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.
Study Type
OBSERVATIONAL
Enrollment
372
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.
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.
Medifast, Inc.
Owings Mills, Maryland, United States
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.).
Time frame: 12 weeks
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).
Time frame: 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).
Time frame: 12 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 12 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 12 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 12 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 12 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 12 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 12 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 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.
Time frame: 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.).
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.).
Time frame: 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.
Time frame: 4 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 8 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 16 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 20 weeks
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 24 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 4 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 8 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 16 weeks
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 20 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 4 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 8 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 16 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 20 weeks
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 24 weeks
Waist Circumference
Waist circumference expressed as an absolute from baseline.
Time frame: 4 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 8 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 16 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 20 weeks
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 24 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 4 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 8 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 16 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 20 weeks
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 24 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 1 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 2 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 4 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 8 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 16 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 20 weeks
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 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.).
Time frame: 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.
Time frame: 1 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 2 weeks
Pulse
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 4 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 8 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 16 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 20 weeks
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 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.).
Time frame: 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.
Time frame: 4 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 8 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 16 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 20 weeks
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 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.).
Time frame: 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.
Time frame: 1 week
Body Weight
Change in body weight from baseline reported as absolute change from baseline.
Time frame: 2 weeks
Body Weight
Change in body weight from baseline reported absolute change from baseline.
Time frame: 4 weeks
Body Weight
Change in body weight from baseline reported as absolute change.
Time frame: 8 weeks
Body Weight
Change in body weight from baseline reported as absolute change.
Time frame: 16 weeks
Body Weight
Change in body weight from baseline reported as absolute change.
Time frame: 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.)
Time frame: 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.
Time frame: 24 weeks
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