Clinical trial NCT02150837: Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Weight Loss
Meal replacements
Weight maintenance
Lead sponsor: Medifast, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 12 weeks
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 12 weeks
measure: Lean Mass
timeFrame: 12 weeks
measure: Fat Mass
timeFrame: 12 weeks
measure: Abdominal Circumference
timeFrame: 12 weeks
measure: Waist Circumference
timeFrame: 12 weeks
measure: Hip Circumference
timeFrame: 12 weeks
measure: Blood Pressure
timeFrame: 12 weeks
measure: Pulse
timeFrame: 12 weeks
measure: Blood Pressure Categorical
timeFrame: 12 weeks
measure: Resting Metabolic Rate
timeFrame: 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)
measure: Adherence
timeFrame: 12 weeks
measure: Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 1 weeks
measure: Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 2 weeks
measure: Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 4 weeks
measure: Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 8 weeks
measure: Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 16 weeks
measure: Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 20 weeks
measure: Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 24 weeks
measure: Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
timeFrame: 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)
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 1 weeks
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 2 weeks
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 4 weeks
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 8 weeks
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 16 weeks
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 20 weeks
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 24 weeks
measure: Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
timeFrame: 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)
measure: Lean Mass
timeFrame: 4 weeks
measure: Lean Mass
timeFrame: 8 weeks
measure: Lean Mass
timeFrame: 16 weeks
measure: Lean Mass
timeFrame: 20 weeks
measure: Lean Mass
timeFrame: 24 weeks
measure: Fat Mass
timeFrame: 4 weeks
measure: Fat Mass
timeFrame: 8 weeks
measure: Fat Mass
timeFrame: 16 weeks
measure: Fat Mass
timeFrame: 20 weeks
measure: Abdominal Circumference
timeFrame: 4 weeks
measure: Abdominal Circumference
timeFrame: 8 weeks
measure: Abdominal Circumference
timeFrame: 16 weeks
measure: Abdominal Circumference
timeFrame: 20 weeks
measure: Abdominal Circumference
timeFrame: 24 weeks
measure: Waist Circumference
timeFrame: 4 weeks
measure: Waist Circumference
timeFrame: 8 weeks
measure: Waist Circumference
timeFrame: 16 weeks
measure: Waist Circumference
timeFrame: 20 weeks
measure: Waist Circumference
timeFrame: 24 weeks
measure: Hip Circumference
timeFrame: 4 weeks
measure: Hip Circumference
timeFrame: 8 weeks
measure: Hip Circumference
timeFrame: 16 weeks
measure: Hip Circumference
timeFrame: 20 weeks
measure: Hip Circumference
timeFrame: 24 weeks
measure: Blood Pressure
timeFrame: 1 weeks
measure: Blood Pressure
timeFrame: 2 weeks
measure: Blood Pressure
timeFrame: 4 weeks
measure: Blood Pressure
timeFrame: 8 weeks
measure: Blood Pressure
timeFrame: 16 weeks
measure: Blood Pressure
timeFrame: 20 weeks
measure: Blood Pressure
timeFrame: 24 weeks
measure: Blood Pressure
timeFrame: 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)
measure: Pulse
timeFrame: 1 weeks
measure: Pulse
timeFrame: 2 weeks
measure: Pulse
timeFrame: 4 weeks
measure: Pulse
timeFrame: 8 weeks
measure: Pulse
timeFrame: 16 weeks
measure: Pulse
timeFrame: 20 weeks
measure: Pulse
timeFrame: 24 weeks
measure: Pulse
timeFrame: 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)
measure: Adherence
timeFrame: 4 weeks
measure: Adherence
timeFrame: 8 weeks
measure: Adherence
timeFrame: 16 weeks
measure: Adherence
timeFrame: 20 weeks
measure: Adherence
timeFrame: 24 weeks
measure: Adherence
timeFrame: 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)
measure: Body Weight
timeFrame: 1 week
measure: Body Weight
timeFrame: 2 weeks
measure: Body Weight
timeFrame: 4 weeks
measure: Body Weight
timeFrame: 8 weeks
measure: Body Weight
timeFrame: 16 weeks
measure: Body Weight
timeFrame: 20 weeks
measure: Body Weight
timeFrame: 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)
measure: Fat Mass
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Owings Mills
country: United States
facility: Medifast, Inc.
state: Maryland
Study officials:
affiliation: Medifast, Inc.
name: Linda M Aterburn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.