SUCCESS Tracking Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medifast, Inc.
ClinicalTrials.gov Identifier:
NCT01021917
First received: November 25, 2009
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

The overall purpose of this research is to evaluate the long-term outcomes associated with participation in Medifast Direct and Take Shape For Life weight-loss programs in comparison with non-Medifast weight-loss programs. Another important goal of this research is to determine whether the differences between Medifast Direct and Take Shape For Life programs affect weight-loss and maintenance of weight-loss in customers.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Weight Loss & Maintenance of Weight Loss Tracking Study (SUCCESS Tracking Study)

Resource links provided by NLM:


Further study details as provided by Medifast, Inc.:

Primary Outcome Measures:
  • To compare change in body weight among subjects in Medifast Direct, Take Shape For Life, and Other Dieters. [ Time Frame: 4 months, 16 months, and at 5y follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate attrition rates among subjects enrolled in Medifast Direct, Take Shape For Life, and Other Dieters. [ Time Frame: 4 months, 16 months, and at 5 yr follow-up ] [ Designated as safety issue: No ]
  • To evaluate potential predictors of successful weight loss & maintenance of weight loss. [ Time Frame: 4 months, 16 months, and at 5 yr follow-up ] [ Designated as safety issue: No ]
  • To examine the effects of Medifast Direct and Take Shape For Life programs on intake, health & quality of life outcomes, and eating behaviors. [ Time Frame: 4 months, 16 months, and at 5y follow-up ] [ Designated as safety issue: No ]
  • To explore potential differences between subgroups in change in body weight and attrition. [ Time Frame: 4 months, 16 months, and at 5y follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 332
Study Start Date: March 2008
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Other Dieters (OD)
Those participating in weight loss programs other than Medifast Direct or Take Shape For Life.
Take Shape For Life (TSFL)
Those using Medifast meal replacement products for weight loss while working closely with a Take Shape For Life certified Health Coach.
Medifast Direct (MD)
Those using Medifast meal replacement products specifically for weight loss that were purchased directly from the company and individually monitored by the customer.

Detailed Description:

Researchers desire to capture the behaviors and outcomes of those individuals who would enroll in these programs without the additional encouragement to be a participant in a research study. The study will employ an observational prospective design intended to introduce as little interference as possible with subjects' behaviors. This is in order to capture the pure effects of the weight-loss programs themselves, and to reduce the potentially confounding effects of merely participating in a research study. Subjects who have already committed to a weight-loss program (Medifast Direct, Take Shape For Life , or other) will be recruited to join this study, and will be asked to complete several questionnaires over a period of up to 6 ⅓ years after enrollment. Questionnaires will measure information regarding anthropometrics, sociodemographics, and health & quality of life outcomes. The overall goal of this research is to be able to describe and compare the long-term dieting behaviors and outcomes among participants in Medifast Direct and Take Shape For Life programs in comparison with other dieters.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community-dwelling

Criteria

Inclusion Criteria:

  • Adult males and females between the ages of 18 - 69 years
  • BMI ( > 25.0 kg/m2)
  • Beginning a weight loss diet plan (MD, TSFL, or one of a number of commercially available plans)NOTE: subjects must have already committed to a weight-loss plan in order to be eligible for this study. The recruitment process is specifically designed so as NOT to appear to encourage subjects to begin a weight-loss plan. Rather, the purpose of this research is to track information about persons who have already committed to a weight-loss program.
  • Willing and able to give informed consent
  • Willing and able to comply with study protocol

Exclusion Criteria:

  • Unable to give informed consent
  • Previous hospitalization for psychiatric disorder or eating disorder
  • Current, uncontrolled medical conditions
  • Taking unstable doses of weight-loss or appetite-affecting medications (e.g., SSRIs, steroids, Ritalin)
  • Taking prescription weight-loss drugs (Phentermine, Sibutramine, Orlistat, etc…)
  • Have undergone, or plan to undergo, weight loss surgery (e.g. gastric bypass, lap band, duodenal switch) in the next 6 1/3 years
  • Plan to undergo weight-altering cosmetic surgery procedures (e.g. breast reduction/augmentation, tummy tuck, liposuction, or other skin removal procedures) in the next 6 1/3 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021917

Locations
United States, Maryland
Medifast Inc.
Owings Mills, Maryland, United States, 21117
Sponsors and Collaborators
Medifast, Inc.
Investigators
Principal Investigator: Lisa M Davis, PhD Medifast, Inc.
Study Director: Christopher D Coleman, MS Medifast, Inc.
  More Information

Publications:

Responsible Party: Medifast, Inc.
ClinicalTrials.gov Identifier: NCT01021917     History of Changes
Other Study ID Numbers: MED013, 20071961
Study First Received: November 25, 2009
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medifast, Inc.:
Obesity
Weight Loss
Meal Replacements

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

ClinicalTrials.gov processed this record on August 28, 2014