Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients
Primary Purpose
Obesity, Hyperlipidemias, Polycystic Ovary Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling and coaching
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring lifestyle, chronic disease, physical activity
Eligibility 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.
Sites / Locations
- West Virginia School of Osteopathic Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
participants that have received a referral, and opt-in for the adjunctive treatment plan
Outcomes
Primary Outcome Measures
Demand
initial demand for the program
Attrition rate
Drop out rate after opting in to the intervention
physical activity
minutes of moderate to vigorous physical activity
Secondary Outcome Measures
Blood pressure
Systolic and diastolic blood pressure (mmHg)
Blood glucose
mg/dL
blood lipids
triglycerides (mg/dL)
Glycosylated hemoglobin
A1C (percent of hemoglobin that is glycosylated)
BMI
weight and height will be combined to report BMI in kg/m^2
total cholesterol
Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol.
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.
Full Information
NCT ID
NCT06049420
First Posted
September 12, 2023
Last Updated
October 17, 2023
Sponsor
West Virginia School of Osteopathic Medicine
1. Study Identification
Unique Protocol Identification Number
NCT06049420
Brief Title
Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients
Official Title
Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2024 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia School of Osteopathic Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hyperlipidemias, Polycystic Ovary Syndrome, Hypertension, Coronary Heart Disease, Heart Failure, Depression, Anxiety, Type II Diabetes, Metabolic Syndrome
Keywords
lifestyle, chronic disease, physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
participants that have received a referral, and opt-in for the adjunctive treatment plan
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling and coaching
Intervention Description
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 Measure Information:
Title
Demand
Description
initial demand for the program
Time Frame
1 month
Title
Attrition rate
Description
Drop out rate after opting in to the intervention
Time Frame
4 months
Title
physical activity
Description
minutes of moderate to vigorous physical activity
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Systolic and diastolic blood pressure (mmHg)
Time Frame
4 Months
Title
Blood glucose
Description
mg/dL
Time Frame
4 Months
Title
blood lipids
Description
triglycerides (mg/dL)
Time Frame
4 Months
Title
Glycosylated hemoglobin
Description
A1C (percent of hemoglobin that is glycosylated)
Time Frame
4 Months
Title
BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
4 Months
Title
total cholesterol
Description
Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol.
Time Frame
4 Months
Title
Self-efficacy
Description
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.
Time Frame
4 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher L Pankey, Ph.D.
Phone
3047936576
Email
cpankey@osteo.wvsom.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher L Pankey, Ph.D.
Organizational Affiliation
West Virginia School of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia School of Osteopathic Medicine
City
Lewisburg
State/Province
West Virginia
ZIP/Postal Code
24901
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dovenia Ponnoth, Ph.D.
Phone
304-647-6297
Email
dponnoth@osteo.wvsom.edu
First Name & Middle Initial & Last Name & Degree
Peter Feltman
Phone
3046476284
Email
pfeltman@osteo.wvsom.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25764298
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.
Results Reference
background
PubMed Identifier
26238869
Citation
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.
Results Reference
background
Links:
URL
https://www.cdc.gov/physicalactivity/index.html
Description
[1] CDC. Physical Activity. Centers for Disease Control and Prevention. Published July 25, 2022. Accessed October 7, 2022.
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Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients
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