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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
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, worksite

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 20, 2011
    Last Updated
    January 21, 2011
    Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    RTI International
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    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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