Obesity
Conditions
Keywords
Obesity, Weight Loss, Meal replacements, Weight maintenance
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.
Interventions
OTHER5 & 2 & 2 Plan
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.
OTHER4 & 2 & 1 Plan
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.
Sponsors
Medifast, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 12 weeks | 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). |
| Lean Mass | 12 weeks | Lean mass expressed as an absolute change from baseline. |
| Fat Mass | 12 weeks | Fat mass expressed as an absolute change from baseline. |
| Abdominal Circumference | 12 weeks | Abdominal circumference expressed as an absolute change from baseline. |
| Waist Circumference | 12 weeks | Waist circumference expressed as an absolute change from baseline. |
| Hip Circumference | 12 weeks | Hip circumference expressed as an absolute change from baseline. |
| 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). |
| Pulse | 12 weeks | Pulse expressed as an absolute change from baseline. |
| 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 | 12 weeks | 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 |
| Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 1 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). |
| Body Weight | 1 week | Change in body weight from baseline reported as absolute change. |
| Blood Pressure | 12 weeks | Blood pressure (systolic and diastolic) expressed as an absolute change from baseline. |
Countries
United States
Participant flow
Recruitment details
This is a retrospective chart review of Medifast Weight Control Center (MWCC) clients from 21 centers that used either the Medifast 5 & 2 & 2 Plan or 4 & 2 & 1 Plan for weight loss between 1/2012 and 3/2014 - it is retropsective and observational in nature, so there was no recruitment involved. The plans were evaluated separately and not compared.
Participants by arm
| Arm | Count |
|---|---|
| 5 & 2 & 2 Plan MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss.
5 & 2 & 2 Plan: 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. | 62 |
| 4 & 2 & 1 Plan MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss.
4 & 2 & 1 Plan: 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. | 310 |
| Total | 372 |
Baseline characteristics
| Characteristic | 5 & 2 & 2 Plan | 4 & 2 & 1 Plan | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 88 Participants | 95 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 222 Participants | 277 Participants |
| Age, Continuous | 46.8 years STANDARD_DEVIATION 13.7 | 53.5 years STANDARD_DEVIATION 14.7 | 52.4 years STANDARD_DEVIATION 14.8 |
| BMI | 48.7 kg/m2 STANDARD_DEVIATION 9.9 | 37.7 kg/m2 STANDARD_DEVIATION 6.8 | 39.5 kg/m2 STANDARD_DEVIATION 8.5 |
| Body Fat Mass | 152.46 Pounds STANDARD_DEVIATION 41.36 | 103.40 Pounds STANDARD_DEVIATION 30.58 | 110.04 Pounds STANDARD_DEVIATION 36.41 |
| Lean Body Mass | 168.52 Pounds STANDARD_DEVIATION 31.46 | 135.96 Pounds STANDARD_DEVIATION 31.24 | 140.33 Pounds STANDARD_DEVIATION 33.09 |
| Region of Enrollment United States | 62 participants | 310 participants | 372 participants |
| Sex: Female, Male Female | 27 Participants | 177 Participants | 204 Participants |
| Sex: Female, Male Male | 35 Participants | 133 Participants | 168 Participants |
| Weight | 327.11 Pounds STANDARD_DEVIATION 64.33 | 240.00 Pounds STANDARD_DEVIATION 47.83 | 254.02 Pounds STANDARD_DEVIATION 60.25 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 310 |
| other Total, other adverse events | 46 / 62 | 219 / 310 |
| serious Total, serious adverse events | 2 / 62 | 9 / 310 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Body Weight | -28.35 Pounds | Standard Deviation 15.6 |
| 4 & 2 & 1 Plan | Body Weight | -23.95 Pounds | Standard Deviation 12.28 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Abdominal Circumference | -6.25 Inches | Standard Deviation 1.89 |
| 4 & 2 & 1 Plan | Abdominal Circumference | -5.78 Inches | Standard Deviation 3.06 |
Secondary
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Abdominal Circumference | -4.42 Inches | Standard Deviation 3.04 |
| 4 & 2 & 1 Plan | Abdominal Circumference | -3.28 Inches | Standard Deviation 1.99 |
Secondary
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Abdominal Circumference | -5.71 Inches | Standard Deviation 1.19 |
| 4 & 2 & 1 Plan | Abdominal Circumference | -4.46 Inches | Standard Deviation 2.73 |
Secondary
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Abdominal Circumference | -2.81 Inches | Standard Deviation 2.08 |
| 4 & 2 & 1 Plan | Abdominal Circumference | -1.86 Inches | Standard Deviation 1.71 |
Secondary
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 12 weeks
Population: Not all subjects remaining at 12 weeks had measurement performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Abdominal Circumference | -3.70 Inches | Standard Deviation 1.3 |
| 4 & 2 & 1 Plan | Abdominal Circumference | -4.47 Inches | Standard Deviation 2.59 |
Secondary
Abdominal Circumference
Abdominal circumference expressed as an absolute change from baseline.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Abdominal Circumference | -4.83 Inches | Standard Deviation 5.16 |
| 4 & 2 & 1 Plan | Abdominal Circumference | -5.98 Inches | Standard Deviation 2.74 |
Secondary
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Adherence | 90.67 Percent compliance meal replacements | Standard Deviation 14.86 |
| 4 & 2 & 1 Plan | Adherence | 91.22 Percent compliance meal replacements | Standard Deviation 23.47 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Adherence | 82.41 Percent compliance meal replacements | Standard Deviation 27.49 |
| 4 & 2 & 1 Plan | Adherence | 85.26 Percent compliance meal replacements | Standard Deviation 29.43 |
Secondary
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Adherence | 89.00 Percent compliance meal replacements | Standard Deviation 18.04 |
| 4 & 2 & 1 Plan | Adherence | 89.25 Percent compliance meal replacements | Standard Deviation 26.79 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Adherence | Meal replacement compliance | 83.85 Percent Compliant | Standard Deviation 16.67 |
| 5 & 2 & 2 Plan | Adherence | Attendance compliance | 83.65 Percent Compliant | Standard Deviation 19.09 |
| 4 & 2 & 1 Plan | Adherence | Meal replacement compliance | 88.79 Percent Compliant | Standard Deviation 18.64 |
| 4 & 2 & 1 Plan | Adherence | Attendance compliance | 85.71 Percent Compliant | Standard Deviation 17.94 |
Secondary
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Adherence | 79.52 Percent compliance meal replacements | Standard Deviation 26.55 |
| 4 & 2 & 1 Plan | Adherence | 94.29 Percent compliance meal replacements | Standard Deviation 17.19 |
Secondary
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Adherence | 94.53 Percent compliance meal replacements | Standard Deviation 13.09 |
| 4 & 2 & 1 Plan | Adherence | 96.29 Percent compliance meal replacements | Standard Deviation 14.45 |
Secondary
Adherence
Adherence will be assessed through documented use of meal replacements at each visit.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Adherence | 88.3 Percent compliance meal replacements | Standard Deviation 20.99 |
| 4 & 2 & 1 Plan | Adherence | 95.17 Percent compliance meal replacements | Standard Deviation 14.97 |
Secondary
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 20 weeks
Population: Not all subjects were remaining at 20 weeks and not all had measurement performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -21.55 mmHg | Standard Deviation 20.62 |
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -8.55 mmHg | Standard Deviation 11.12 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -9.34 mmHg | Standard Deviation 17.49 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -6.26 mmHg | Standard Deviation 13.05 |
Secondary
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 1 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -4.63 mmHg | Standard Deviation 17.17 |
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -2.63 mmHg | Standard Deviation 10.49 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -5.80 mmHg | Standard Deviation 14.05 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -3.59 mmHg | Standard Deviation 9.98 |
Secondary
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 2 weeks
Population: Not all subjects were remaining at 2 weeks and not all had measurement performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -2.91 mmHg | Standard Deviation 9.89 |
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -6.41 mmHg | Standard Deviation 15.63 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -5.37 mmHg | Standard Deviation 10.84 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -8.53 mmHg | Standard Deviation 13.97 |
Secondary
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 12 weeks
Population: Not all subjects were remaining at 12 weeks and not all had measurement performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -17.69 mmHg | Standard Deviation 17.61 |
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -8.38 mmHg | Standard Deviation 8.01 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -11.27 mmHg | Standard Deviation 16.65 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -6.60 mmHg | Standard Deviation 12.62 |
Secondary
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 4 weeks
Population: Not all subjects were remaining at 4 weeks and not all had measurement performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -7.81 mmHg | Standard Deviation 19.76 |
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -7.31 mmHg | Standard Deviation 9 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -9.87 mmHg | Standard Deviation 16.93 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -5.90 mmHg | Standard Deviation 12.13 |
Secondary
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 8 weeks
Population: Not all subjects were remaining at 8 weeks and not all had measurement performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -14.21 mmHg | Standard Deviation 26.06 |
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -9.25 mmHg | Standard Deviation 11.3 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -7.51 mmHg | Standard Deviation 14.68 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -6.11 mmHg | Standard Deviation 11.09 |
Secondary
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)
Population: Not all subjects had measurement performed at their final visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -16.96 mmHg | Standard Deviation 21.79 |
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -7.08 mmHg | Standard Deviation 10.68 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -9.52 mmHg | Standard Deviation 15.62 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -5.64 mmHg | Standard Deviation 11.58 |
Secondary
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 24 weeks
Population: Not all subjects were remaining at 24 weeks and not all had measurement performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -14.33 mmHg | Standard Deviation 16.19 |
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -5.44 mmHg | Standard Deviation 8.41 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -7.79 mmHg | Standard Deviation 19.4 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -3.92 mmHg | Standard Deviation 14.18 |
Secondary
Blood Pressure
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 16 weeks
Population: Not all subjects were remaining at 16 weeks and not all had measurement performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure | Systolic | -19.27 mmHg | Standard Deviation 25.09 |
| 5 & 2 & 2 Plan | Blood Pressure | Diastolic | -8.55 mmHg | Standard Deviation 11.6 |
| 4 & 2 & 1 Plan | Blood Pressure | Systolic | -10.59 mmHg | Standard Deviation 17.03 |
| 4 & 2 & 1 Plan | Blood Pressure | Diastolic | -6.84 mmHg | Standard Deviation 9.94 |
Secondary
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
Population: Not all subjects were remaining at 12 weeks and not all had measurement performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Blood Pressure Categorical | 53.8 Percent of participants |
| 4 & 2 & 1 Plan | Blood Pressure Categorical | 49.1 Percent of participants |
Secondary
Body Weight
Change in body weight from baseline reported as absolute change.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Body Weight | -7.64 Pounds | Standard Deviation 4.86 |
| 4 & 2 & 1 Plan | Body Weight | -5.95 Pounds | Standard Deviation 3.33 |
Secondary
Body Weight
Change in body weight from baseline reported as absolute change.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Body Weight | -40.51 Pounds | Standard Deviation 19.08 |
| 4 & 2 & 1 Plan | Body Weight | -32.42 Pounds | Standard Deviation 16.22 |
Secondary
Body Weight
Change in body weight from baseline reported as absolute change from baseline.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Body Weight | -9.71 Pounds | Standard Deviation 4.95 |
| 4 & 2 & 1 Plan | Body Weight | -8.24 Pounds | Standard Deviation 4.27 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Body Weight | -29.25 Pounds | Standard Deviation 27.65 |
| 4 & 2 & 1 Plan | Body Weight | -23.34 Pounds | Standard Deviation 18.65 |
Secondary
Body Weight
Change in body weight from baseline reported as absolute change.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Body Weight | -22.81 Pound | Standard Deviation 11.21 |
| 4 & 2 & 1 Plan | Body Weight | -18.32 Pound | Standard Deviation 9.21 |
Secondary
Body Weight
Change in body weight from baseline reported as absolute change.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Body Weight | -36.89 Pounds | Standard Deviation 16.45 |
| 4 & 2 & 1 Plan | Body Weight | -28.84 Pounds | Standard Deviation 14.48 |
Secondary
Body Weight
Change in body weight from baseline reported absolute change from baseline.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Body Weight | -14.26 Pounds | Standard Deviation 6.88 |
| 4 & 2 & 1 Plan | Body Weight | -12.25 Pounds | Standard Deviation 6.01 |
Secondary
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Fat Mass | -34.03 Pounds | Standard Deviation 11.64 |
| 4 & 2 & 1 Plan | Fat Mass | -29.03 Pounds | Standard Deviation 17 |
Secondary
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Fat Mass | -11.46 Pounds | Standard Deviation 6.92 |
| 4 & 2 & 1 Plan | Fat Mass | -9.09 Pounds | Standard Deviation 7.71 |
Secondary
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 24 weeks
Population: Not all subjects remaining at 24 weeks had body composition testing performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Fat Mass | -56.88 Pounds | Standard Deviation 18.52 |
| 4 & 2 & 1 Plan | Fat Mass | -32.00 Pounds | Standard Deviation 15.76 |
Secondary
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Fat Mass | -26.38 Pounds | Standard Deviation 9.11 |
| 4 & 2 & 1 Plan | Fat Mass | -26.34 Pounds | Standard Deviation 12.16 |
Secondary
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Fat Mass | -17.35 Pounds | Standard Deviation 5.8 |
| 4 & 2 & 1 Plan | Fat Mass | -16.27 Pounds | Standard Deviation 8.16 |
Secondary
Fat Mass
Fat mass expressed as an absolute change from baseline.
Time frame: 12 weeks
Population: Not all subjects remaining at 12 weeks had body composition testing performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Fat Mass | -21.09 Pounds | Standard Deviation 8.09 |
| 4 & 2 & 1 Plan | Fat Mass | -21.25 Pounds | Standard Deviation 10.9 |
Secondary
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Hip Circumference | -5.17 Inches | Standard Deviation 3.33 |
| 4 & 2 & 1 Plan | Hip Circumference | -4.92 Inches | Standard Deviation 2.68 |
Secondary
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Hip Circumference | -4.42 Inches | Standard Deviation 3.02 |
| 4 & 2 & 1 Plan | Hip Circumference | -3.97 Inches | Standard Deviation 2.15 |
Secondary
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Hip Circumference | -3.34 Inches | Standard Deviation 1.99 |
| 4 & 2 & 1 Plan | Hip Circumference | -2.68 Inches | Standard Deviation 1.64 |
Secondary
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 12 weeks
Population: Not all subjects remaining at 12 weeks had measurement performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Hip Circumference | -4.18 Inches | Standard Deviation 2.96 |
| 4 & 2 & 1 Plan | Hip Circumference | -3.41 Inches | Standard Deviation 2.22 |
Secondary
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Hip Circumference | -5.38 Inches | Standard Deviation 1.9 |
| 4 & 2 & 1 Plan | Hip Circumference | -5.38 Inches | Standard Deviation 3.96 |
Secondary
Hip Circumference
Hip circumference expressed as an absolute change from baseline.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Hip Circumference | -2.40 Inches | Standard Deviation 1.88 |
| 4 & 2 & 1 Plan | Hip Circumference | -1.56 Inches | Standard Deviation 1.36 |
Secondary
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Lean Mass | -5.19 Pounds | Standard Deviation 5.42 |
| 4 & 2 & 1 Plan | Lean Mass | -4.50 Pounds | Standard Deviation 4.66 |
Secondary
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 12 weeks
Population: Not all subjects remaining at 12 weeks had body composition testing performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Lean Mass | -5.47 Pounds | Standard Deviation 6.41 |
| 4 & 2 & 1 Plan | Lean Mass | -5.31 Pounds | Standard Deviation 4.89 |
Secondary
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Lean Mass | -8.36 Pounds | Standard Deviation 5.67 |
| 4 & 2 & 1 Plan | Lean Mass | -4.49 Pounds | Standard Deviation 5.36 |
Secondary
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Lean Mass | -11.15 Pounds | Standard Deviation 4.62 |
| 4 & 2 & 1 Plan | Lean Mass | -4.29 Pounds | Standard Deviation 6.45 |
Secondary
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Lean Mass | -13.83 Pounds | Standard Deviation 5.33 |
| 4 & 2 & 1 Plan | Lean Mass | -5.08 Pounds | Standard Deviation 6.96 |
Secondary
Lean Mass
Lean mass expressed as an absolute change from baseline.
Time frame: 24 weeks
Population: Not all subjects were remaining at 24 weeks and not all had measurement performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Lean Mass | -14.35 Pounds | Standard Deviation 9.14 |
| 4 & 2 & 1 Plan | Lean Mass | -6.79 Pounds | Standard Deviation 6.45 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight | 75.7 percentage of subjects |
| 4 & 2 & 1 Plan | Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight | 85.4 percentage of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 0.0 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 0.0 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 0.0 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 0.0 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 16.7 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 23.0 Percent of subjects |
Secondary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 29.0 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 39.9 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 58.8 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 75.3 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 56.5 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 69.6 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 50.0 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 64.9 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 0.0 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 1.0 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 40.5 percentage of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight | 50.8 percentage of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 33.3 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 50.2 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 88.2 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 96.3 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 95.7 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 94.6 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 95.8 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 92.7 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 72.9 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 76.2 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 1.6 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 3.2 Percent of subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 8.9 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 16.1 Percent of subjects |
Secondary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 & 2 & 2 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 62.9 Percent of subjects |
| 4 & 2 & 1 Plan | Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight | 69.6 Percent of subjects |
Secondary
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | -1.17 Beats per minute | Standard Deviation 17.84 |
| 4 & 2 & 1 Plan | Pulse | -2.65 Beats per minute | Standard Deviation 10.71 |
Secondary
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 1 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | -0.46 Beats per minute | Standard Deviation 12.86 |
| 4 & 2 & 1 Plan | Pulse | 1.07 Beats per minute | Standard Deviation 9.42 |
Secondary
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | -3.27 mmHg | Standard Deviation 10.27 |
| 4 & 2 & 1 Plan | Pulse | -1.21 mmHg | Standard Deviation 9.94 |
Secondary
Pulse
Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | -1.62 Beats per minute | Standard Deviation 12.52 |
| 4 & 2 & 1 Plan | Pulse | -2.88 Beats per minute | Standard Deviation 10.11 |
Secondary
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | -3.27 Beats per minute | Standard Deviation 11.29 |
| 4 & 2 & 1 Plan | Pulse | -3.73 Beats per minute | Standard Deviation 11.89 |
Secondary
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | 0.27 Beats per minute | Standard Deviation 13.27 |
| 4 & 2 & 1 Plan | Pulse | -2.31 Beats per minute | Standard Deviation 11.78 |
Secondary
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | 0.00 Beats per minute | Standard Deviation 4.66 |
| 4 & 2 & 1 Plan | Pulse | -3.67 Beats per minute | Standard Deviation 9.34 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | -2.29 Beats per minute | Standard Deviation 10.75 |
| 4 & 2 & 1 Plan | Pulse | -2.29 Beats per minute | Standard Deviation 11.63 |
Secondary
Pulse
Pulse expressed as an absolute change from baseline.
Time frame: 12 weeks
Population: Not all subjects were remaining at 12 weeks and not all had measurement performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Pulse | -3.62 Beats per minute | Standard Deviation 10.04 |
| 4 & 2 & 1 Plan | Pulse | -2.95 Beats per minute | Standard Deviation 10.48 |
Secondary
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)
Population: Number of participants with paired data at baseline and final weight loss visit was too small for meaningful analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Resting Metabolic Rate | 10 calories | Standard Deviation 0 |
| 4 & 2 & 1 Plan | Resting Metabolic Rate | -216.67 calories | Standard Deviation 279.48 |
Secondary
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Waist Circumference | -4.38 Inches | Standard Deviation 2.06 |
| 4 & 2 & 1 Plan | Waist Circumference | -4.75 Inches | Standard Deviation 2.22 |
Secondary
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Waist Circumference | -6.93 Inches | Standard Deviation 2.49 |
| 4 & 2 & 1 Plan | Waist Circumference | -5.32 Inches | Standard Deviation 2.7 |
Secondary
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 12 weeks
Population: Not all subjects remaining at 12 weeks had measurement performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Waist Circumference | -3.55 Inches | Standard Deviation 1.83 |
| 4 & 2 & 1 Plan | Waist Circumference | -3.87 Inches | Standard Deviation 2.34 |
Secondary
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Waist Circumference | -3.60 Inches | Standard Deviation 2.42 |
| 4 & 2 & 1 Plan | Waist Circumference | -3.24 Inches | Standard Deviation 1.72 |
Secondary
Waist Circumference
Waist circumference expressed as an absolute change from baseline.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Waist Circumference | -3.92 Inches | Standard Deviation 3.89 |
| 4 & 2 & 1 Plan | Waist Circumference | -5.35 Inches | Standard Deviation 2.88 |
Secondary
Waist Circumference
Waist circumference expressed as an absolute from baseline.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 & 2 & 2 Plan | Waist Circumference | -2.21 Inches | Standard Deviation 1.49 |
| 4 & 2 & 1 Plan | Waist Circumference | -1.97 Inches | Standard Deviation 1.37 |