions to Control Obesity in Community Colleges (CDC WAY to Health)
Official Title
Interventions to Control Obesity in Community Colleges
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
RTI International
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
CDC WAY to Health is a three year, group-randomized weight loss intervention study where approximately 1020 overweight/obese employees nested within 17 community colleges are randomly assigned to receive one of three promising, state-of-the-art, theory-linked interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and intervention; employee is the unit of analysis. Follow-up weigh-in assessments are conducted at 3, 6, and 12 months.
Detailed Description
Despite the fact that obesity is at epidemic proportions and costs US employers an estimated $78.5 billion annually; national data indicate that less than 25% of employers are offering disease management programs to address obesity. Effective weight loss programs that are adaptable to busy work environments and maintain employee interest are needed, but few rigorous tests of these programs have been attempted.
In collaboration with the North Carolina Community College System, NC Blue Cross Blue Shield, and the State Health Plan for Teachers and State Employees, this three year group-randomized weight loss intervention studies approximately 1020 overweight/obese employees nested within 17 community colleges. Campuses are randomly assigned to receive one of three promising, state-of-the-art, theory-linked interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and intervention; employee is the unit of analysis. Follow-up weigh-in assessments are completed at 3, 6, and 12 months.
After formative research in Year 1 to adapt interventions for community college employees, the effects of these interventions are rigorously tested on 12-month weight loss (primary outcome). Most secondary outcomes (weight loss behaviors, moderate-vigorous physical activity; total calories, percent body fat, fruit/vegetable intake, absenteeism, productivity, medical expenditures, and quality of life) are assessed at baseline, 6 and 12 months; along with potential mediators/moderators of weight loss outcomes. Process tracking data measures fidelity, dose delivered/received and acceptability/satisfaction with the interventions. Extensive cost- and cost-effectiveness analysis, including return on investment, is undertaken. If proven effective, this strong partnership between community colleges, the State Health Plan, and the research team, will help guide program adoption and institutionalization/dissemination throughout the community college campus system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
overweight, obesity, worksite
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1029 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Environment / Usual Care
Arm Type
No Intervention
Arm Title
WEB+ Environment
Arm Type
Other
Arm Description
Web-based weight loss program (WEB) + Environment - Participants have access to a proven Web-based weight loss program with weekly lessons focused on lifestyle behavior changes
Arm Title
WEB + Cash Incentive for Weight Loss
Arm Type
Other
Arm Description
Web-based Weight Loss Program + Cash Incentive for Weight Loss - participants have access to a proven web-based weight loss program plus they are paid cash based on the percent weight lost at 12 months compared to baseline.
Intervention Type
Behavioral
Intervention Name(s)
WEB + Environment
Other Intervention Name(s)
Web-based Weight Loss Program
Intervention Description
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Intervention Type
Behavioral
Intervention Name(s)
WEB + Cash Incentive for Weight Loss
Other Intervention Name(s)
Web-based weight loss program + Cash incentive
Intervention Description
Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.
Primary Outcome Measure Information:
Title
weight change
Description
participants weight change will be analyzed at 12 months compared to baseline
Time Frame
3, 6, and 12 months
Secondary Outcome Measure Information:
Title
moderate vigorous physical activity
Time Frame
3, 6, and 12 months
Title
total calories
Time Frame
3, 6, and 12 months
Title
percent body fat
Time Frame
3, 6, and 12 months
Title
fruit/veg intake
Time Frame
3, 6, and 12 months
Title
absenteeism
Time Frame
3, 6, and 12 months
Title
quality of life
Time Frame
3, 6, and 12 months
Title
medical expenditures
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI greater than or equal to 25
Exclusion Criteria:
Type I diabetes
Pregnant or lactating
Had a recent weight loss of 20 pounds or more
Currently taking weight loss medication or unwilling to stop
Undergone or scheduled weight loss surgery
Experienced a malignancy requiring chemotherapy or radiation in the past five years
No internet access
Answered "yes" to the PAR-Q items and did not return a required physician's consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Linnan, ScD, CHES
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Interventions to Control Obesity in Community Colleges (CDC WAY to Health)
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