Clinical trial NCT01282775: Interventions to Control Obesity in Community Colleges (CDC WAY to Health)
Official title: Interventions to Control Obesity in Community Colleges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Overweight
Obesity
Keywords: overweight
obesity
worksite
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: RTI International
First posted: 2011-01-25
Enrollment: 1029
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: weight change
timeFrame: 3, 6, and 12 months
Secondary outcomes:
measure: moderate vigorous physical activity
timeFrame: 3, 6, and 12 months
measure: total calories
timeFrame: 3, 6, and 12 months
measure: percent body fat
timeFrame: 3, 6, and 12 months
measure: fruit/veg intake
timeFrame: 3, 6, and 12 months
measure: absenteeism
timeFrame: 3, 6, and 12 months
measure: quality of life
timeFrame: 3, 6, and 12 months
measure: medical expenditures
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: UNC Chapel Hill
name: Laura A Linnan, ScD, CHES
role: PRINCIPAL_INVESTIGATOR
References: