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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Interventions to Control Obesity in Community Colleges

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: WEB + Environment
* Behavioral: WEB + Cash Incentive for Weight Loss


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Environment / Usual Care<br> | |
| Other: WEB+ Environment<br>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<br>* Participants receive weekly lessons via the Web along with additional tools for weight loss support<br>* Other names: Web-based Weight Loss Program;|
| Other: WEB + Cash Incentive for Weight Loss<br>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<br>* Participants receive weekly lessons via the Web along with additional tools for weight loss support<br>* Other names: Web-based Weight Loss Program;Behavioral: WEB + Cash Incentive for Weight Loss<br>* Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.<br>* Other names: Web-based weight loss program + Cash incentive;|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, worksite