Comparison of Two Workplace-Sponsored Obesity Prevention Programs

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00481715
First received: May 31, 2007
Last updated: January 26, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Weight Loss
Behavioral: Web-Based Weight Loss Program
Behavioral: Cash Incentive Weight Loss Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventions to Control Obesity in Colleges

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Weight loss [ Time Frame: Measured at Mo 3,6, 12, 18 mo; powered at 12 mo measure ] [ Designated as safety issue: No ]

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 [ Time Frame: Measured at Mo 3, 6, 12 and 18 mo ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1020
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Web-based weight loss program
Behavioral: Web-Based Weight Loss Program
Participants will take part in a Web-based weight loss program.
Experimental: 2
Cash incentive weight loss program
Behavioral: Cash Incentive Weight Loss Program
Participants will take part in a cash incentive weight loss program.
Experimental: 3
Web-based program plus the cash incentive program
Behavioral: Web-Based Weight Loss Program
Participants will take part in a Web-based weight loss program.
Behavioral: Cash Incentive Weight Loss Program
Participants will take part in a cash incentive weight loss program.
No Intervention: 4
No intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481715

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Laura A. Linnan, ScD, CHES University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Laura Linnan, ScD/Associate Professor, UNC Chapel Hill
ClinicalTrials.gov Identifier: NCT00481715     History of Changes
Other Study ID Numbers: 473, R01 HL080656-01A1
Study First Received: May 31, 2007
Last Updated: January 26, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Web-Based Weight Loss Program
Cash Incentive Weight Loss Program
North Carolina

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014