Clinical trial NCT02635698: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
Official title: Opti-WIN: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: TKL Research, Inc.
First posted: 2015-12-21
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percent weight change
timeFrame: 26 weeks
measure: Percent weight change
timeFrame: 52 weeks
Secondary outcomes:
measure: Ability to meet weight goals
timeFrame: 52 weeks
measure: Change in anthropometrics
timeFrame: 52 weeks
measure: Change in cardiometabolic outcomes
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Premier Health
state: Alaska
city: Schaumburg
country: United States
facility: Alexian Brothers Weight Loss Solutions
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Greenville
country: United States
facility: Brody School of Medicine, East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Nutrition Center, Inc.
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Sugar Land
country: United States
facility: Houston Center for Clinical Research
state: Texas
Study officials:
References:
citation: 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.