Personalized Health Planning--Shared Medical Appointments for Obesity

Sponsor
Methodist Health System (Other)
Overall Status
Completed
CT.gov ID
NCT05938933
Collaborator
(none)
11
1
1
23.2
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PHP
  • Behavioral: SMA
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Personalized Health Planning--Shared Medical Appointments for Obesity
Actual Study Start Date :
Feb 19, 2020
Actual Primary Completion Date :
Jan 25, 2022
Actual Study Completion Date :
Jan 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort

Cohort

Behavioral: PHP
personalized health planning (PHP)

Behavioral: SMA
shared medical appointments (SMAs)

Outcome Measures

Primary Outcome Measures

  1. Weight Improvement [within Seven Months]

    Weight will be measured to determine improvement and analyzed to report BMI

  2. Height measurement [within Seven Months]

    Height will be measured in inches to cucullate inches lost

  3. Effectiveness of the intervention [Seven months]

    weight and height will combined report BMI in pounds and inches to determine effectiveness of intervention

Secondary Outcome Measures

  1. Blood pressure [within seven months]

    will me measured to determine changes in systolic/diastolic blood pressure

  2. Waist circumference [within seven months]

    waist circumference will be measured in inches to determine inches difference

  3. Depression [within seven months]

    depression will be measured by observation over the duration of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Charlton Family Medicine Dallas Texas United States 75237

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Khadija Kabani, DO, Methodist Charlton Family Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT05938933
Other Study ID Numbers:
  • 066.FAM.2019.C
First Posted:
Jul 11, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Methodist Health System
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2023