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临床试验/NCT00373230
NCT00373230Unknown不适用

Treating Obesity and Its Consequences in Underserved Overweight Populations

Temple University2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2007年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
320
试验地点
2
主要终点
subject's weight

研究概览

简要总结

Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are the focus of this application, which will determine if a telemedicine system can help participants, who have undergone a weight loss program based in church and community centers, maintain their weight loss over a 1 year period. Telemedicine will provide support through self-monitoring, education, supervised chat room, bulletin board, and e-mail.

详细描述

Obesity has reached epidemic proportions with nearly two-thirds of the US population either overweight or obese. Ethnic minorities are disproportionately affected with 37% of African-American adults being obese. Obesity is also inversely related to socioeconomic status. In Pennsylvania, the prevalence of obesity increased from 14.7% in 1991 to 24.0% in 2002, and annual medical expenditures attributable to obesity are estimated at $4.2 billion; making Pennsylvania the 4th highest state in the country in terms of obesity-related costs. The prevalence of obesity is matched by it serious medical consequences including type 2 diabetes, hypertension, dyslipidemia, and atherosclerotic disease. The core pathogenetic factor underlying these conditions appears to be insulin resistance. Weight loss through diet and physical activity is the most desirable way to reduce insulin resistance (IR). Weight losses of 8-10% are associated with significant improvements in IR. While clinic-based weight loss programs at tertiary medical centers can produce clinically significant losses, the cost and location of these programs make them inaccessible to underserved populations (e.g., inner city African Americans and rural poor) who are most in need. Moreover, the most common outcome for weight loss treatments is weight regain. Thus, novel strategies that both improve weight loss maintenance and are accessible to those most in need are a priority for research and the focus of this application.

Based on our expertise in behavioral weight management and telemedicine, this study will determine if a telemedicine system can help participants, who have undergone a weight loss program based in church and community centers, maintain their weight loss over a 1 year period. Overweight and obese men and women (n = 400) will participate in a 16-week behavioral weight loss program in local churches and community centers. After 16 weeks, participants will be randomized to either an "In-person" follow-up group or to a "telemedicine" group for 1-year. The latter will provide support through self-monitoring, education, supervised chat room, bulletin board, and e-mail. Assessments of body weight, body composition and insulin sensitivity will be conducted at baseline, 16 and 68 weeks. Based on recent data, we predict greater maintenance of weight loss (and lower body weights) at 68 weeks in the Telemedicine group as compared to the "In person group".

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •27<BMI<45
  • •Able to walk

排除标准

  • •Diabetes on medications

研究组 & 干预措施

1

Experimental

Internet based telemedicine weight maintenance program

干预措施: telemedicine (Behavioral)

2

Active Comparator

In person weight maintenance monthly consultations

干预措施: telemedicine (Behavioral)

结局指标

主要结局

subject's weight

时间窗: 3 and 15 months

次要结局

  • Use of telemedicine system(over 12 months)
  • blood lipids(3 and 15 months)
  • blood glucose(3 and 15 months)
  • A1c(3 and 15 months)
  • Insulin(3 and 15 months)
  • blood pressure(3 and 15 months)
  • Oral Glucose Tolerance(3 and 15 months)

研究者

申办方类型
Other

研究点 (2)

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