Recruiting

Lifestyle Medicine

Sponsor:

West Virginia School of Osteopathic Medicine

Code:

NCT06049420

Conditions

Obesity

Hyperlipidemias

Polycystic Ovary Syndrome

Hypertension

Coronary Heart Disease

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Lifestyle counseling and coaching

Study Details

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.

Conditions

Obesity

Hyperlipidemias

Polycystic Ovary Syndrome

Hypertension

Coronary Heart Disease

Study ID

NCT06049420

Start date

Feb 1, 2025

Status verified date

Jul, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

95 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active

participants that have received a referral, and opt-in for the adjunctive treatment plan

Interventions

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.

Primary outcome measure

  • Demand [ Time Frame: 1 month ]
  • Attrition rate [ Time Frame: 4 months ]
  • physical activity [ Time Frame: 4 months ]
  • Body Composition [ Time Frame: Once at enrollment, and once at cessation of the intervention 4 weeks later. ]
  • Body Composition [ Time Frame: Once at enrollment, and once at cessation of the intervention 4 weeks later. ]
  • Body Composition [ Time Frame: Once at enrollment, and once at cessation of the intervention 4 weeks later. ]

Central Contacts and Locations

Central contacts

Christopher L Pankey, Ph.D.

3047936576cpankey@osteo.wvsom.edu

Locations

West Virginia School of Osteopathic Medicine

Recruiting

Lewisburg, West Virginia, United States, 24901

Contacts

More Information

Sponsor

West Virginia School of Osteopathic Medicine

Last update posted

Jul 25, 2025

Last verified

Jul, 2025

Keywords

  • lifestyle
  • chronic disease
  • physical activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia School of Osteopathic Medicine on 2025-07-25.