A Retrospective Chart Review of Three Medifast Weight Control Centers

Completed

• Conditions: Obesity

• Registration Number: NCT01662830
• Lead Sponsor: Medifast, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-08
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-08
• Last Update Submitted: 2012-08-08
• Study First Posted: 2012-08-10
• Last Update Posted: 2012-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in weight	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)	Weight loss (in pounds and percent weight loss) at weeks 4, 12, 24 and at final weight loss visit (average of 19.6 weeks).
Changes in body composition	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)	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).

Secondary Outcome Measures

Name	Time	Method
Compliance	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)	Compliance is measured by client attendance at weekly visits, consumption of meal replacements and dietary supplements, ketone testing, and completion of food journals
Retention rates	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)	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
Goal weight achievement	Final weight loss visit (average of 19.6 weeks)	The percent of clients that achieve thier goal weight by their 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	weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)	Improvements in diastolic and systolic blood pressure and pulse at weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks).