Personalized Health Planning--Shared Medical Appointments for Obesity

Obesity Clinical Trial

Official title:

Personalized Health Planning--Shared Medical Appointments for Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05938933
• Other study ID #: 066.FAM.2019.C
• Status: Completed
• Phase: N/A
• Start date: February 19, 2020
• Est. completion date: January 25, 2022

Study information

• Verified date: November 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• PHP
personalized health planning (PHP)
• SMA
shared medical appointments (SMAs)

Locations

Country	Name	City	State
United States	Methodist Charlton Family Medicine	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight change	tracked over the duration of the study for each participant and the effectiveness of the intervention will be determined by reductions in patients' post-intervention weight and percent weight loss.	within Seven Months
Secondary	change in blood pressure	Blood pressure measures over the duration of the study	within seven months
Secondary	Change in waist circumferences	Measurement of waist circumferences over the period of study	within seven months
Secondary	Depression	depression will be measured by observation over the duration of the study	within seven months
Secondary	change in glycated hemoglobin percentage( A1C)	Different measures for A1C over the	within seven months