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临床试验/NCT05938933
NCT05938933已完成不适用

Personalized Health Planning--Shared Medical Appointments for Obesity

Methodist Health System1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
weight change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

weight change

时间窗: 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.

次要结局

  • Change in waist circumferences(within seven months)
  • change in blood pressure(within seven months)
  • Depression(within seven months)
  • change in glycated hemoglobin percentage( A1C)(within seven months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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