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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity, Hyperlipidemias, Polycystic Ovary Syndrome, Hypertension, Coronary Heart Disease, Heart Failure, Depression, Anxiety, Type II Diabetes, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Lifestyle counseling and coaching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>participants that have received a referral, and opt-in for the adjunctive treatment plan | Behavioral: Lifestyle counseling and coaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demand | initial demand for the program | 1 month | 
| Attrition rate | Drop out rate after opting in to the intervention | 4 months | 
| physical activity | minutes of moderate to vigorous physical activity | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure (mmHg) | 4 Months | 
| Blood glucose | mg/dL | 4 Months | 
| blood lipids | triglycerides (mg/dL) | 4 Months | 
| Glycosylated hemoglobin | A1C (percent of hemoglobin that is glycosylated) | 4 Months | 
| BMI | weight and height will be combined to report BMI in kg/m^2 | 4 Months | 
| total cholesterol | Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol. | 4 Months | 
| Self-efficacy | 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. | 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle, chronic disease, physical activity