Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
NCT ID: NCT02635698
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
330 participants
INTERVENTIONAL
2015-11-30
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group, Optifast
OPTIFAST, medically supervised weight-management program
Optifast
medically-supervised weight management program
Control group, Low-energy, low-fat
Food-based program, current standard of care for weight management
Food-Based
low-energy, low-fat diet
Interventions
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Optifast
medically-supervised weight management program
Food-Based
low-energy, low-fat diet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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TKL Research, Inc.
INDUSTRY
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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Alaska Premier Health
Anchorage, Alaska, United States
Alexian Brothers Weight Loss Solutions
Schaumburg, Illinois, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Brody School of Medicine, East Carolina University
Greenville, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Central Ohio Nutrition Center, Inc.
Gahanna, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Houston Center for Clinical Research
Sugar Land, Texas, United States
Countries
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References
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Ard JD, Lewis KH, Rothberg A, Auriemma A, Coburn SL, Cohen SS, Loper J, Matarese L, Pories WJ, Periman S. Effectiveness of a Total Meal Replacement Program (OPTIFAST Program) on Weight Loss: Results from the OPTIWIN Study. Obesity (Silver Spring). 2019 Jan;27(1):22-29. doi: 10.1002/oby.22303. Epub 2018 Nov 13.
Other Identifiers
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14.21.CLI
Identifier Type: -
Identifier Source: org_study_id