Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight

Study Overview
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Brief Summary
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Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program

Official Title
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Opti-WIN: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight

Conditions
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Obesity

Intervention / Treatment
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* Other: Optifast
* Other: Food-Based


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and females between 18 and 70 years Obese (BMI > 30 kg/m2 and 55 kg/m2) Non-smokers or smoking cessation > 6 months < 14 alcoholic beverages per week Willing and able to give informed consent Exclusion Criteria: Active participation in any weight loss program within previous 3 months Weight changes of > 5% body weight within previous 3 months Participated in an Optifast program within prior 5 years Prior bariatric surgery or liposuction Use of any medication prescribed for weight loss in the past 3 months Current major disease or GI disease that is poorly controlled (Crohn's, ulcerative colitis) Type 1 DM Current ESRD Current COPD Any major or active hepatic disease requiring inpatient or outpatient treatment History of acute pancreatitis in the past year Active cancer treatment in the past 2 years other than non-malignant skin cancers Uncontrolled hypertension (Blood pressure 160/100 or greater) Hemoglobin A1c > 10% Recent CV event in past 6 months Pregnancy, childbirth, or nursing within prior 6 months Eating Attitudes Test (EAT-26) > 30 Current major depressive disorder with Center for Epidemiological Studies Depression Scale-Revised (CESD-R) score > 16 Schizophrenia, history of bipolar disorder Recent hospitalization for psychiatric illness in past 6 months Dependence on alcohol or sedative-hypnotic drugs Intolerance or allergy to Optifast product Unable to read/speak English Orthopedic limitation preventing participation in regular physical activity Untreated thyroid disease, abnormal TSH, non on stable dose of hormone replacement for hyperthyroidism Major surgery defined as any surgical procedure that might require prolonged convalescence or limit participation in the program in any way Inability to complete the 7-day run-in satisfactorily

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Intervention group, Optifast<br>OPTIFAST, medically supervised weight-management program | Other: Optifast<br>* medically-supervised weight management program<br>|
| Active Comparator: Control group, Low-energy, low-fat<br>Food-based program, current standard of care for weight management | Other: Food-Based<br>* low-energy, low-fat diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight change | Percent change in body weight between Initial Visit/Baseline and 26 weeks | 26 weeks | 
| Percent weight change | Percent change in body weight between Initial Visit/Baseline and 52 weeks | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to meet weight goals | Percentage of subjects meeting short- and long-term weight loss goals | 52 weeks | 
| Change in anthropometrics | change in BMI in kg/m^2 from baseline to 52 weeks | 52 weeks | 
| Change in cardiometabolic outcomes | Change in 10-year cardiovascular risk score (% likelihood to develop CVD in 10 years) | 52 weeks |