Clinical trial

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

Invitation only · Not applicable · 1 countries · Registry ID NCT07268417

Invitation onlyNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity & Overweight

Full registry criteria

Inclusion Criteria: * patient population ages 20-75 with a body mass index (BMI) \>/= 30 who have had a primary care visit within the past 18 months Exclusion Criteria: * history of bariatric surgery, current pregnancy and post-partum within 180 days, current cancer diagnosis or cognitive impairment diagnosis

Treatments and study arms

ACTIVATE OC

Other

Offering of Shared Medical Appointments for Obesity Treatment

Primary outcomes

Weight LossMeasured at baseline, every 6 months during the intervention, and 6 months post-intervention.

Change in body weight as measured in kg compared to baseline weight.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cleveland Clinic🇺🇸 Cleveland, Ohio, United States