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

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

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: 5 & 2 & 2 Plan; Other: 4 & 2 & 1 Plan

• Study Type: Observational
• Enrollment (Actual): 372

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Owings Mills, Maryland, United States, 21117
      • Medifast, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study is a systematic retrospective chart review of existing MWCC charts located in Maryland, Texas, Florida or Pennsylvania for MWCC members who used either the Medifast 5 & 2 & 2 Plan or the Medifast 4 & 2 & 1 Plan for weight loss.

Charts will be reviewed for members that started either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan on or after January 1, 2012. This start date was chosen because it represents the date when Medifast began using the current versions of the 5 & 2 & 2 Plan and the 4 & 2 & 1 Plan. Only charts of those members who are no longer in the active weight loss phase of their program at the MWCC will be considered for the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
5 & 2 & 2 Plan; MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss.	Other: 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.
4 & 2 & 1 Plan; MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss.	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medifast, Inc.
• Investigators: Principal Investigator: Linda M Aterburn, PhD, Medifast, Inc.

Publications and helpful links

General Publications

• Coleman CD, Kiel JR, Mitola AH, Langford JS, Davis KN, Arterburn LM. Effectiveness of a Medifast meal replacement program on weight, body composition and cardiometabolic risk factors in overweight and obese adults: a multicenter systematic retrospective chart review study. Nutr J. 2015 Aug 6;14:77. doi: 10.1186/s12937-015-0062-8.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Weight Loss; Weight maintenance; Meal replacements
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: MED 017