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

Information source: Medifast, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: 5 & 2 & 2 Plan (Other); 4 & 2 & 1 Plan (Other)

Phase: N/A

Status: Completed

Sponsored by: Medifast, Inc.

Official(s) and/or principal investigator(s):
Linda M Aterburn, PhD, Principal Investigator, Affiliation: Medifast, Inc.

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.

Clinical Details

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 design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Body weight

Secondary outcome:

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Lean mass

Fat mass

Abdominal circumference

Waist circumference

Hip circumference

Blood pressure

Pulse

Blood pressure categorical

Resting metabolic rate

Adherence

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 5% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Proportion of subjects who lose at least 10% of baseline body weight

Lean mass

Lean mass

Lean mass

Lean mass

Lean mass

Fat mass

Fat mass

Fat mass

Fat mass

Fat mass

Abdominal circumference

Abdominal circumference

Abdominal circumference

Abdominal circumference

Abdominal circumference

Waist circumference

Waist circumference

Waist circumference

Waist circumference

Waist circumference

Hip circumference

Hip circumference

Hip circumference

Hip circumference

Hip circumference

Blood pressure

Blood pressure

Blood pressure

Blood pressure

Blood pressure

Blood pressure

Blood pressure

Blood pressure

Pulse

Pulse

Pulse

Pulse

Pulse

Pulse

Pulse

Pulse

Adherence

Adherence

Adherence

Adherence

Adherence

Adherence

Body weight

Body weight

Body weight

Body weight

Body weight

Body weight

Body weight

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Medifast, Inc., Owings Mills, Maryland 21117, United States
Additional Information

Starting date: January 2014
Last updated: May 27, 2014

Page last updated: August 23, 2015

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