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Comparison of Two Workplace-Sponsored Obesity Prevention Programs

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-Based Weight Loss Program
Cash Incentive Weight Loss Program
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 Weight Loss focused on measuring Web-Based Weight Loss Program, Cash Incentive Weight Loss Program, North Carolina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body mass index (BMI) greater than or equal to 25
  • Current FT employee and member of the State Health Plan in North Carolina

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Type 1 diabetes
  • Currently taking weight loss medication
  • Lacks internet access at work or home
  • Previous weight loss surgery or plans to have weight loss surgery
  • Answers "Yes" to any of the Physical Activity Readiness Questionnaire questions
  • Known history of stroke, coronary heart disease, or type 2 diabetes, or possesses a BMI of 42 or higher AND does not have a medical clearance from a physician

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    1

    2

    3

    4

    Arm Description

    Web-based weight loss program

    Cash incentive weight loss program

    Web-based program plus the cash incentive program

    No intervention

    Outcomes

    Primary Outcome Measures

    Weight loss

    Secondary Outcome Measures

    Percentage of body fat; moderate physical activity (PA); moderate/vigorous PA and step counts; total calories consumed; fruits and vegetables consumed; total and saturated fat consumed; overall eating behavior; health related quality of life
    Self-reported health; presenteeism; productivity/work limits; turnover/absenteeism; medical expenditures data; campus changes in the physical/social environment

    Full Information

    First Posted
    May 31, 2007
    Last Updated
    January 26, 2011
    Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00481715
    Brief Title
    Comparison of Two Workplace-Sponsored Obesity Prevention Programs
    Official Title
    Interventions to Control Obesity in Colleges
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Obesity has reached epidemic proportions in the United States with nearly 64% of American adults considered overweight or obese. Weight loss programs that take place at work have proven to be effective at promoting healthy lifestyles. The purpose of this study is to compare the effectiveness of a Web-based weight loss program versus a cash incentive weight loss program among employees at North Carolina universities and colleges.
    Detailed Description
    Obesity, which leads to higher rates of diabetes, cancer, and heart disease, is an increasingly important public health problem. Evidence suggests that the effects of poor diet and physical inactivity will soon overtake smoking as the leading cause of death. Obesity-attributable medical expenses account for 9.1% of the total annual medical expenditures in the United States, and may be as high as $78.5 billion. In North Carolina, obesity accounts for more than $2 billion annually in increased medical spending and nearly half of this total is financed through employer-provided health insurance. Weight loss programs that take place at work have demonstrated the ability to improve both employee health and the financial health of the company. However, few weight loss programs have been evaluated and implemented in the workplace. The purpose of this study is to compare the effectiveness of a Web-based weight loss program versus a cash incentive weight loss program among employees at universities and colleges in North Carolina. This study will enroll approximately 1200 employees from 12 universities and colleges in North Carolina. Each university or college will be randomly assigned to one of the following four groups: 1) a Web-based weight loss program, 2) a cash incentive weight loss program, 3) the Web-based program plus the cash incentive program, or 4) neither program. Participants in the Web-based weight loss program will take part in a weekly Web-based weight control program that is comprehensive, individually focused, self-directed, and includes both weight loss and weight gain prevention information. In the cash incentive program, participants will receive a cash payment if they lose a pre-determined amount of weight at each follow-up weigh in. At baseline and Months 3, 6, 12, and 18, all participants will be weighed, body fat measurements will occur, and information on physical activity levels, eating behaviors, quality of life, work productivity, and medical expenses will be collected. During this study, study researchers will also monitor changes that occur in the physical and social environment on campus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss
    Keywords
    Web-Based Weight Loss Program, Cash Incentive Weight Loss Program, North Carolina

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1020 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Web-based weight loss program
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Cash incentive weight loss program
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Web-based program plus the cash incentive program
    Arm Title
    4
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Web-Based Weight Loss Program
    Intervention Description
    Participants will take part in a Web-based weight loss program.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cash Incentive Weight Loss Program
    Intervention Description
    Participants will take part in a cash incentive weight loss program.
    Primary Outcome Measure Information:
    Title
    Weight loss
    Time Frame
    Measured at Mo 3,6, 12, 18 mo; powered at 12 mo measure
    Secondary Outcome Measure Information:
    Title
    Percentage of body fat; moderate physical activity (PA); moderate/vigorous PA and step counts; total calories consumed; fruits and vegetables consumed; total and saturated fat consumed; overall eating behavior; health related quality of life
    Time Frame
    Measured at Mo 3, 6, 12 and 18 mo
    Title
    Self-reported health; presenteeism; productivity/work limits; turnover/absenteeism; medical expenditures data; campus changes in the physical/social environment
    Time Frame
    Measured at Mo 3, 6, 12, 18 mo

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Body mass index (BMI) greater than or equal to 25 Current FT employee and member of the State Health Plan in North Carolina Exclusion Criteria: Pregnant or breastfeeding Type 1 diabetes Currently taking weight loss medication Lacks internet access at work or home Previous weight loss surgery or plans to have weight loss surgery Answers "Yes" to any of the Physical Activity Readiness Questionnaire questions Known history of stroke, coronary heart disease, or type 2 diabetes, or possesses a BMI of 42 or higher AND does not have a medical clearance from a physician
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura A. Linnan, ScD, CHES
    Organizational Affiliation
    University of North Carolina, Chapel Hill
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Two Workplace-Sponsored Obesity Prevention Programs

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