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

This study has been completed.
Sponsor:
Information provided by:
Medifast, Inc.
ClinicalTrials.gov Identifier:
NCT01011491
First received: November 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 10, 2009
November 10, 2009
March 2008
September 2009   (final data collection date for primary outcome measure)
Weight change (in kilograms) from week 0 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Satiety using a visual analog scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in Inflammation represented by C-reactive protein [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
  • Change in Oxidative Stress represented by urine lipid peroxides [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
  • Blood Pressure change [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
  • Change in Pulse [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in percent body fat (a measure representing a change in body composition) [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
  • Change in Blood lipids [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
  • Change in lean muscle mass (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
  • Change in Waist circumference (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
  • Change in Visceral Fat Rating (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • 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.
  • 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.
  • Experimental: Medifast 5 & 1 Plan
    Medifast's 5 & 1 Plan is a meal replacement plan for weight loss and weight maintenance.
    Intervention: Other: Medifast 5 & 1 Plan for weight loss and weight maintenance
  • 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.
    Intervention: Other: Food-based diet plan for weight loss and weight maintenance

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011491
MED014, 20080292
No
Lisa M. Davis, PhD, PA-C, CNS, LDN/ Vice President, Research & Development, Medifast, Inc.
Medifast, Inc.
Not Provided
Principal Investigator: Lisa M Davis, PhD, PA-C Medifast, Inc.
Medifast, Inc.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP