Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories

November 10, 2009 updated by: Medifast, Inc.

Efficacy of Medifast's 5 & 1 Program Compared to a Food-based Diet After a Period of Weight Loss and Weight Maintenance

Portion-controlled meal replacements have been shown to be an effective weight control strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the effect of Medifast's 5 & 1 program compared to an food-based diet plan of equal calories on the following indices: weight loss and maintenance of weight loss, satiety during weight loss, changes in biochemical markers of inflammation and oxidative stress following weight loss, and compliance and retention rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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

  • United States
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Medifast, Inc.

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult males and females (age between 18 and 65)
  • Obese (BMI >=30.0 kg/m2 and <50.0 kg/m2)
  • Non-smokers
  • No known food allergies to wheat, gluten, soy or nuts
  • <14 alcoholic beverages per week
  • Willing and able to give informed consent
  • Not currently using appetite-affecting medications (e.g SSRIs, steroids, Ritalin)
  • Not pregnant or lactating
  • Primary care physician's permission for weight loss, normal labs and electrocardiogram (EKG) within past 1 year

Exclusion Criteria:

  • Actively dieting
  • Eating Attitudes Test (EAT) > 30
  • Chronic uncontrolled health problems (not including obesity or diabetes)
  • Pacemaker or other internal electronic medical device
  • Schizophrenia, history of bipolar disorder, current Major Depressive Disorder
  • Dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines)
  • Cognitive impairment severe enough to preclude informed consent
  • Taking weight loss or appetite-suppressant medications
  • Taking appetite affecting medications (e.g. SSRIs, steroids, Ritalin)
  • Food allergies to wheat, gluten, soy, or nuts
  • Pregnant or lactating

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
Experimental: Medifast 5 & 1 Plan
Medifast's 5 & 1 Plan is a meal replacement plan for weight loss and weight maintenance.
Other: Medifast 5 & 1 Plan for weight loss and weight maintenance
Medifast's 5 & 1 Plan is a meal replacement program for weight loss that uses 5 Medifast meals and 1 self-prepared meal. The weight maintenance plan incorporates 3-5 Medifast meals as well as a certain amount of food from all other food groups.
Active Comparator: Food-based
The food-based arm followed a meal plan of self-selected foods that provided the same number of calories as the Medifast 5 & 1 plan.
Other: Food-based diet plan for weight loss and weight maintenance
The food-based group was provided a meal plan for weight loss based on the guidelines of the USDA Food Guide Pyramid providing the same number of calories as the Medifast 5 & 1 Plan. Weight maintenance calories were calculated and participants were provided meal plans from the USDA Food Guide Pyramid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change (in kilograms) from week 0
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Satiety using a visual analog scale
Time Frame: 16 weeks
16 weeks
Change in Inflammation represented by C-reactive protein
Time Frame: 16 and 40 weeks
16 and 40 weeks
Change in Oxidative Stress represented by urine lipid peroxides
Time Frame: 16 and 40 weeks
16 and 40 weeks
Blood Pressure change
Time Frame: 16 and 40 weeks
16 and 40 weeks
Change in Pulse
Time Frame: 16 and 40 weeks
16 and 40 weeks
Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms)
Time Frame: 24 weeks
24 weeks
Change in percent body fat (a measure representing a change in body composition)
Time Frame: 16 and 40 weeks
16 and 40 weeks
Change in Blood lipids
Time Frame: 16 and 40 weeks
16 and 40 weeks
Change in lean muscle mass (a measure representing change in body composition)
Time Frame: 16 and 40 weeks
16 and 40 weeks
Change in Waist circumference (a measure representing change in body composition)
Time Frame: 16 and 40 weeks
16 and 40 weeks
Change in Visceral Fat Rating (a measure representing change in body composition)
Time Frame: 16 and 40 weeks
16 and 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medifast, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2009

Last Update Submitted That Met QC Criteria

November 10, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED014
  • 20080292 (Other Identifier: Western Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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