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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medifast 5 & 1 Plan<br>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<br>* 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.<br>|
| Active Comparator: Food-based<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change (in kilograms) from week 0 |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight loss, meal replacements, inflammation, oxidative stress, visceral fat