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ObesityNCT06049420

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

A study testing Lifestyle counseling and coaching in people with Obesity and Hyperlipidemias, run by West Virginia School of Osteopathic Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Lifestyle counseling and coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteUnited States
Study dates
1 Feb 2025to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christopher L Pankey, Ph.D. contact

3047936576

cpankey@osteo.wvsom.edu

United States1 site, 1 recruiting
  • West Virginia School of Osteopathic Medicine

    Lewisburg, West Virginia, 24901

    Dovenia Ponnoth, Ph.D., 3046476297, dponnoth@osteo.wvsom.edu

    Peter Feltman, 3046476284, pfeltman@osteo.wvsom.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Lifestyle counseling and coaching
Keywords
lifestyle, chronic disease, physical activity
Medical subject headings
Obesity, Hyperlipidemias, Polycystic Ovary Syndrome, Hypertension, Coronary Disease, Heart Failure, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle counseling and coachingBehavioural

    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.

Study groups in NCT06049420
Study groupRoleWhat they receive
ActiveExperimentalparticipants that have received a referral, and opt-in for the adjunctive treatment plan
Receives: Behavioral: Lifestyle counseling and coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demand

    initial demand for the program

    Measured: 1 month

  2. Attrition rate

    Drop out rate after opting in to the intervention

    Measured: 4 months

  3. physical activity

    minutes of moderate to vigorous physical activity

    Measured: 4 months

  4. Body Composition

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

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

  5. Body Composition

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

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

  6. Body Composition

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

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

Secondary outcomes (8)
  1. Blood pressure

    Systolic and diastolic blood pressure (mmHg)

    Measured: 4 Months

  2. Blood glucose

    mg/dL

    Measured: 4 Months

  3. blood lipids

    triglycerides (mg/dL)

    Measured: 4 Months

  4. Glycosylated hemoglobin

    A1C (percent of hemoglobin that is glycosylated)

    Measured: 4 Months

  5. BMI

    weight and height will be combined to report BMI in kg/m^2

    Measured: 4 Months

  6. total cholesterol

    Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol.

    Measured: 4 Months

  7. 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.

    Measured: 4 Months

  8. Basal Metabolic Rate

    Metabolic rate will be estimated via indirect calorimetry using a respiratory gas analyzer

    Measured: Recordings will occur once at enrollment, and once at the end of the intervention 4 weeks later.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start1 Feb 2025
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06049420
Sponsor's protocol ID
R010422CP
Status last verified
Jul 2025
First submitted
12 Sep 2023
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25764298
  • 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.

    PubMed 26238869

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle counseling and coaching in people with Obesity and Hyperlipidemias, run by West Virginia School of Osteopathic Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christopher L Pankey, Ph.D. (3047936576, cpankey@osteo.wvsom.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demand (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06049420, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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