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

Not Applicable

Completed

• Conditions: Obesity

• 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

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Alaska Premier Health; 🇺🇸 Anchorage, Alaska, United States

Alexian Brothers Weight Loss Solutions; 🇺🇸 Schaumburg, Illinois, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Brody School of Medicine, East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

Neuro-Behavioral Clinical Research, Inc.; 🇺🇸 Canton, Ohio, United States

Central Ohio Nutrition Center, Inc.; 🇺🇸 Gahanna, Ohio, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Houston Center for Clinical Research; 🇺🇸 Sugar Land, Texas, United States