870
Participants
Start Date
June 30, 2022
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
Online Lifestyle Behavioral Therapy
Participants will receive access to the WW™ digital application for the duration of their participation. The WW™ digital application can be accessed using a smartphone, tablet or personal computer and includes functions such as food journaling, progress charts, lifestyle coaching , ability to manually enter exercise data or link with a fitness tracking device, incentives for behavior change, recipes, and local restaurant recommendations using GPS. Over the course of 12 clinic visits with an obesity provider, participants will be prescribed a dietary plan based on the WW™ app and will be asked to journal dietary intake.
Phentermine Hydrochloride 8 MG
At the randomization visit, participants will be started on 8 mg PO daily of phentermine or placebo, with a recommendation to take the medication in the morning. They will be provided with detailed instructions on how to increase their dose of study drug over the subsequent weeks. After one week, participants will increase to 16 mg daily. After the second week, participants will further increase their dose to 24 mg daily and at the 1-month in-person follow-up, participants who tolerate the 24 mg dose will be maintained on this as the maximum daily dose for a total of 24 months. For participants who do not tolerate an escalation in medication dose due to side effects, adverse events, and/or elevations in blood pressure and/or heart rate, the study clinician may adjust the dose and/or delay dose escalation. Study clinicians will work with participants to achieve and sustain the maximum dose tolerated.
Atrium Health Wake Forest Baptist Weight Management Center, Winston-Salem
HealthPartners Institute, Saint Louis Park
UT Center for Obesity Medicine and Metabolic Performance, Bellaire
Kaiser Permanente Southern California, Los Angeles
Collaborators (1)
Johns Hopkins University
OTHER
Kaiser Permanente
OTHER
HealthPartners Institute
OTHER
The University of Texas Health Science Center, Houston
OTHER
Biomedical Research Institute of New Mexico
OTHER
WW International Inc
INDUSTRY
KVK-Tech, Inc.
UNKNOWN
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Wake Forest University Health Sciences
OTHER