Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans

Completed

Conditions: Obesity

Interventions: Other: 4 & 2 & 1 Plan
Other: 5 & 2 & 2 Plan

Registration Number: NCT02150837

Lead Sponsor: Medifast, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 372

Inclusion Criteria

Adult males and females, 18 years of age or older at the start of the weight loss program.
Subject has a BMI ≥ 25 kg/m2.
Subject started a weight management program at the MWCC location on or after January 1, 2012.
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.

Exclusion Criteria

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
4 & 2 & 1 Plan	4 & 2 & 1 Plan	MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss.
5 & 2 & 2 Plan	5 & 2 & 2 Plan	MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss.

Primary Outcome Measures

Name	Time	Method
Body Weight	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.).

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight	12 weeks	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).
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)	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).
Lean Mass	24 weeks	Lean mass expressed as an absolute change from baseline.
Fat Mass	24 weeks	Fat mass expressed as an absolute change from baseline.
Abdominal Circumference	24 weeks	Abdominal circumference expressed as an absolute change from baseline.
Waist Circumference	24 weeks	Waist circumference expressed as an absolute change from baseline.
Hip Circumference	24 weeks	Hip circumference expressed as an absolute change from baseline.
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)	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 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)	Pulse expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).
Blood Pressure Categorical	12 weeks	Blood pressure expressed as a categorical variable (normotensive, pre-hypertensive and hypertensive based on National Institute of Health Guidelines) with the percent of participants that improved (e.g. from hypertensive to pre-hypertensive or normal) their blood pressure category from baseline to 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)	Resting metabolic rate expressed as an absolute change from baseline to final weight loss visit (The average length of time from baseline to the final weight loss visit was 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)	Adherence will be assessed through documented use of meal replacements at each visit from baseline (The mean length of time from baseline to the final weight loss visit was 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)	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 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)	Change in body weight from baseline to final weight loss visit reported as absolute change. (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.)