OverweightNCT02835092
Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet
A study testing Take Shape For Life Program and Medifast Direct Program in people with Overweight and Obesity, run by Medifast, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Take Shape For Life Program and Medifast Direct Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services
Addison, Illinois, 60101
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- Take Shape For Life Program, Medifast Direct Program, Self-directed Control
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take Shape For Life ProgramOther
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.
Medifast Direct ProgramOther
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.
Self-directed ControlOther
The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.
| Study group | Role | What they receive |
|---|---|---|
| Self-directed Control | Active comparator | Not described Receives: Other: Self-directed Control |
| Take Shape For Life Program | Experimental | Not described Receives: Other: Take Shape For Life Program |
| Medifast Direct Program | Experimental | Not described Receives: Other: Medifast Direct Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medifast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Chad Cook, PhD, Principal investigator, Biofortis Innovation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835092
- Sponsor's protocol ID
- BIO-1607 (MED 019)
- Status last verified
- Jan 2019
- First submitted
- 13 Jul 2016
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02835092
- Acronym / sponsor ID
- BIO-1607 (MED 019)
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Medifast, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- Jul 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Posted 7 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take Shape For Life ProgramThe 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 | Take Shape For Life Program |
| Medifast Direct ProgramThe 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 | Medifast Direct Program |
| Self-directed ControlThe Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans. | Other | Self-directed Control |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Cook, PhD principal investigator
Biofortis Innovation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take Shape For Life Program and Medifast Direct Program in people with Overweight and Obesity, run by Medifast, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight Change (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.