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Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet | Clinical Trials | Clareo Health

COMPLETEDNA

Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet

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

NCT02835092•Medifast, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
+10 more criteria

Locations (1)

Biofortis Innovation Services

Addison, Illinois, United States

Key Dates

Start Date

July 1, 2016

Primary Completion Date

February 1, 2017

Completion Date

February 1, 2017

Last Updated

January 22, 2019

Enrollment

198

ACTUAL participants

Conditions

OverweightObesity

Interventions

Take Shape For Life Program

OTHER

Medifast Direct Program

OTHER

Self-directed Control

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet

Inclusion Criteria

Exclusion Criteria

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