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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Food-based diet plan for weight loss and weight maintenance; Other: Medifast 5 & 1 Plan for weight loss and weight maintenance

• Registration Number: NCT01011491
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Last Update Submitted: 2009-11-10
• Study First Posted: 2009-11-11
• Last Update Posted: 2009-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food-based	Food-based diet plan for weight loss and weight maintenance	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.
Medifast 5 & 1 Plan	Medifast 5 & 1 Plan for weight loss and weight maintenance	Medifast's 5 \& 1 Plan is a meal replacement plan for weight loss and weight maintenance.

Primary Outcome Measures

Name	Time	Method
Weight change (in kilograms) from week 0	16 weeks

Secondary Outcome Measures

Name	Time	Method
Satiety using a visual analog scale	16 weeks
Change in Inflammation represented by C-reactive protein	16 and 40 weeks
Change in Oxidative Stress represented by urine lipid peroxides	16 and 40 weeks
Blood Pressure change	16 and 40 weeks
Change in Pulse	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)	24 weeks
Change in percent body fat (a measure representing a change in body composition)	16 and 40 weeks
Change in Blood lipids	16 and 40 weeks
Change in lean muscle mass (a measure representing change in body composition)	16 and 40 weeks
Change in Waist circumference (a measure representing change in body composition)	16 and 40 weeks
Change in Visceral Fat Rating (a measure representing change in body composition)	16 and 40 weeks

Trial Locations

Locations (1)

Medifast, Inc.; 🇺🇸 Owings Mills, Maryland, United States