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Interventions to Control Obesity in Community Colleges (CDC WAY to Health)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282775
First Posted: January 25, 2011
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
RTI International
Information provided by:
University of North Carolina, Chapel Hill
  Purpose
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.

Condition Intervention Phase
Overweight Obesity Behavioral: WEB + Environment Behavioral: WEB + Cash Incentive for Weight Loss Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventions to Control Obesity in Community Colleges

Resource links provided by NLM:


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

Primary Outcome Measures:
  • weight change [ Time Frame: 3, 6, and 12 months ]
    participants weight change will be analyzed at 12 months compared to baseline


Secondary Outcome Measures:
  • moderate vigorous physical activity [ Time Frame: 3, 6, and 12 months ]
  • total calories [ Time Frame: 3, 6, and 12 months ]
  • percent body fat [ Time Frame: 3, 6, and 12 months ]
  • fruit/veg intake [ Time Frame: 3, 6, and 12 months ]
  • absenteeism [ Time Frame: 3, 6, and 12 months ]
  • quality of life [ Time Frame: 3, 6, and 12 months ]
  • medical expenditures [ Time Frame: 12 months ]

Enrollment: 1029
Study Start Date: September 2005
Study Completion Date: March 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Environment / Usual Care
WEB+ Environment
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
Behavioral: WEB + Environment
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Other Name: Web-based Weight Loss Program
WEB + Cash Incentive for Weight Loss
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.
Behavioral: WEB + Environment
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Other Name: Web-based Weight Loss Program
Behavioral: WEB + Cash Incentive for Weight Loss
Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.
Other Name: Web-based weight loss program + Cash incentive

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282775


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

Responsible Party: Laura Linnan, ScD, CHES / Associate Professor / Principal Investigator, UNC Chapel Hill
ClinicalTrials.gov Identifier: NCT01282775     History of Changes
Other Study ID Numbers: 04-0509
DP000102 ( Other Grant/Funding Number: Centers for Disease Control )
First Submitted: January 20, 2011
First Posted: January 25, 2011
Last Update Posted: January 25, 2011
Last Verified: January 2011

Keywords provided by University of North Carolina, Chapel Hill:
overweight
obesity
worksite

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms