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

NCT06049420 | Recruiting

• 1 other identifier: R010422CP
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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; Heart Failure; Depression, Anxiety; Type II Diabetes; Metabolic Syndrome

Keywords

lifestyle; chronic disease; physical activity

Outcome Measures

Primary Outcomes (6)

• Demand

  initial demand for the program

  1 month

• Attrition rate

  Drop out rate after opting in to the intervention

  4 months

• physical activity

  minutes of moderate to vigorous physical activity

  4 months

• Body Composition

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

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

• Body Composition

  bone mineral content (g) will be collected pre- and post-intervention

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

• Body Composition

  bone density (g/cm\^2)) will be collected pre- and post-intervention

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

Secondary Outcomes (8)

• Blood pressure

  4 Months

• Blood glucose

  4 Months

• blood lipids

  4 Months

• Glycosylated hemoglobin

  4 Months

• BMI

  4 Months

Study Arms (1)

Active

EXPERIMENTAL

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

Behavioral: Lifestyle counseling and coaching

Interventions

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.

Active

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• West Virginia School of Osteopathic Medicine: lead

Study Sites (1)

West Virginia School of Osteopathic Medicine

Lewisburg, West Virginia, 24901, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 25764298 BACKGROUND

• 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.

  PMID: 26238869 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Obesity; Hyperlipidemias; Polycystic Ovary Syndrome; Hypertension; Coronary Disease; Heart Failure; Depression; Anxiety Disorders; Diabetes Mellitus, Type 2; Metabolic Syndrome; Chronic Disease; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Disease Attributes; Pathologic Processes

Study Officials

• Christopher L Pankey, Ph.D.

  West Virginia School of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher L Pankey, Ph.D.

CONTACT

3047936576; cpankey@osteo.wvsom.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 22, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)