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

Obesity Clinical Trial

— Opti-WIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635698
• Other study ID #: 14.21.CLI
• Status: Completed
• Phase: N/A
• First received: December 11, 2015
• Last updated: November 9, 2017
• Start date: November 2015
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

Other:
• Optifast
medically-supervised weight management program
• Food-Based
low-energy, low-fat diet

Locations

Country	Name	City	State
United States	Alaska Premier Health	Anchorage	Alaska
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio
United States	Central Ohio Nutrition Center, Inc.	Gahanna	Ohio
United States	Brody School of Medicine, East Carolina University	Greenville	North Carolina
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Alexian Brothers Weight Loss Solutions	Schaumburg	Illinois
United States	Houston Center for Clinical Research	Sugar Land	Texas
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	TKL Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight change	Percent change in body weight between Initial Visit/Baseline and 26 weeks	26 weeks
Primary	Percent weight change	Percent change in body weight between Initial Visit/Baseline and 52 weeks	52 weeks
Secondary	Ability to meet weight goals	Percentage of subjects meeting short- and long-term weight loss goals	52 weeks
Secondary	Change in anthropometrics	change in BMI in kg/m^2 from baseline to 52 weeks	52 weeks
Secondary	Change in cardiometabolic outcomes	Change in 10-year cardiovascular risk score (% likelihood to develop CVD in 10 years)	52 weeks