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临床试验/NCT01662830
NCT01662830已完成不适用

Use of the Medifast Meal Replacement Program for Weight Loss in Obese Patients: A Restrospective Chart Review of Three Medifast Weight Control Centers (MWCC)

Medifast, Inc.0 个研究点目标入组 446 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
446
主要终点
Changes in weight

研究概览

简要总结

The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.

详细描述

Portion-controlled meal replacements by themselves have been shown to be an effective weight control strategy in overweight and obese individuals. The addition of medical supervision has been shown to result in greater weight loss than meal replacements alone. MWCC provides this added support through individual weekly counseling sessions. Thus, the investigators plan to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult males and females aged 18-70
  • Followed the Jump Start (5 & 1) Plan
  • Purchased a weight management program at the MWCC location in the last 3 years
  • Signed patient health information consent form

排除标准

  • On a plan other than the 5&1 (Jump Start)
  • Completed initial consultation but did not participate further
  • Program stopped due to client not getting baseline labs
  • Program stopped due for medical reasons unrelated to the 5 & 1 (Jump Start) plan
  • Currently an active participant at the MWCC
  • No signed patient health information consent form or written request to revoke consent

结局指标

主要结局

Changes in weight

时间窗: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)

Weight loss (in pounds and percent weight loss) at weeks 4, 12, 24 and at final weight loss visit (average of 19.6 weeks).

Changes in body composition

时间窗: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)

changes in lean muscle mass, body fat mass, and body fat percent at weeks 4, 12, 24, and final weight loss visit(average of 19.6 weeks).

次要结局

  • Compliance(weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks))
  • Retention rates(weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks))
  • Goal weight achievement(Final weight loss visit (average of 19.6 weeks))
  • Changes in abdominal circumference (inches)(weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks))
  • Maintenance of weight loss(Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program)
  • Changes in cardiovascular risk factors(weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks))

研究者

申办方类型
Industry
责任方
Sponsor

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