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
  Purpose

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 Intervention
Obesity
Other: Medifast 5 & 1 Plan for weight loss and weight maintenance
Other: Food-based diet plan for weight loss and weight maintenance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medifast, Inc.:

Primary Outcome Measures:
  • Weight change (in kilograms) from week 0 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Publications:

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
Study First Received: November 10, 2009
Last Updated: November 10, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014