A Retrospective Chart Review of Three Medifast Weight Control Centers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medifast, Inc.
ClinicalTrials.gov Identifier:
NCT01662830
First received: August 3, 2012
Last updated: August 8, 2012
Last verified: August 2012

August 3, 2012
August 8, 2012
April 2010
March 2012   (final data collection date for primary outcome measure)
  • Changes in weight [ Time Frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks) ] [ Designated as safety issue: No ]
    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).
Same as current
Complete list of historical versions of study NCT01662830 on ClinicalTrials.gov Archive Site
  • Compliance [ Time Frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Final weight loss visit (average of 19.6 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks) ] [ Designated as safety issue: No ]
  • Maintenance of weight loss [ Time Frame: Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program ] [ Designated as safety issue: No ]
  • Changes in cardiovascular risk factors [ Time Frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks) ] [ Designated as safety issue: No ]
    Improvements in diastolic and systolic blood pressure and pulse at weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks).
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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.

Obesity
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
446
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01662830
MED 016
No
Medifast, Inc.
Medifast, Inc.
Not Provided
Not Provided
Medifast, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP