- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05938933
Personalized Health Planning--Shared Medical Appointments for Obesity
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75237
- Methodist Charlton Family Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort
|
personalized health planning (PHP)
shared medical appointments (SMAs)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight change
Time Frame: within Seven Months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: within seven months
|
depression will be measured by observation over the duration of the study
|
within seven months
|
|
change in blood pressure
Time Frame: within seven months
|
Blood pressure measures over the duration of the study
|
within seven months
|
|
Change in waist circumferences
Time Frame: within seven months
|
Measurement of waist circumferences over the period of study
|
within seven months
|
|
change in glycated hemoglobin percentage( A1C)
Time Frame: within seven months
|
Different measures for A1C over the
|
within seven months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Khadija Kabani, DO, Methodist Charlton Family Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 066.FAM.2019.C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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