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ObesityNCT01211301

Medifast 5 & 1 Plan

A study testing Food-based, Reduced Energy Diet Plan and Medifast 5 & 1 Plan in people with Obesity and Body Weight, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the effectiveness of the Medifast 5 \& 1 Plan to a food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a 26-week weight-loss phase and a 26-week weight-maintenance phase. Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Body Weight, Weight Loss
What is being tested?
Food-based, Reduced Energy Diet Plan and Medifast 5 & 1 Plan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
Oct 2010to Apr 2013
Phase
Interventional
Are there results?
None posted in the registry

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 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI 35-50 kg/m2
  • Interested in weight loss
  • Computer with internet access
  • Any race or ethnicity
  • Fasting glucose <126 mg/dL at screening

Who cannot join

  • Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
  • Weight loss or gain of >5% body weight in past 6 months for any reason except post-partum weight loss.
  • Currently taking any medication that suppresses or stimulates appetite.
  • History of prior surgical procedure for weight control or liposuction.
  • Current smoker or quit smoking less than 6 months prior.
  • Any major disease, including:
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  • Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
  • Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
  • Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class >2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
  • Uncontrolled hypertension: systolic blood pressure >160 mm Hg or diastolic blood pressure >95 mm Hg on treatment.
  • Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
  • Active kidney disease.
  • Lung disease: chronic obstructive airway disease requiring use of oxygen.
  • Diagnosed diabetes (type 1 or 2), fasting hyperglycemia (blood glucose >126 mg/dL), or use of any anti-diabetic medications.
  • Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
  • A score on the Brief Symptom Inventory (BSI) (Derogatis \& Melisaratos, 1983) that exceeds the 90th percentile.
  • History of or current eating disorders, or an Eating Attitudes Test (EAT 40) score >30.
  • Active food allergies, particularly to wheat, gluten, soy or nuts.
  • Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.
  • Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable.
  • No regular source of health care.
  • Any active use of illegal or illicit drugs or history of illegal or illicit drug utilization within past year
  • Excessive alcohol intake, either acute or chronic defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff.
  • Willing to limit alcohol intake to zero
  • Pregnancy and childbearing: currently pregnant or less than 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take adequate contraceptive measures if potentially fertile.
  • Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham Division of Preventive Medicine

    Birmingham, Alabama, 35205

Other trials in United States

About this study

Official title: Randomized Controlled Trial of the Medifast 5 & 1 Plan

The purpose of this study is to compare the effectiveness of the Medifast 5 \& 1 Plan to a food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a 26-week weight-loss phase and a 26-week weight-maintenance phase. 120 participants will be enrolled, with 60 randomized to the Medifast 5 \& 1 Plan and 60 randomized to food-based, reduced-energy diet plan. Multiple measures will be performed at baseline, 26 weeks, and 52 weeks, including anthropometry, body composition, blood pressure, blood assays, and appetite sensations.

Being tested
Food-based, Reduced Energy Diet Plan, Medifast 5 & 1 Plan
Keywords
obesity, overweight, weight loss, randomized controlled trial, Medifast
Medical subject headings
Obesity, Body Weight, Weight Loss, Overweight, Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food-based, Reduced Energy Diet PlanBehavioural

    Control participants will be provided with a 1000-kcal/d meal plan based on regular foods selected and procured by participants. Food lists, sample menus, and portion size references will be provided.

  • Medifast 5 & 1 PlanOther

    Participants randomized to the Medifast group will enroll online in the Medifast 5 \& 1 Plan. This plan consists of 5 portion-controlled, nutritionally-balanced Medifast Meals plus one Lean \& Green Meal each day. Medifast Meals come in individual packets that are mixed with water and microwaved or refrigerated, and are available in a wide variety of foods and flavors. There are >70 Medifast Meal choices, and Medifast Meals may be used interchangeably, so any five Medifast Meals can be chosen for the 5 \& 1 Plan. The Medifast 5 \& 1 Plan provides approximately 800 to 1,000 kcal/d. The Lean \& Green Meal consists of a lean meat plus salad and/or vegetables selected by the participant. Intervention participants will have online access to Medifast dietitians, Medifast trainers, a Medifast message board, and a Medifast chat room, allowing them to interact with others on the Medifast 5 \& 1 Plan.

Study groups in NCT01211301
Study groupRoleWhat they receive
Food-based, Reduced Energy Diet PlanActive comparatorNot described
Receives: Behavioral: Food-based, Reduced Energy Diet Plan
Medifast 5 & 1 PlanExperimentalNot described
Receives: Other: Medifast 5 & 1 Plan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    Measured: 26 and 52 weeks

Secondary outcomes (12)

  1. Waist circumference

    Measured: 26 and 52 weeks

  2. Body composition as measured by bioelectrical impedence (BIA)

    Measured: 26 and 52 weeks

  3. Body mass index

    Measured: 26 and 52 weeks

  4. Low-density lipoprotein cholesterol (LDL)

    Measured: 26 and 52 weeks

  5. High-density lipoprotein cholesterol (HDL)

    Measured: 26 and 52 weeks

  6. Triglycerides

    Measured: 26 and 52 weeks

  7. Glucose

    Measured: 26 and 52 weeks

  8. Liver function tests

    Measured: 26 and 52 weeks

  9. High-sensitivity C-reactive protein (hs-CRP)

    Measured: 26 and 52 weeks

  10. Lipid hydroperoxides

    Measured: 26 and 52 weeks

  11. Blood pressure

    Measured: 26 and 52 weeks

  12. Appetite/satiety measures

    Measured: 26 and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionFeb 2012
  4. Study completionApr 2013

Resources

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01211301
Sponsor's protocol ID
F100625001
Status last verified
Jun 2013
First submitted
28 Sep 2010
Last updated
19 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Shikany JM, Thomas AS, Beasley TM, Lewis CE, Allison DB. Randomized controlled trial of the Medifast 5 & 1 Plan for weight loss. Int J Obes (Lond). 2013 Dec;37(12):1571-8. doi: 10.1038/ijo.2013.43. Epub 2013 Apr 9.

    PubMed 23567927

Questions about this trial

What is this clinical trial studying?

A study testing Food-based, Reduced Energy Diet Plan and Medifast 5 & 1 Plan in people with Obesity and Body Weight, run by University of Alabama at Birmingham 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 5 inclusion and 26 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 19 Jun 2013. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: 26 and 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211301, which also lists 1 linked publication.

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 19 Jun 2013.

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