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Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients

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ClinicalTrials.gov Identifier: NCT06049420
Recruitment Status : Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
Christopher Pankey, West Virginia School of Osteopathic Medicine

Brief Summary:
Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings.

Condition or disease Intervention/treatment Phase
Obesity Hyperlipidemias Polycystic Ovary Syndrome Hypertension Coronary Heart Disease Heart Failure Depression, Anxiety Type II Diabetes Metabolic Syndrome Behavioral: Lifestyle counseling and coaching Not Applicable

Detailed Description:

Patients will have the option to opt-in to this program if they receive a referral from their primary care physician at the Robert C. Byrd Clinic (RCBC). The referral period will be one month long, followed by 3 months of wellness facility access (intervention period). This pilot program will be restricted to adults (18-64 years old) with two or more diagnosed chronic diseases. Program admittance will be restricted to patients with diseases that have sufficient evidence for the efficacy of exercise therapy. As patients will be referred to the program, they will all have physician consent to participate in supervised physical activity. Standard care will proceed as determined by the primary care physician, as this program will be adjunctive treatment. As patient recruitment is contingent on physician referrals, the investigators have established a strong network with the family care physicians and administration from RCBC, and they are very confident that this program will be in high demand. Physicians will be reminded of the recruitment time 1-2 times/month for the 3 months preceding the start date by email, personal communication, and lunch seminars. Prior to accessing the wellness facility, each patient will be scheduled for an intake meeting. This intake meeting will be used to collect patient information (such as vital signs, morphometrics, demographics, physical activity history and readiness, health history, etc.), and understand patient goals (weight loss, glucose management, pain relief, blood pressure management, etc.). A patient questionnaire will be developed for this meeting, and patients will also fill out a physical activity readiness questionnaire. Motivational interviewing techniques will be implemented to promote adherence to the program. Individualized goals will be determined and recorded. Patient preferences such as individual training/coaching vs. group fitness will also be determined. Following the intake meeting, each patient will be advised on how they may best reach their goals, and support will be provided by the PI or a trained medical student for implementation of physical activity. The wellness facility (Greenbrier Valley Fitness) was specifically chosen as it offers a wide variety of exercise equipment and activities including strength training, cross training, group fitness, yoga, and many others. The PI or student research technicians will be present for questions, coaching, and monitoring at all times when the patient is being active. Each patient will be provided with personalized exercise therapy that is best suited for their personal goals and disease states.

An overarching goal is for each patient to achieve 150 minutes per week of moderate to vigorous physical activity. This benchmark was chosen as it is the current recommendation from the CDC [1], and has been demonstrated to be therapeutic for all, and curative for some, of the chronic diseases mentioned above [2,3]. Importantly, some patients may not make this goal within the allotted time-frame depending on their current fitness and disease states. In order to assess adherence and attrition, the investigators will have to assess individuals based on their individualized goals. Any participant that fails to attend >50% of their scheduled activities, or fails to show up at least once in the last 15 days of the study will count as drop-outs.

Data collected on patients will only occur after their referral to our program, so that no patient data will be shared between institutions (WVSOM and the Robert C. Byrd Clinic) and so that the investigators can properly deliver informed consent to patients that are willing to have their data used for research purposes. GraphPad Prism and excel software will be used to store and analyze the data, using the descriptive statistics and computational functions to provide count data and attrition rates. Additional analyses of factors such as disease prevalence, demographics, age, gender, and appropriate interactions may also be assessed contingent on the study population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be able to opt-in to the protocol for adjunctive treatment, and their outcome measures will be assessed relative to similar patients that do not opt-in to the intervention (standard care).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025


Arm Intervention/treatment
Experimental: Active
participants that have received a referral, and opt-in for the adjunctive treatment plan
Behavioral: Lifestyle counseling and coaching
Each participant will be provided with personalized exercise therapy that is best suited for their personal goals and disease states. Participants in this study will be encouraged to establish accountability through setting SMART goals, and through monitoring their activity using wearable fitness technology provided to them. This program will also aim to create a sense of community as group activity classes will be available for those that wish to attend. Individualized exercise/physical activity prescriptions will be provided and discussed.




Primary Outcome Measures :
  1. Demand [ Time Frame: 1 month ]
    initial demand for the program

  2. Attrition rate [ Time Frame: 4 months ]
    Drop out rate after opting in to the intervention

  3. physical activity [ Time Frame: 4 months ]
    minutes of moderate to vigorous physical activity


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 4 Months ]
    Systolic and diastolic blood pressure (mmHg)

  2. Blood glucose [ Time Frame: 4 Months ]
    mg/dL

  3. blood lipids [ Time Frame: 4 Months ]
    triglycerides (mg/dL)

  4. Glycosylated hemoglobin [ Time Frame: 4 Months ]
    A1C (percent of hemoglobin that is glycosylated)

  5. BMI [ Time Frame: 4 Months ]
    weight and height will be combined to report BMI in kg/m^2

  6. total cholesterol [ Time Frame: 4 Months ]
    Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol.

  7. Self-efficacy [ Time Frame: 4 Months ]

    Exercise Self Efficacy scale - ranges from 0 (low self efficacy) to 10 (high self efficacy)

    These data measure individual's confidence in his or her capacity to execute behaviors necessary to maintain an active lifestyle.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Program admittance will be restricted to patients with 2+ diagnosed diseases that have sufficient evidence for the efficacy of exercise therapy (obesity, hyperlipidemia, metabolic syndrome, polycystic ovarian syndrome, type II diabetes, hypertension, coronary heart disease, heart failure, depression, anxiety)
  • physician referral required

Exclusion Criteria:

  • no chronic disease diagnosis, lack of physician referral, unwillingness to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049420


Contacts
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Contact: Christopher L Pankey, Ph.D. 3047936576 cpankey@osteo.wvsom.edu

Locations
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United States, West Virginia
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, United States, 24901
Contact: Dovenia Ponnoth, Ph.D.    304-647-6297    dponnoth@osteo.wvsom.edu   
Contact: Peter Feltman    3046476284    pfeltman@osteo.wvsom.edu   
Sponsors and Collaborators
West Virginia School of Osteopathic Medicine
Investigators
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Principal Investigator: Christopher L Pankey, Ph.D. West Virginia School of Osteopathic Medicine
Additional Information:
Publications:
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Responsible Party: Christopher Pankey, Associate Professor, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT06049420    
Other Study ID Numbers: R010422CP
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: October 19, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Pankey, West Virginia School of Osteopathic Medicine:
lifestyle
chronic disease
physical activity
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Coronary Disease
Metabolic Syndrome
Hyperlipidemias
Syndrome
Chronic Disease
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Gonadal Disorders
Endocrine System Diseases
Myocardial Ischemia
Disease Attributes
Dyslipidemias