A Retrospective Chart Review of Three Medifast Weight Control Centers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MWCC clients<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Meal replacements