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

NCT07268417 | Enrolling By Invitation

• 2 other identifiers: 24-1147PCORI Funded
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight

Keywords

Shared Medical Appointment Obesity Care; Intensive Lifestyle Treatment for Obesity; ACTIVATE OC

Outcome Measures

Primary Outcomes (1)

• Weight Loss

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

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

Secondary Outcomes (21)

• Weight Loss

  Baseline, every 6 months during intervention, and 6 months post-intervention

• Outcome measure type: Reach

  Timing and frequency of measurement is every 3 months.

• Outcome measure type: Effectiveness

  Hospitalizations and emergency department visits - every 6 months

• Outcome measure type: Effectiveness

  Baseline and end of intervention

• Patient Reported Outcomes- PROMIS10 Global Health Survey

  Baseline, every month during the SMA intervention and 6 months post-intervention.

Interventions

ACTIVATE OC OTHER

Offering of Shared Medical Appointments for Obesity Treatment

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who see a primary care provider within one of the Cleveland Clinic Health System Northeast Ohio 56 primary care sites, that meet the inclusion/exclusion criteria.

You may qualify if:

• patient population ages 20-75 with a body mass index (BMI) \>/= 30 who have had a primary care visit within the past 18 months

You may not qualify if:

• history of bariatric surgery, current pregnancy and post-partum within 180 days, current cancer diagnosis or cognitive impairment diagnosis

Sponsors & Collaborators

• Anita Misra-Hebert: lead
• Patient-Centered Outcomes Research Institute: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

• Bacon JG, Scheltema KE, Robinson BE. Fat phobia scale revisited: the short form. Int J Obes Relat Metab Disord. 2001 Feb;25(2):252-7. doi: 10.1038/sj.ijo.0801537.

  PMID: 11410828 BACKGROUND

• Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.

  PMID: 19543809 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Befort CA, VanWormer JJ, Desouza C, Ellerbeck EF, Gajewski B, Kimminau KS, Greiner KA, Perri MG, Brown AR, Pathak RD, Huang TT, Eiland L, Drincic A. Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial. JAMA. 2021 Jan 26;325(4):363-372. doi: 10.1001/jama.2020.25855.

  PMID: 33496775 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Staff, Department of Internal Medicine; Director, Healthcare Delivery and Implementation Science Center

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)