Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults
- Registration Number
- NCT02706067
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Body mass index (BMI) greater than or equal to (>/=) 30 kilograms per meter-squared (kg/m^2), or BMI >/= 28 kg/m^2 with risk factors of diabetes, hypertension, or hyperlipidemia, before weight loss
- Documented weight loss >/= 10% of initial body weight obtained with diet, with or without psychological therapy or orlistat
Exclusion Criteria
- Pregnant or lactating females
- History or presence of significant medical disorders
- Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes
- Pancreatic disease: pancreatic enzyme deficiency, history or current presence of pancreatitis
- Clinically significant abnormal clinical chemistry or hematology results
- Excessive alcohol intake
- Smoking cessation within the previous 6 months
- History or presence of cancer
- Administration of medicines known to alter body weight
- History or presence of cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Orlistat Orlistat Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight at Year 2 Baseline and Year 2 Percent Change from Baseline in Body Weight at Year 4 Baseline and Year 4
- Secondary Outcome Measures
Name Time Method Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria Every 6 months during Year 1, annually during Years 2 to 4 Eating Disorder Inventory (EDI) 2 Subscale and Total Score Baseline and Year 4 Hospital Anxiety and Depression (HAD) Subscale Score Baseline and Year 4 Number of Orlistat Capsules Taken During the Study Given up to three times per day for 4 years Duration of Orlistat Treatment During the Study Given up to three times per day for 4 years Waist-to-Hip Circumference Ratio Baseline and Year 4 Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters) Baseline and Year 4 Skinfold Thickness (Expressed in Millimeters) Baseline and Year 4 Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass) Baseline and Year 4 Number of Kilocalories Expended, Total and at Rest Baseline and Year 4