A Randomized, Controlled, 3-Arm Clinical Trial to Assess Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet

Medifast, Inc.1 site in 1 country198 target enrollmentJuly 2016

ConditionsOverweight Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overweight
Sponsor: Medifast, Inc.
Enrollment: 198
Locations: 1
Primary Endpoint: Body Weight Change
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study evaluates the effects of two commercially available weight loss programs, the TSFL and the MEDD programs, each compared to a self-directed control diet, on changes in body weight over a 16-week weight loss phase, in apparently healthy overweight and obese men and women.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

February 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medifast, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant is judged by the Clinical Investigator to be in good health on the basis of medical history and screening laboratory assessments.
•Participant has a BMI of 27.0 to 42.0 kg/m2 at start of intervention.
•Participant has no plans to change smoking habits during the study period.
•Participant is willing and able to comply with the visit schedule.
•Participant is willing to modify their physical activity level in accordance with recommendations provided with each group.
•In the Clinical Investigator's opinion, participant has interest in losing weight, and is ready and willing to do so.
•Participant is willing/able to follow assigned plan and adhere to food and beverage consumption guidelines for the duration of the study period.
•Participant has access to the internet via a computer, tablet, and/or smart phone.
•Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Clinical Investigators.

Exclusion Criteria

•Participant has an abnormal laboratory test result of clinical significance at the screening visit, at the discretion of the Clinical Investigator.
•Participant has had a weight loss or gain \>5% in the 6 months prior to the screening visit except in the case of post-partum weight loss.
•Participant has extreme dietary habits, including vegetarianism, in the judgment of the Clinical Investigator.
•Participant has used medications, products, supplements, and/or programs/diets intended to alter body weight within 6 months of the screening visit.
•Participant has used medications which are known to stimulate or suppress appetite, and/or alter body weight but which are taken for other indications, will be allowed as long as the dose has remained stable for the past 6 months.
•Participant has used thyroid hormones, except stable-dose replacement therapy for ≥2 months prior to the screening visit.
•Participant has used Coumadin® (warfarin), and/or medications that may influence lipids and/or blood pressure, except stable-dose medications for 1 month prior to the screening visit.
•Participant has used medications that may influence carbohydrate metabolism, including but not limited to hypoglycemic medications and systemic (intravenous, intramuscular, or oral) corticosteroids within 1 month of the screening visit.
•Participant has used lithium within 1 month of the screening visit.
•Participant has a history of any surgery or liposuction for weight reducing purposes.

Outcomes

Primary Outcomes

Body Weight Change

Time Frame: 16 weeks

Body weight (in gown, without shoes) was measured at each clinic visit on a medical quality digital scale (Health-o-meter 349KLX, Pelstar, McCook, IL) following a 10-14-hr fast. The relevant time points to determine body weight change were baseline and 16 weeks. The value for body weight at 16 weeks minus the value at baseline was the calculation used to determine body weight change.