Clinical trial NCT01021917: SUCCESS Tracking Study
Official title: Weight Loss & Maintenance of Weight Loss Tracking Study (SUCCESS Tracking Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Keywords: Obesity
Weight Loss
Meal Replacements
Lead sponsor: Medifast, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-30
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling

Brief summary: 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.

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 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

Primary outcomes:
measure: To compare change in body weight among subjects in Medifast Direct, Take Shape For Life, and Other Dieters.
timeFrame: 4 months, 16 months, and at 5y follow-up
Secondary outcomes:
measure: To investigate attrition rates among subjects enrolled in Medifast Direct, Take Shape For Life, and Other Dieters.
timeFrame: 4 months, 16 months, and at 5 yr follow-up
measure: To evaluate potential predictors of successful weight loss & maintenance of weight loss.
timeFrame: 4 months, 16 months, and at 5 yr follow-up
measure: To examine the effects of Medifast Direct and Take Shape For Life programs on intake, health & quality of life outcomes, and eating behaviors.
timeFrame: 4 months, 16 months, and at 5y follow-up
measure: To explore potential differences between subgroups in change in body weight and attrition.
timeFrame: 4 months, 16 months, and at 5y follow-up
Other outcomes:
Locations:
city: Owings Mills
country: United States
facility: Medifast Inc.
state: Maryland
Study officials:
affiliation: Medifast, Inc.
name: Lisa M Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medifast, Inc.
name: Christopher D Coleman, MS
role: STUDY_DIRECTOR
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