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

NCT02835092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2019-01-22

Study results available
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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.

Conditions

Interventions

OTHER

Take Shape For Life Program

The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 \& 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.

OTHER

Medifast Direct Program

The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 \& 2 \& 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.

OTHER

Self-directed Control

The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • Medifast, Inc.

    lead INDUSTRY

Principal Investigators

  • Chad Cook, PhD · Biofortis Innovation Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835092 on ClinicalTrials.gov