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

This study has been completed.
Sponsor:
Collaborator:
RTI International
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01282775
First received: January 20, 2011
Last updated: January 21, 2011
Last verified: January 2011
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • total calories [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • percent body fat [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • fruit/veg intake [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • absenteeism [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • medical expenditures [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: January 20, 2011
Last Updated: January 21, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014