SUCCESS Tracking Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Weight Loss & Maintenance of Weight Loss Tracking Study (SUCCESS Tracking Study)

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other Dieters (OD)<br>Those participating in weight loss programs other than Medifast Direct or Take Shape For Life. | |
| Take Shape For Life (TSFL)<br>Those using Medifast meal replacement products for weight loss while working closely with a Take Shape For Life certified Health Coach. | |
| Medifast Direct (MD)<br>Those using Medifast meal replacement products specifically for weight loss that were purchased directly from the company and individually monitored by the customer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare change in body weight among subjects in Medifast Direct, Take Shape For Life, and Other Dieters. |  | 4 months, 16 months, and at 5y follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate attrition rates among subjects enrolled in Medifast Direct, Take Shape For Life, and Other Dieters. |  | 4 months, 16 months, and at 5 yr follow-up | 
| To evaluate potential predictors of successful weight loss & maintenance of weight loss. |  | 4 months, 16 months, and at 5 yr follow-up | 
| To examine the effects of Medifast Direct and Take Shape For Life programs on intake, health & quality of life outcomes, and eating behaviors. |  | 4 months, 16 months, and at 5y follow-up | 
| To explore potential differences between subgroups in change in body weight and attrition. |  | 4 months, 16 months, and at 5y follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight Loss, Meal Replacements