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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorWest Virginia School of Osteopathic Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Lifestyle counseling and coaching

    Behavioral

    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.

Treatment groups

95 Participants
are divided into 1 treatment group
Group A: ActiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Demand

initial demand for the program

Time frame
1 month
2

Attrition rate

Drop out rate after opting in to the intervention

Time frame
4 months
3

physical activity

minutes of moderate to vigorous physical activity

Time frame
4 months
4

Body Composition

Fat mass (kg) and Fat free mass (kg) will be collected pre- and post-intervention

Time frame
Once at enrollment, and once at cessation of the intervention 4 weeks later.

Secondary outcomes

1

Blood pressure

Systolic and diastolic blood pressure (mmHg)

Time frame
4 Months
2

Blood glucose

mg/dL

Time frame
4 Months
3

blood lipids

triglycerides (mg/dL)

Time frame
4 Months
4

Glycosylated hemoglobin

A1C (percent of hemoglobin that is glycosylated)

Time frame
4 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.