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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Other: 5 & 2 & 2 Plan
* Other: 4 & 2 & 1 Plan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 5 & 2 & 2 Plan<br>MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. | Other: 5 & 2 & 2 Plan<br>* Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.<br>|
| 4 & 2 & 1 Plan<br>MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. | Other: 4 & 2 & 1 Plan<br>* Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | 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.). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight | 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). | 12 weeks | 
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 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). | 12 weeks | 
| Lean Mass | Lean mass expressed as an absolute change from baseline. | 12 weeks | 
| Fat Mass | Fat mass expressed as an absolute change from baseline. | 12 weeks | 
| Abdominal Circumference | Abdominal circumference expressed as an absolute change from baseline. | 12 weeks | 
| Waist Circumference | Waist circumference expressed as an absolute change from baseline. | 12 weeks | 
| Hip Circumference | Hip circumference expressed as an absolute change from baseline. | 12 weeks | 
| Blood Pressure | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 12 weeks | 
| Pulse | Pulse expressed as an absolute change from baseline. | 12 weeks | 
| Blood Pressure Categorical | 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. | 12 weeks | 
| Resting Metabolic Rate | 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.). | 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 | Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit. (Meal replacement adherence=average number of self-reported daily meal replacements through 12 weeks/nuber of prescribed meal replacements; Attendance adherence=number of visits/number of weeks on plan | 12 weeks | 
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 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). | 1 weeks | 
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 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). | 2 weeks | 
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 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). | 4 weeks | 
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 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). | 8 weeks | 
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 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). | 16 weeks | 
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 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). | 20 weeks | 
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 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). | 24 weeks | 
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 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.). | 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 10% of Baseline Body Weight | 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). | 1 weeks | 
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 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). | 2 weeks | 
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 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). | 4 weeks | 
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 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). | 8 weeks | 
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 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). | 16 weeks | 
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 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). | 20 weeks | 
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 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). | 24 weeks | 
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 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.). | 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 | Lean mass expressed as an absolute change from baseline. | 4 weeks | 
| Lean Mass | Lean mass expressed as an absolute change from baseline. | 8 weeks | 
| Lean Mass | Lean mass expressed as an absolute change from baseline. | 16 weeks | 
| Lean Mass | Lean mass expressed as an absolute change from baseline. | 20 weeks | 
| Lean Mass | Lean mass expressed as an absolute change from baseline. | 24 weeks | 
| Fat Mass | Fat mass expressed as an absolute change from baseline. | 4 weeks | 
| Fat Mass | Fat mass expressed as an absolute change from baseline. | 8 weeks | 
| Fat Mass | Fat mass expressed as an absolute change from baseline. | 16 weeks | 
| Fat Mass | Fat mass expressed as an absolute change from baseline. | 20 weeks | 
| Abdominal Circumference | Abdominal circumference expressed as an absolute change from baseline. | 4 weeks | 
| Abdominal Circumference | Abdominal circumference expressed as an absolute change from baseline. | 8 weeks | 
| Abdominal Circumference | Abdominal circumference expressed as an absolute change from baseline. | 16 weeks | 
| Abdominal Circumference | Abdominal circumference expressed as an absolute change from baseline. | 20 weeks | 
| Abdominal Circumference | Abdominal circumference expressed as an absolute change from baseline. | 24 weeks | 
| Waist Circumference | Waist circumference expressed as an absolute from baseline. | 4 weeks | 
| Waist Circumference | Waist circumference expressed as an absolute change from baseline. | 8 weeks | 
| Waist Circumference | Waist circumference expressed as an absolute change from baseline. | 16 weeks | 
| Waist Circumference | Waist circumference expressed as an absolute change from baseline. | 20 weeks | 
| Waist Circumference | Waist circumference expressed as an absolute change from baseline. | 24 weeks | 
| Hip Circumference | Hip circumference expressed as an absolute change from baseline. | 4 weeks | 
| Hip Circumference | Hip circumference expressed as an absolute change from baseline. | 8 weeks | 
| Hip Circumference | Hip circumference expressed as an absolute change from baseline. | 16 weeks | 
| Hip Circumference | Hip circumference expressed as an absolute change from baseline. | 20 weeks | 
| Hip Circumference | Hip circumference expressed as an absolute change from baseline. | 24 weeks | 
| Blood Pressure | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 1 weeks | 
| Blood Pressure | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 2 weeks | 
| Blood Pressure | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 4 weeks | 
| Blood Pressure | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 8 weeks | 
| Blood Pressure | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 16 weeks | 
| Blood Pressure | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 20 weeks | 
| Blood Pressure | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 24 weeks | 
| Blood Pressure | 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.). | 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 | Pulse expressed as an absolute change from baseline. | 1 weeks | 
| Pulse | Pulse expressed as an absolute change from baseline. | 2 weeks | 
| Pulse | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. | 4 weeks | 
| Pulse | Pulse expressed as an absolute change from baseline. | 8 weeks | 
| Pulse | Pulse expressed as an absolute change from baseline. | 16 weeks | 
| Pulse | Pulse expressed as an absolute change from baseline. | 20 weeks | 
| Pulse | Pulse expressed as an absolute change from baseline. | 24 weeks | 
| Pulse | 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.). | 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 | Adherence will be assessed through documented use of meal replacements at each visit. | 4 weeks | 
| Adherence | Adherence will be assessed through documented use of meal replacements at each visit. | 8 weeks | 
| Adherence | Adherence will be assessed through documented use of meal replacements at each visit. | 16 weeks | 
| Adherence | Adherence will be assessed through documented use of meal replacements at each visit. | 20 weeks | 
| Adherence | Adherence will be assessed through documented use of meal replacements at each visit. | 24 weeks | 
| Adherence | 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.). | 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 | Change in body weight from baseline reported as absolute change. | 1 week | 
| Body Weight | Change in body weight from baseline reported as absolute change from baseline. | 2 weeks | 
| Body Weight | Change in body weight from baseline reported absolute change from baseline. | 4 weeks | 
| Body Weight | Change in body weight from baseline reported as absolute change. | 8 weeks | 
| Body Weight | Change in body weight from baseline reported as absolute change. | 16 weeks | 
| Body Weight | Change in body weight from baseline reported as absolute change. | 20 weeks | 
| Body Weight | 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.) | 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) | 
| Fat Mass | Fat mass expressed as an absolute change from baseline. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight Loss, Meal replacements, Weight maintenance