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

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