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).

Clinical Study Identifier: TX4740

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.

Contact research investigator to learn more about this study by filling out the form below.

To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: Lifestyle Modification and Medication for Weight Loss
I am hoping to hear back from you and discuss details of the study

By clicking "Contact Research Team", your contact information will be sent directly to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.