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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optifast
Food-Based
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alaska Premier Health
  • Alexian Brothers Weight Loss Solutions
  • University of Michigan Health System
  • Brody School of Medicine, East Carolina University
  • Wake Forest School of Medicine
  • Neuro-Behavioral Clinical Research, Inc.
  • Central Ohio Nutrition Center, Inc.
  • Thomas Jefferson University
  • Houston Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group, Optifast

Control group, Low-energy, low-fat

Arm Description

OPTIFAST, medically supervised weight-management program

Food-based program, current standard of care for weight management

Outcomes

Primary Outcome Measures

Percent weight change
Percent change in body weight between Initial Visit/Baseline and 26 weeks
Percent weight change
Percent change in body weight between Initial Visit/Baseline and 52 weeks

Secondary Outcome Measures

Ability to meet weight goals
Percentage of subjects meeting short- and long-term weight loss goals
Change in anthropometrics
change in BMI in kg/m^2 from baseline to 52 weeks
Change in cardiometabolic outcomes
Change in 10-year cardiovascular risk score (% likelihood to develop CVD in 10 years)

Full Information

First Posted
December 11, 2015
Last Updated
November 9, 2017
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
TKL Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02635698
Brief Title
Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
Acronym
Opti-WIN
Official Title
Opti-WIN: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
TKL Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group, Optifast
Arm Type
Experimental
Arm Description
OPTIFAST, medically supervised weight-management program
Arm Title
Control group, Low-energy, low-fat
Arm Type
Active Comparator
Arm Description
Food-based program, current standard of care for weight management
Intervention Type
Other
Intervention Name(s)
Optifast
Intervention Description
medically-supervised weight management program
Intervention Type
Other
Intervention Name(s)
Food-Based
Intervention Description
low-energy, low-fat diet
Primary Outcome Measure Information:
Title
Percent weight change
Description
Percent change in body weight between Initial Visit/Baseline and 26 weeks
Time Frame
26 weeks
Title
Percent weight change
Description
Percent change in body weight between Initial Visit/Baseline and 52 weeks
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Ability to meet weight goals
Description
Percentage of subjects meeting short- and long-term weight loss goals
Time Frame
52 weeks
Title
Change in anthropometrics
Description
change in BMI in kg/m^2 from baseline to 52 weeks
Time Frame
52 weeks
Title
Change in cardiometabolic outcomes
Description
Change in 10-year cardiovascular risk score (% likelihood to develop CVD in 10 years)
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Alaska Premier Health
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Alexian Brothers Weight Loss Solutions
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60794
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Brody School of Medicine, East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Central Ohio Nutrition Center, Inc.
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Houston Center for Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30421863
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.
Results Reference
derived

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

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