Lifestyle Modification and Medication for Weight Loss
Brief Description Of Study
We are seeking participants for a long-term weight loss trial that includes a behavioral weight loss program and the possibility of receiving an FDA-approved weight loss medication. The full study will last 1 year (52 weeks).
Detailed Study Description
We are conducting a study to investigate the effectiveness of a lifestyle modification program for weight loss recommended by the Centers for Medicare and Medicaid Services (CMS). It provides 21 sessions of diet and exercise counseling over 12 months, provided by a doctor, nurse practitioner, or registered dietitian (RD) working in consultation with the former providers. As part of this study we also are testing the effectiveness of an FDA-approved weight loss medication called liraglutide, also known as Saxenda. Saxenda is a once-daily self-administered, subcutaneous (beneath the skin) injection that may reduce appetite and help overweight or obese adults lose weight and keep it off. Saxenda is currently FDA-approved for chronic weight management, when combined with a reduced-calorie diet and increased physical activity. Another part of the study will examine whether the combination of lifestyle counseling with a portion-controlled diet leads to greater weight loss. The portion-controlled diet will consist of meal replacements in the form of liquid shakes and pre-packaged meals. All participants, regardless of group assignment, will receive the same program of diet, physical activity, and behavior therapy, as currently recommended by the CMS. However, approximately one third of the participants will be randomly assigned to receive CMS-recommended lifestyle counseling alone (CMS-Alone), one third will be randomly assigned to receive CMS counseling plus liraglutide (CMS-Liraglutide), and one third will be randomly assigned to CMS counseling with liraglutide plus a portion-controlled diet (Multi-Component Intervention).
Additional Information About The Study
Eligible individuals are men and women who have a body mass index of 30 kg/m2 or more and are free of types 1 or 2 diabetes. Other medical conditions also may prevent participation. There are no fees for participating in this study. Individuals will not be paid to participate in the study but will receive a total of $210, ($10 for each of the 21 lifestyle counseling visits) to help cover their travel costs. You also will receive $50 for each of the week 24 and week 52 outcome assessments, which are longer visits (a total of $100 if you complete both outcome assessments). Please contact the study team if you are interested in participating, and we will contact you to conduct a phone screen.