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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
History of Changes
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medifast, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 446
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Medifast, Inc.
ClinicalTrials.gov Identifier: NCT01662830     History of Changes
Other Study ID Numbers: MED 016
Study First Received: August 3, 2012
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medifast, Inc.:
Obesity
Meal replacements

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013