Clinical trial NCT05938933: Personalized Health Planning--Shared Medical Appointments for Obesity
Official title: Personalized Health Planning--Shared Medical Appointments for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: personalized health planning
shared medical appointments
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obesity affects a large portion of our population and accounts for a significant individual health burden for both individual patients and society. Though as little as 3 to 5% weight loss is associated with significant clinical benefits,1,2 current approaches to treat patients with obesity are not providing patients with the interventions needed to routinely see this change. One potential solution to this problem is utilizing personalized health planning (PHP) shared medical appointments (SMAs) to address the treatment of obesity. As PHP SMA has shown to improve clinical outcomes and patient satisfaction when compared to traditional care in other chronic illnesses,3,4 it could also be useful as a strategy to improve the efficiency and effectiveness of treating patients with obesity.

Detailed description: There will be 14 total participants in this study. All will be current patients enrolled at the Methodist Charlton Family Medicine Clinic in Dallas, TX. Female and male patients will be selected based on individual provider recommendations within the Family Medicine Clinic at Methodist Charlton Medical Center (Dallas, TX).

Obesity affects a large portion of our population and accounts for a significant individual health burden for both individual patients and society. Though as little as 3 to 5% weight loss is associated with significant clinical benefits,1,2 current approaches to treat patients with obesity are not providing patients with the interventions needed to routinely see this change. One potential solution to this problem is utilizing personalized health planning (PHP) shared medical appointments (SMAs) to address the treatment of obesity. As PHP SMA has shown to improve clinical outcomes and patient satisfaction when compared to traditional care in other chronic illnesses,3,4 it could also be useful as a strategy to improve the efficiency and effectiveness of treating patients with obesity. PHP tailors health care to the needs, values, and preferences of the individual patient. It facilitates the use of the best available resources for proactive, predictive medicine while recognizing the value of engaging patients in their care. Its clinical workflow allows for creation of a personal health plan for each patient in which shared patient-provider goals are outlined to address the patient's proximate and long-term health goals and risks.

The PHP model is flexible and adaptable to many clinical needs and settings. In the program described here, PHP is adapted for use within a SMA for individuals with obesity. SMAs are conducted in 90-minute group visits, wherein 8 to 12 patients meet together with a small clinical team that always includes a provider.

Eligibility criteria: Inclusion Criteria:

* Current patients enrolled at the Methodist Charlton Family Medicine Clinic in Dallas, TX.
* Female and male patients will be selected based on individual provider recommendations within the Family Medicine Clinic at Methodist Charlton Medical Center (Dallas, TX)
* Patients will include motivated adults in our clinic from the ages of 30 to 60 yrs old with BMI ranges of 35 to 50 without significant mood or cardio-pulmonary issues.
* If a patient does have diabetes mellitus (DM), it needs to be under reasonable control (i.e., A1C less than 9).

Exclusion Criteria:

* uncontrolled depression with a Patient Health Questionnaire-9(PHQ-9) score greater than 9
* history of bariatric surgery or future plans for bariatric surgery
* wheelchair bound
* uncontrolled chronic obstructive pulmonary disease (COPD)/asthma or supplemental oxygen dependence
* uncontrolled congestive heart failure (CHF)
* uncontrolled DM with A1C greater than 9
* pregnancy
* active cancer

Primary outcomes:
measure: weight change
timeFrame: within Seven Months
Secondary outcomes:
measure: change in blood pressure
timeFrame: within seven months
measure: Change in waist circumferences
timeFrame: within seven months
measure: Depression
timeFrame: within seven months
measure: change in glycated hemoglobin percentage( A1C)
timeFrame: within seven months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Charlton Family Medicine
state: Texas
Study officials:
affiliation: Methodist Charlton Family Medicine
name: Khadija Kabani, DO
role: PRINCIPAL_INVESTIGATOR
References: