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



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:12/7/2016
Start Date:November 2015
End Date:April 2017

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

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


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
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Greenville, North Carolina 27834
Principal Investigator: Walter Pories, MD
Phone: 252-744-5249
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Anchorage, Alaska 99503
Principal Investigator: Sally Coburn, MSN
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Amy Rothberg, MD
Phone: 734-936-4375
University of Michigan Health System The University of Michigan is home to one of the...
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Canton, Ohio 44718
Principal Investigator: Shishuka Malhotra, MD
Phone: 330-493-1154
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Gahanna, Ohio 43230
Principal Investigator: Judy Loper, PhD, RD
Phone: 614-864-7225
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Serge Jabbour, MD
Phone: 215-955-1978
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Schaumburg, Illinois 60794
Principal Investigator: Anthony Auriemma, MD
Phone: 847-252-6099
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Sugarland, Texas 77479
Principal Investigator: Aparna Tamirisa, MD
Phone: 832-929-6221
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Winston-Salem, North Carolina 27157
Principal Investigator: Jamy Ard, MD
Phone: 336-716-5335
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