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Completed

NCT Number: NCT01662830

A Retrospective Chart Review of Three Medifast Weight Control Centers

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes in weight

    Time frame: 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).

  2. Changes in body composition

    Time frame: 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 outcomes

  1. Compliance

    Time frame: 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

  2. Retention rates

    Time frame: 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

  3. Goal weight achievement

    Time frame: 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)

  4. Changes in abdominal circumference (inches)

    Time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)

  5. Maintenance of weight loss

    Time frame: Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program

  6. Changes in cardiovascular risk factors

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Medifast, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2012
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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