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

Obesity Clinical Trial

Official title:

Interventions to Control Obesity in Community Colleges

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282775
• Other study ID #: 04-0509
• Secondary ID: DP000102
• Status: Completed
• Phase: Phase 0
• First received: January 20, 2011
• Last updated: January 21, 2011
• Start date: September 2005
• Est. completion date: March 2007

Study information

• Verified date: January 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1029
• Est. completion date: March 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• WEB + Environment
Participants receive weekly lessons via the Web along with additional tools for weight loss support
• WEB + Cash Incentive for Weight Loss
Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	RTI International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight change	participants weight change will be analyzed at 12 months compared to baseline	3, 6, and 12 months	No
Secondary	moderate vigorous physical activity		3, 6, and 12 months	No
Secondary	total calories		3, 6, and 12 months	No
Secondary	percent body fat		3, 6, and 12 months	No
Secondary	fruit/veg intake		3, 6, and 12 months	No
Secondary	absenteeism		3, 6, and 12 months	No
Secondary	quality of life		3, 6, and 12 months	No
Secondary	medical expenditures		12 months	No