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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06049420
• Other study ID #: R010422CP
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: West Virginia School of Osteopathic Medicine
• Contact: Christopher L Pankey, Ph.D.
• Phone: 3047936576
• Email: cpankey[@]osteo.wvsom.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 95
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	West Virginia School of Osteopathic Medicine	Lewisburg	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia School of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hupin D, Roche F, Gremeaux V, Chatard JC, Oriol M, Gaspoz JM, Barthelemy JC, Edouard P. Even a low-dose of moderate-to-vigorous physical activity reduces mortality by 22% in adults aged >/=60 years: a systematic review and meta-analysis. Br J Sports Med. 2015 Oct;49(19):1262-7. doi: 10.1136/bjsports-2014-094306. Epub 2015 Aug 3. — View Citation

Palakodeti S, Uratsu CS, Schmittdiel JA, Grant RW. Changes in physical activity among adults with diabetes: a longitudinal cohort study of inactive patients with Type 2 diabetes who become physically active. Diabet Med. 2015 Aug;32(8):1051-7. doi: 10.1111/dme.12748. Epub 2015 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demand	initial demand for the program	1 month
Primary	Attrition rate	Drop out rate after opting in to the intervention	4 months
Primary	physical activity	minutes of moderate to vigorous physical activity	4 months
Secondary	Blood pressure	Systolic and diastolic blood pressure (mmHg)	4 Months
Secondary	Blood glucose	mg/dL	4 Months
Secondary	blood lipids	triglycerides (mg/dL)	4 Months
Secondary	Glycosylated hemoglobin	A1C (percent of hemoglobin that is glycosylated)	4 Months
Secondary	BMI	weight and height will be combined to report BMI in kg/m^2	4 Months
Secondary	total cholesterol	Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol.	4 Months
Secondary	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

External Links

•   [1] CDC. Physical Activity. Centers for Disease Control and Prevention. Published July 25, 2022. Accessed October 7, 2022.