A Retrospective Chart Review of Three Medifast Weight Control Centers

Use of the Medifast Meal Replacement Program for Weight Loss in Obese Patients: A Restrospective Chart Review of Three Medifast Weight Control Centers (MWCC)

The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.

Study Overview

• Status: Completed
• Conditions: Obesity

Detailed Description

Portion-controlled meal replacements by themselves have been shown to be an effective weight control strategy in overweight and obese individuals. The addition of medical supervision has been shown to result in greater weight loss than meal replacements alone. MWCC provides this added support through individual weekly counseling sessions. Thus, the investigators plan to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.

• Study Type: Observational
• Enrollment (Actual): 446

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study was a systematic retrospective chart review of patients participating in the Jump Start (5 & 1) Plan at three different MWCC locations in Texas during the years 2007-2010.

Description

Inclusion Criteria:

• Adult males and females aged 18-70
• Followed the Jump Start (5 & 1) Plan
• BMI ≥ 25
• Purchased a weight management program at the MWCC location in the last 3 years
• Signed patient health information consent form

Exclusion Criteria:

• On a plan other than the 5&1 (Jump Start)
• Completed initial consultation but did not participate further
• Program stopped due to client not getting baseline labs
• Program stopped due for medical reasons unrelated to the 5 & 1 (Jump Start) plan
• Currently an active participant at the MWCC
• No signed patient health information consent form or written request to revoke consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MWCC clients; This study will be a systematic retrospective chart review of clients participating in the Jump Start (5 & 1) Plan at three different MWCC locations in Texas during the years 2007 - 2010.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight	Weight loss (in pounds and percent weight loss) at weeks 4, 12, 24 and at final weight loss visit (average of 19.6 weeks).	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Changes in body composition	changes in lean muscle mass, body fat mass, and body fat percent at weeks 4, 12, 24, and final weight loss visit(average of 19.6 weeks).	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Compliance is measured by client attendance at weekly visits, consumption of meal replacements and dietary supplements, ketone testing, and completion of food journals	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Retention rates	Retention of clients at specified time points (weeks 4, 12, 24 and final weight loss visit) and during the transition and weight maintenance phases of the MWCC weight management program	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Goal weight achievement	The percent of clients that achieve thier goal weight by their final weight loss visit(average of 19.6 weeks)	Final weight loss visit (average of 19.6 weeks)
Changes in abdominal circumference (inches)		weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Maintenance of weight loss		Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program
Changes in cardiovascular risk factors	Improvements in diastolic and systolic blood pressure and pulse at weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks).	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)

Collaborators and Investigators

• Sponsor: Medifast, Inc.

Publications and helpful links

General Publications

• Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.
• Haddock CK, Poston WS, Foreyt JP, DiBartolomeo JJ, Warner PO. Effectiveness of Medifast supplements combined with obesity pharmacotherapy: a clinical program evaluation. Eat Weight Disord. 2008 Jun;13(2):95-101. doi: 10.1007/BF03327609.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Estimate): August 10, 2012
• Last Update Submitted That Met QC Criteria: August 8, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Obesity; Meal replacements
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: MED 016