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

University of North Carolina (UNC)

Status and phase: Completed; Early Phase 1

Conditions: Overweight; Obesity

Treatments: Behavioral: WEB + Cash Incentive for Weight Loss; Behavioral: WEB + Environment

Study type: Interventional

Funder types: Other

Identifiers

NCT01282775

DP000102 (Other Grant/Funding Number)

04-0509

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,029 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,029 participants in 3 patient groups

Environment / Usual Care

No Intervention group

WEB+ Environment

Other group

Description:

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

Treatment:

Behavioral: WEB + Environment

WEB + Cash Incentive for Weight Loss

Other group

Description:

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.

Treatment:

Behavioral: WEB + Environment

Behavioral: WEB + Cash Incentive for Weight Loss