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

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02635698
• Collaborator: TKL Research, Inc. (Industry)
• Enrollment: 330
• Locations: 9
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 36.7
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Optifast; Other: Food-Based	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Opti-WIN: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percent weight change [26 weeks]

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

2. Percent weight change [52 weeks]

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

Secondary Outcome Measures

1. Ability to meet weight goals [52 weeks]

   Percentage of subjects meeting short- and long-term weight loss goals

2. Change in anthropometrics [52 weeks]

   change in BMI in kg/m^2 from baseline to 52 weeks

3. Change in cardiometabolic outcomes [52 weeks]

   Change in 10-year cardiovascular risk score (% likelihood to develop CVD in 10 years)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Premier Health	Anchorage	Alaska	United States	99503
2	Alexian Brothers Weight Loss Solutions	Schaumburg	Illinois	United States	60794
3	University of Michigan Health System	Ann Arbor	Michigan	United States	48106
4	Brody School of Medicine, East Carolina University	Greenville	North Carolina	United States	27834
5	Wake Forest School of Medicine	Winston-Salem	North Carolina	United States	27401
6	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio	United States	44718
7	Central Ohio Nutrition Center, Inc.	Gahanna	Ohio	United States	43230
8	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
9	Houston Center for Clinical Research	Sugar Land	Texas	United States	77479

Sponsors and Collaborators

• Nestlé
• TKL Research, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT02635698
• Other Study ID Numbers: 14.21.CLI
• First Posted: Dec 21, 2015
• Last Update Posted: Nov 13, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Body Weight

Study Results

No Results Posted as of Nov 13, 2017