Group Medical Appointments for Intensive Lifestyle Treatment for Obesity in Cleveland Clinic Primary Care Practices (ACTIVATE OC)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity & Overweight
• Intervention / Treatment: Other: ACTIVATE OC

Detailed Description

The objective of this implementation effort is to optimize the availability of intensive lifestyle treatment of obesity in the adult population of patients who receive care within the Cleveland Clinic health system in Northeast Ohio primary care practices as part of routine clinical practice. Utilizing the group visit model from the evidence generated from the Befort et al Patient-Centered Outcomes Research (PCORI) funded study,(5) the investigators will significantly expand current health system obesity treatment resources and build on our model of SMAs led by multidisciplinary teams to deliver the intervention. Through a coordinated health system-wide implementation effort in all primary care practices, the investigators aim to improve the health of our patients with obesity through developing a successful obesity treatment program, improving upon current health system programs, with the goal of long-term impact in reducing patient comorbidities, cardiovascular risk, and promoting sustainable weight loss. The investigators propose to implement group visits for intensive lifestyle intervention for obesity utilizing the SMA model. Implementation of the Obesity SMAs will be in all 56 Cleveland Clinic primary care practices in Northeast Ohio.

Specific Aims

Aim 1. To prepare for implementation of Obesity Treatment SMAs across all Northeast Ohio Primary Care Practices (Pre-Implementation)

Pre-Implementation Phase (9 months)

• Adaptation of Obesity SMA Training Materials for Primary Care Providers with input from Continuous Improvement Specialists regarding practice change principles
• Delivery of Education Sessions, including topic of implementation outcomes
• Quantitative Assessment of Practice Variation in Obesity Treatment Patterns
• Qualitative Assessment of Barriers and Facilitators to Obesity Treatment at Primary Care Practice Level
• Creation of Clinical Decision Support Tool for SMA referral
• Creation of Patient and Employee Advisory Panel

Aim 2. To Implement Obesity Treatment SMAs across all Northeast Ohio Primary Care Practices (Active Implementation)

Active Implementation Phase (18 months)

• Implementation of Clinical Decision Support at Implementation Sites
• Delivery of Additional Educational Materials to Implementation Sites to refresh learning
• Practice Facilitation at Implementation Sites
• Delivery of Obesity SMA Intervention
• Qualitative and Survey Data Collection regarding- Patient and Provider Implementation Outcomes of acceptability, feasibility, appropriateness
• Quantitative Data Collection of Implementation Outcomes of adoption, fidelity, effectiveness, implementation cost
• Patient and Employee Advisory Panel Input into Implementation Evaluation

Aim 3: To monitor and evaluate the maintenance of the Obesity Treatment SMAs across all Northeast Ohio Primary Care Practices (Maintenance & Sustainment)

Maintenance & Sustainment Phase (15 months)

• Quantitative Data Collection of Implementation Outcomes- adoption, fidelity, effectiveness, cost- with comparison to active implementation phase
• Capture Practice Level adaptations with comparison to active implementation phase.

Study Population (Potential Eligible / Intended Reach) Potentially eligible patients: Utilizing electronic medical record data, the investigators determined across the 56 outpatient primary care practices, the total patient population ages 20-75 with a body mass index (BMI) >/= 30 who have had a primary care visit within the past 18 months is 170,087 patients.

Intended reach: The intended reach will exclude patients with a history of bariatric surgery, current pregnancy and post-partum within 180 days, current cancer diagnosis or cognitive impairment diagnosis. Exclusion criteria are based upon unique clinical situations affecting BMI as well as conditions that may affect SMA participation. Prior obesity SMA participation will not be an exclusion. The intended reach includes 141,735 potentially eligible patients ages 20 to 75, with an office visit within 18 months, BMI >/=30, with exclusion of history of bariatric surgery, pregnancy, current cancer diagnosis or cognitive impairment diagnosis. Through navigator support, the investigators will assess demographic distribution of patients with uptake of the program and will ensure representation from groups with higher Area Deprivation Index (ADI). If this is not the case, the investigators will conduct outreach to eligible patients outside of an office visit, through the MyChart portal or telephone outreach. Scripts will be created as part of routine clinical care during the pre-implementation phase.

Entry Into SMAs Entry into the obesity treatment program will be offered by a patient's primary care provider as part of usual clinical care and can be offered at the time of an office visit. In addition, the clinical and project teams will create flyers describing the program to be available to primary care practices. This information will also be available through our MyChart patient portal in the EPIC(6) electronic medical record. Scripts will be created as part of routine clinical care during the pre-implementation phase.

Once the referral to the program is made, the patient will complete an individual appointment, offered as both in-person or virtual, with either an obesity-trained primary care provider, an endocrinology provider, or a Wellness Medicine provider from the Primary Care Institute. This individual appointment will be focused on discussion of the diagnosis of obesity and treatment options, including the SMA program. If the patient accepts the referral to the SMA, the first appointment will be scheduled. The program will include options of scheduling both the initial individual appointment and the SMA through the primary care practice office or an opportunity for self-scheduling through our MyChart patient portal. Throughout the study, the investigators will have primary care navigator support to ensure outreach to underrepresented groups.

• Study Type: Observational
• Enrollment (Estimated): 3600

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	Change in body weight as measured in a percentage of total weight compared to baseline.	Baseline, every 6 months during intervention, and 6 months post-intervention
Outcome measure type: Reach	Actual reach measuring the overall total number of patients: Program participation (offered): total number of patients who are offered the program.; Program participation (enrolled): total number of patients who are enrolled in the program.; Program participation (completed): total number of patients who complete the program.	Timing and frequency of measurement is every 3 months.
Outcome measure type: Effectiveness	Hospitalizations and emergency department visits: number of acute care hospitalizations, number of emergency department visits. Determining association between obesity treatment and acute care utilization.	Hospitalizations and emergency department visits - every 6 months
Outcome measure type: Effectiveness	Body Composition (body impedance analysis machine): subset of patients electing to have measurement	Baseline and end of intervention
Patient Reported Outcomes- PROMIS10 Global Health Survey	PROMIS-10 Global Health (8) instrument routinely collected from Cleveland Clinic patients and utilized in Endocrinology SMAs as part of Obesity Survey to assess change in item scores over time.	Baseline, every month during the SMA intervention and 6 months post-intervention.
Provider Bias Related to Patients with Obesity survey	Fat Phobia Scale-14 Item Short Form survey to assess primary care providers change in bias item scores over time.	Administered at baseline and at end of intervention period.
Provider views of Acceptability, Appropriateness, Feasibility survey	Captured through surveys, provider views of Acceptability, Appropriateness, Feasibility (19). Providers views of intervention may impact adoption of intervention for patients. Measured by change in item scores over time.	Administered to primary care providers every 6 months starting baseline throughout active implementation & maintenance.
Outcome Measure: Adoption (Actual)	Number of primary care providers in each practice group referring to obesity SMA will be measured by number of referrals attributed to practice group.	Every 3 months during the intervention period
Outcome measure: SMA Leader Adoption	Number of obesity trained providers who are trained to lead SMAs who participate in program as SMA leader measured by number of SMAs attributed to eligible providers.	Every 3 months during intervention period.
Formal Qualitative Assessment of context of high referral and low referral practices: Pre-implementation	To understand barriers and facilitators to uptake of obesity treatment; Semi-structured interviews with non-patient (employee) key stakeholders at high/low referral sites; Direct field observations of high/low referral practice sites Qualitative methodologists will analyze the qualitative data (transcripts and descriptive fieldnotes) will be coded to reflect key domains of interest and emergent themes. Demographics of the qualitative sample will be reported in aggregate.	Pre-implementation
Formal Qualitative Assessment: Observations of Employee and Patient Advisory Panels	To examine anticipated barriers and facilitators to implementation and to assess ongoing implementation activities. Qualitative methodologists will analyze the qualitative data (fieldnotes) will be coded to reflect key domains of interest and emergent themes.	Quarterly meetings throughout pre- and active implementation.
Formal Qualitative Assessment: Semi-structured Interviews with Patients at High/Low Referral Sites	Inviting a sample of patients receiving the intervention at high and low referral sites to participate in interviews to assess perceptions of acceptability of and satisfaction with group visits for intensive lifestyle intervention for obesity. Qualitative methodologists will analyze the qualitative data (transcripts) will be coded to reflect key domains of interest and emergent themes. Demographics of the qualitative sample will be reported in aggregate.	Baseline, 6 months, 12 months during active implementation
Formal Qualitative Assessment: Periodic Reflections with Agents of Implementation	Periodic reflections conducted with a subgroup of pool of obesity trained providers and weight management navigators across practice locations to understand barriers and facilitators to uptake of obesity treatment. Qualitative methodologists will analyze the qualitative data (descriptive fieldnotes) will be coded to reflect key domains of interest and emergent themes.	Monthly or bimonthly throughout active implementation and maintenance.
Outcome measure type: Effectiveness	Outpatient visits: number of outpatient visits (in clinic or virtual, primary care and specialty). Determining association between obesity treatment and outpatient utilization.	Every 6 months
Outcome measure type: Effectiveness	Glycosylated Hemoglobin: change in A1c as measured in a percentage compared to baseline to assess effect of obesity treatment on glycemic control.	Baseline, every 6 months during intervention, and 6 months post-intervention
Outcome measure type: Effectiveness	Low Density Lipoprotein (LDL) Triglycerides measured in mg/dl compared to baseline to assess effect of obesity treatment on lipid control.	Baseline, every 6 months during intervention, and 6 months post-intervention
Outcome measure type: Effectiveness	Blood pressure as measured in mmHg to assess effect of obesity treatment on blood pressure control.	Baseline, every 6 months during intervention, and 6 months post-intervention
Patient Reported Outcomes - Obesity history, diabetes/hypoglycemia history if relevant, diet, exercise Survey	Surveys currently utilized in Department of Endocrinology SMAs to assess change in item scores over time.	Baseline, then follow-up survey every month during AMS intervention.
Outcome Measure: Adoption (Actual)	Number of primary care providers in each practice group referring to obesity SMA will be measured by the percentage of referrals attributed to practice group.	Every 3 months during intervention period
Outcome Measure: SMA Leader Adoption	Percentage of obesity trained providers who are trained to lead SMA who participate in program as an SMA leader will be measured by percentage of SMAs attributed to eligible providers.	Every 3 months during intervention period
Outcome measure type: Reach (Other)	(Other) reach - * Session attendance rate: proportion of sessions attended per person (average and distribution) measured by percentage of sessions completed.	At 18 months post intervention start time of Practice Group 1, then every 3 months until end of study.

Collaborators and Investigators

• Sponsor: Anita Misra-Hebert
• Collaborators: Patient-Centered Outcomes Research Institute; The Cleveland Clinic

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Shared Medical Appointment Obesity Care; Intensive Lifestyle Treatment for Obesity; ACTIVATE OC
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 24-1147; PCORI Funded (Other Identifier: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data used for this study will include human research participant data that are sensitive and cannot be publicly shared due to legal and ethical restrictions by the Cleveland Clinic regulatory bodies, including the institutional review board and legal counsel. We will make our data sets available on request, under appropriate data use agreements with the specific parties interested in academic collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No