Group Medical Appointments for Intensive Lifestyle Treatment for Obesity in Cleveland Clinic Primary Care Practices

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Anita Misra-Hebert
Study ID
NCT07268417
Status
Enrolling By Invitation

Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ACTIVATE OC — OTHER
    Offering of Shared Medical Appointments for Obesity Treatment

Study Details

In 2023, Cleveland Clinic was accepted into a national program, the Patient-Centered Outcomes Research Institute Health Systems Implementation Initiative (PCORI HSII) which aims to improve implementation of prior published PCORI-funded research evidence into real-world practice. The investigators first received funding to build organizational capacity to participate in health system implementation projects. This protocol describes activities for our first implementation project for which the investigators have received funding from the PCORI HSII program. The investigator's project seeks to expand the availability of shared medical appointments (SMAs) for obesity treatment in all 56 primary care practices of the Cleveland Clinic health system in Northeast Ohio. The proposed project, to be implemented as part of routine healthcare delivery, will adapt aspects of a prior study funded by the PCORI that generated evidence that group visits such as SMAs can help with obesity treatment. All primary care patients in Northeast Ohio with obesity (body mass index (BMI) \>/=30) and aged between 20 and 75 years will be potentially eligible for enrollment in the SMAs. Primary care providers will offer patients entry into the SMAs as part of usual clinical care during office visits. In addition, information about these SMAs will also be available to the patients through the "MyChart" patient portal in EPIC. Implementation of the SMAs will happen in three phases (pre-implementation, active implementation, and maintenance) over 42 months. During its implementation, the project intends to reach over 140,000 patients. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the SMAs. Electronic medical records and patient surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections. As this implementation project will be part of routine care delivery, the investigators emphasize that the risks (physical, psychological, social, legal, financial, or other) associated with participation in SMAs for obesity will not be greater than minimal or those posed by any SMAs as currently configured for the delivery of other healthcare services within the Cleveland Clinic healthcare system. The potential benefits associated with participation in these SMAs include weight loss, improvements in cardiovascular risk factors, and reduced utilization of acute healthcare services.

Key Dates

Start date
Dec 1, 2024
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
May 31, 2028

Study Design

Enrollment
3,600 participants (estimated)

Primary Outcome Measure

Weight Loss [ Time Frame: Measured at baseline, every 6 months during the intervention, and 6 months post-intervention. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195-

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