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临床试验/NCT01282775
NCT01282775已完成早期 1 期

Interventions to Control Obesity in Community Colleges

University of North Carolina, Chapel Hill0 个研究点目标入组 1,029 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
1,029
主要终点
weight change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI greater than or equal to 25

排除标准

  • 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

结局指标

主要结局

weight change

时间窗: 3, 6, and 12 months

participants weight change will be analyzed at 12 months compared to baseline

次要结局

  • total calories(3, 6, and 12 months)
  • medical expenditures(12 months)
  • quality of life(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)
  • moderate vigorous physical activity(3, 6, and 12 months)

研究者

申办方类型
Other

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