Overview

This trial is active, not recruiting.

Condition obesity
Sponsor Medifast, Inc.
Start date March 2008
End date March 2015
Trial size 332 participants
Trial identifier NCT01021917, 20071961, MED013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Those participating in weight loss programs other than Medifast Direct or Take Shape For Life.
Those using Medifast meal replacement products for weight loss while working closely with a Take Shape For Life certified Health Coach.
Those using Medifast meal replacement products specifically for weight loss that were purchased directly from the company and individually monitored by the customer.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
To evaluate potential predictors of successful weight loss & maintenance of weight loss.
time frame: 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.
time frame: 4 months, 16 months, and at 5y follow-up
To explore potential differences between subgroups in change in body weight and attrition.
time frame: 4 months, 16 months, and at 5y follow-up

Eligibility Criteria

Male or female participants from 18 years up to 69 years old.

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

Additional Information

Official title Weight Loss & Maintenance of Weight Loss Tracking Study (SUCCESS Tracking Study)
Principal investigator Lisa M Davis, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Medifast, Inc..