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

NCT02835092 | Completed Results

• 1 other identifier: BIO-1607 (MED 019)
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Body Weight Change

  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

Study Arms (3)

Self-directed Control

ACTIVE COMPARATOR

Other: Self-directed Control

Take Shape For Life Program

EXPERIMENTAL

Other: Take Shape For Life Program

Medifast Direct Program

EXPERIMENTAL

Other: Medifast Direct Program

Interventions

Take Shape For Life Program OTHER

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.

Take Shape For Life Program

Medifast Direct Program OTHER

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.

Medifast Direct Program

Self-directed Control OTHER

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

Self-directed Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medifast, Inc.: lead
• BioFortis: collaborator

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Linda Arterburn, VP Scientific & Clinical Affairs
• Organization: Medifast

linda.arterburn@medifastinc.com

443-379-5191

Study Officials

• Chad Cook, PhD

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 15, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 22, 2019
• Results First Posted: January 7, 2019

Record last verified: 2019-01

Locations

US (1)