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.
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
- Conditions the study is for
- Obesity, Hyperlipidemias, Polycystic Ovary Syndrome
- What is being tested?
- Lifestyle counseling and coaching
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Obesity, Hyperlipidemias, Polycystic Ovary Syndrome, Hypertension, Coronary Heart Disease, Heart Failure
- 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 group | Role | What they receive |
|---|---|---|
| Active | Experimental | participants 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.
Demand
initial demand for the program
Measured: 1 month
Attrition rate
Drop out rate after opting in to the intervention
Measured: 4 months
physical activity
minutes of moderate to vigorous physical activity
Measured: 4 months
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.
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.
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)
Blood pressure
Systolic and diastolic blood pressure (mmHg)
Measured: 4 Months
Blood glucose
mg/dL
Measured: 4 Months
blood lipids
triglycerides (mg/dL)
Measured: 4 Months
Glycosylated hemoglobin
A1C (percent of hemoglobin that is glycosylated)
Measured: 4 Months
BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 4 Months
total cholesterol
Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol.
Measured: 4 Months
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
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.
- First posted22 Sep 2023
- Study start1 Feb 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- West Virginia School of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pankey, West Virginia School of Osteopathic Medicine
- Investigators
- Christopher L Pankey, Ph.D., Principal investigator, West Virginia School of Osteopathic Medicine
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 25764298Hupin 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients
- ClinicalTrials.gov ID
- NCT06049420
- Acronym / sponsor ID
- R010422CP
- Conditions
- Obesity, Hyperlipidemias, Polycystic Ovary Syndrome, Hypertension, Coronary Heart Disease, Heart Failure
- Keywords
- lifestyle, chronic disease, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- West Virginia School of Osteopathic MedicineUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Lifestyle counseling and coachingparticipants that have received a referral, and opt-in for the adjunctive treatment plan |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- no chronic disease diagnosis, lack of physician referral, unwillingness to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counseling and coachingEach 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. | Behavioural | Active |
Primary outcome
Demand
Time frame: 1 month
initial demand for the program
Attrition rate
Time frame: 4 months
Drop out rate after opting in to the intervention
physical activity
Time frame: 4 months
minutes of moderate to vigorous physical activity
Body Composition
Time frame: Once at enrollment, and once at cessation of the intervention 4 weeks later.
Fat mass (kg) and Fat free mass (kg) will be collected pre- and post-intervention
Body Composition
Time frame: Once at enrollment, and once at cessation of the intervention 4 weeks later.
bone mineral content (g) will be collected pre- and post-intervention
Body Composition
Time frame: Once at enrollment, and once at cessation of the intervention 4 weeks later.
bone density (g/cm^2)) will be collected pre- and post-intervention
8 secondary outcomes
Blood pressure
Time frame: 4 Months
Blood glucose
Time frame: 4 Months
blood lipids
Time frame: 4 Months
Glycosylated hemoglobin
Time frame: 4 Months
BMI
Time frame: 4 Months
total cholesterol
Time frame: 4 Months
Self-efficacy
Time frame: 4 Months
Basal Metabolic Rate
Time frame: Recordings will occur once at enrollment, and once at the end of the intervention 4 weeks later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 25764298Palakodeti 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.
- Background: PubMed 26238869Hupin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher L Pankey, Ph.D. principal investigator
West Virginia School of Osteopathic Medicine
1 site in 1 country: see every site and its status.
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.