A Retrospective Chart Review to Assess Weight Loss in Overweight and Obese Adults Using Either the 5 & 2 & 2 Meal Replacement Plan or the 4 & 2 & 1 Meal Replacement Plan at Medifast Weight Control Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
The purpose of this study is to retrospectively and systematically review records of overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for weight loss to gain a better understanding of the effectiveness of these programs. The study will describe demographics of this population, along with weight loss, anthropometrics, body composition and effects on available cardiovascular parameters. Adherence to the plans will also be examined.
The study hypothesis is that the 5 & 2 & 2 Meal Replacement Plan and the 4 & 2 & 1 Meal Replacement Plan are both effective programs for weight loss in overweight and obese adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males and females, 18 years of age or older at the start of the weight loss program.
- •Subject has a BMI ≥ 25 kg/m
- •Subject started a weight management program at the MWCC location on or after January 1,
- •Subject followed the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for at least the first two weeks of their weight loss phase while an active member of the MWCC.
- •Subject signed the Personal Health Information Consent Form.
排除标准
- •Subject was concurrently following another weight loss program other than the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan while on that respective plan.
- •Subject had documented use of prescription or over-the-counter weight loss pharmacotherapy (e.g., phentermine, Orlistat) concurrently with the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan.
- •Subject completed initial consultation but did not participate in any follow-up visits.
- •Subject is currently in the active weight loss phase of their program at the MWCC (Subjects in the transition or weight maintenance phases of their programs are eligible.)
- •Written request by subject to revoke consent to use health information is present in subject chart.
结局指标
主要结局
Body Weight
时间窗: 12 weeks
The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans). Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 \& 2 \& 2 Plan and 17.35 weeks for the 4 \& 2 \& 1 Plan.).
次要结局
- Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight(12 weeks)
- Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight(Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan))
- Lean Mass(24 weeks)
- Fat Mass(24 weeks)
- Abdominal Circumference(24 weeks)
- Waist Circumference(24 weeks)
- Hip Circumference(24 weeks)
- Blood Pressure(Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan))
- Pulse(Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan))
- Blood Pressure Categorical(12 weeks)
- Resting Metabolic Rate(Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan))
- Adherence(Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan))
- Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight(Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan))
- Body Weight(Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan))