Clinical trial NCT01662830: A Retrospective Chart Review of Three Medifast Weight Control Centers
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Meal replacements
Lead sponsor: Medifast, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in weight
timeFrame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
measure: Changes in body composition
timeFrame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Secondary outcomes:
measure: Compliance
timeFrame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
measure: Retention rates
timeFrame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
measure: Goal weight achievement
timeFrame: Final weight loss visit (average of 19.6 weeks)
measure: Changes in abdominal circumference (inches)
timeFrame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
measure: Maintenance of weight loss
timeFrame: Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program
measure: Changes in cardiovascular risk factors
timeFrame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.
citation: Haddock CK, Poston WS, Foreyt JP, DiBartolomeo JJ, Warner PO. Effectiveness of Medifast supplements combined with obesity pharmacotherapy: a clinical program evaluation. Eat Weight Disord. 2008 Jun;13(2):95-101. doi: 10.1007/BF03327609.