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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Optifast; Other: Food-Based

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Premier Health
  • Illinois
    • Schaumburg, Illinois, United States, 60794
      • Alexian Brothers Weight Loss Solutions
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan Health System
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Brody School of Medicine, East Carolina University
    • Winston-Salem, North Carolina, United States, 27401
      • Wake Forest School of Medicine
  • Ohio
    • Canton, Ohio, United States, 44718
      • Neuro-Behavioral Clinical Research, Inc.
    • Gahanna, Ohio, United States, 43230
      • Central Ohio Nutrition Center, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Texas
    • Sugar Land, Texas, United States, 77479
      • Houston Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group, Optifast; OPTIFAST, medically supervised weight-management program	Other: Optifast; medically-supervised weight management program
Active Comparator: Control group, Low-energy, low-fat; Food-based program, current standard of care for weight management	Other: Food-Based; low-energy, low-fat diet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nestlé
• Collaborators: TKL Research, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: 14.21.CLI