A Retrospective Chart Review of Three Medifast Weight Control Centers

NCT01662830 | Completed

• 1 other identifier: MED 016
• Study Type: observational
• Target: 446
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Obesity; Meal replacements

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Compliance

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

• Retention rates

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

• Goal weight achievement

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medifast, Inc.: lead

Related Publications (2)

• 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.

  PMID: 12704397 BACKGROUND

• 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.

  PMID: 18612258 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 10, 2012
• Study Start: April 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 10, 2012

Record last verified: 2012-08