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

Interventions to Control Obesity in Community Colleges

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: WEB + Environment; Behavioral: WEB + Cash Incentive for Weight Loss

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.

• Study Type: Interventional
• Enrollment (Actual): 1029
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Environment / Usual Care
Other: 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 Names: Web-based Weight Loss Program
Other: 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 Names: 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 Names: Web-based weight loss program + Cash incentive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight change	participants weight change will be analyzed at 12 months compared to baseline	3, 6, and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: RTI International
• Investigators: Principal Investigator: Laura A Linnan, ScD, CHES, UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 21, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 25, 2011
• Last Update Submitted That Met QC Criteria: January 21, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: obesity; overweight; worksite
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 04-0509; DP000102 (Other Grant/Funding Number: Centers for Disease Control)