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
|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|
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 , 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|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)|
|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|
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.
- Demand [ Time Frame: 1 month ]initial demand for the program
- Attrition rate [ Time Frame: 4 months ]Drop out rate after opting in to the intervention
- physical activity [ Time Frame: 4 months ]minutes of moderate to vigorous physical activity
- Blood pressure [ Time Frame: 4 Months ]Systolic and diastolic blood pressure (mmHg)
- Blood glucose [ Time Frame: 4 Months ]mg/dL
- blood lipids [ Time Frame: 4 Months ]triglycerides (mg/dL)
- Glycosylated hemoglobin [ Time Frame: 4 Months ]A1C (percent of hemoglobin that is glycosylated)
- BMI [ Time Frame: 4 Months ]weight and height will be combined to report BMI in kg/m^2
- total cholesterol [ Time Frame: 4 Months ]Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol.
- 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.
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
|Contact: Christopher L Pankey, Ph.D.||email@example.com|
|Principal Investigator:||Christopher L Pankey, Ph.D.||West Virginia School of Osteopathic Medicine|