Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
- Conditions
- Obesity
- Interventions
- Other: OptifastOther: Food-Based
- Registration Number
- NCT02635698
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group, Optifast Optifast OPTIFAST, medically supervised weight-management program Control group, Low-energy, low-fat Food-Based Food-based program, current standard of care for weight management
- Primary Outcome Measures
Name Time Method Percent weight change 52 weeks Percent change in body weight between Initial Visit/Baseline and 52 weeks
- Secondary Outcome Measures
Name Time Method Ability to meet weight goals 52 weeks Percentage of subjects meeting short- and long-term weight loss goals
Change in anthropometrics 52 weeks change in BMI in kg/m\^2 from baseline to 52 weeks
Change in cardiometabolic outcomes 52 weeks Change in 10-year cardiovascular risk score (% likelihood to develop CVD in 10 years)
Trial Locations
- Locations (9)
Brody School of Medicine, East Carolina University
🇺🇸Greenville, North Carolina, United States
Alexian Brothers Weight Loss Solutions
🇺🇸Schaumburg, Illinois, United States
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Central Ohio Nutrition Center, Inc.
🇺🇸Gahanna, Ohio, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸Canton, Ohio, United States
Houston Center for Clinical Research
🇺🇸Sugar Land, Texas, United States
Alaska Premier Health
🇺🇸Anchorage, Alaska, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States