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

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ClinicalTrials.gov Identifier: NCT01011491
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:
Medifast, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Other: Medifast 5 & 1 Plan for weight loss and weight maintenance Other: Food-based diet plan for weight loss and weight maintenance Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Medifast's 5 & 1 Program Compared to a Food-based Diet After a Period of Weight Loss and Weight Maintenance
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Weight change (in kilograms) from week 0 [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Satiety using a visual analog scale [ Time Frame: 16 weeks ]
  2. Change in Inflammation represented by C-reactive protein [ Time Frame: 16 and 40 weeks ]
  3. Change in Oxidative Stress represented by urine lipid peroxides [ Time Frame: 16 and 40 weeks ]
  4. Blood Pressure change [ Time Frame: 16 and 40 weeks ]
  5. Change in Pulse [ Time Frame: 16 and 40 weeks ]
  6. 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 ]
  7. Change in percent body fat (a measure representing a change in body composition) [ Time Frame: 16 and 40 weeks ]
  8. Change in Blood lipids [ Time Frame: 16 and 40 weeks ]
  9. Change in lean muscle mass (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ]
  10. Change in Waist circumference (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ]
  11. Change in Visceral Fat Rating (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011491


Locations
United States, Maryland
Medifast, Inc.
Owings Mills, Maryland, United States, 21117
Sponsors and Collaborators
Medifast, Inc.
Investigators
Principal Investigator: Lisa M Davis, PhD, PA-C Medifast, Inc.

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa M. Davis, PhD, PA-C, CNS, LDN/ Vice President, Research & Development, Medifast, Inc.
ClinicalTrials.gov Identifier: NCT01011491     History of Changes
Other Study ID Numbers: MED014
20080292 ( Other Identifier: Western Institutional Review Board )
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009

Keywords provided by Medifast, Inc.:
Obesity
Weight loss
meal replacements
inflammation
oxidative stress
visceral fat