- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02835092
Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet
January 7, 2019 updated by: Medifast, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Addison, Illinois, United States, 60101
- Biofortis Innovation Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
- Participant has a history or presence of clinically important gout, cardiac, renal, hepatic, endocrine (type 1 diabetes mellitus or type 2 diabetes mellitus that requires medication), pulmonary, biliary, pancreatic, or neurologic disorders.
- Participant has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa or binge eating) diagnosed by a health professional.
- Participant has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at screening visit.
- Participant has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Participant has elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
- Participant is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Participant has a recent history of (within 12 months of Visit 1; week -1) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks/week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Participant has a known allergy, sensitivity, or intolerance to the study foods or any ingredient(s) of the study diets (e.g., soy, gluten, wheat, lactose).
- Exposure to any non-registered drug product within 1 month prior to the screening visit.
- Participant has a condition the Clinical Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Experimental: 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.
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chad Cook, PhD, Biofortis Innovation Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
July 13, 2016
First Submitted That Met QC Criteria
July 13, 2016
First Posted (Estimate)
July 15, 2016
Study Record Updates
Last Update Posted (Actual)
January 22, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO-1607 (MED 019)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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