Chronic Lifestyle Related DiseaseNCT03739034
Evaluation of a Lifestyle Medicine Practice
A study testing Lifestyle Medicine in people with Chronic Lifestyle Related Disease and Diabetes, run by Ohio University at 1 site in United States.
Trial summary
This project will evaluate the success of the PI's lifestyle medicine practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Lifestyle Related Disease, Diabetes, Overweight and Obesity
- What is being tested?
- Lifestyle Medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This project will evaluate the success of the PI's lifestyle medicine practice.
Read the detailed description
The main objective of the study is to evaluate the effectiveness of the PI's lifestyle medicine practice over time.
Sub-objectives are:
- Understand variables that affect success in application of lifestyle medicine to lead to improved patient outcomes.
- Develop a model for practice evaluation that can be utilized for board certification of providers and practices that utilize lifestyle medicine.
- Evaluate the reimbursement success of lifestyle medicine services as a factor of billing codes and insurance providers.
- Conditions
- Chronic Lifestyle Related Disease, Diabetes, Overweight and Obesity, Dyslipidemias, Hypertension, Cardiovascular Diseases
- Being tested
- Lifestyle Medicine
- Medical subject headings
- Diabetes Mellitus, Overweight, Obesity, Dyslipidemias, Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle MedicineBehavioural
Treatment modalities consist of encouraging a plant based, whole food diet, physical activity, stress management, healthy sleep, control of unhealthy habits.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Medicine | Experimental | Patients presenting for lifestyle medicine treatment to prevent, arrest or reverse chronic lifestyle related diseases. Receives: Behavioral: Lifestyle Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
change in weight
Measured: 1 year
Systolic Blood Pressure
change in systolic blood pressure
Measured: 1 year
Diastolic Blood Pressure
change in diastolic blood pressure
Measured: 1 year
Glycosylated hemoglobin
change in glycosylated hemoglobin
Measured: 1 year
Total cholesterol
change in total cholesterol
Measured: 1 year
low density lipoprotein cholesterol
change in low density lipoprotein cholesterol
Measured: 1 year
triglycerides
change in triglycerides
Measured: 1 year
high density lipoprotein cholesterol
change in high density lipoprotein cholesterol
Measured: 1 year
Secondary outcomes (5)
steps
average number of steps per day
Measured: 1 year
exercise
average minutes of exercise per day
Measured: 1 year
fiber
average grams of fiber consumed on a daily basis
Measured: 1 year
legumes
average quantity of legumes consumed on a daily basis
Measured: 1 year
full plate
average percent of plate filled with foods high in fiber and water
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start28 Jun 2018
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lifestyle Related DiseaseStudies 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
- Patients are being treated with established lifestyle medicine modalities, tailored to the individual patient need and situation.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Drozek, Ohio University
- Investigators
- David S Drozek, DO, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739034
- Sponsor's protocol ID
- 18-X-220
- Status last verified
- Mar 2022
- First submitted
- 8 Nov 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Lifestyle Medicine Practice
- ClinicalTrials.gov ID
- NCT03739034
- Acronym / sponsor ID
- 18-X-220
- Conditions
- Chronic Lifestyle Related Disease, Diabetes, Overweight and Obesity, Dyslipidemias, Hypertension, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 13 Nov 2018 (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.
This project will evaluate the success of the PI's lifestyle medicine practice.
Detailed description
The main objective of the study is to evaluate the effectiveness of the PI's lifestyle medicine practice over time.
Sub-objectives are:
- Understand variables that affect success in application of lifestyle medicine to lead to improved patient outcomes.
- Develop a model for practice evaluation that can be utilized for board certification of providers and practices that utilize lifestyle medicine.
- Evaluate the reimbursement success of lifestyle medicine services as a factor of billing codes and insurance providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are being treated with established lifestyle medicine modalities, tailored to the individual patient need and situation.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Medicine | Experimental | Behavioral: Lifestyle MedicinePatients presenting for lifestyle medicine treatment to prevent, arrest or reverse chronic lifestyle related diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
Key exclusion criteria (1 listed)
- none
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 MedicineTreatment modalities consist of encouraging a plant based, whole food diet, physical activity, stress management, healthy sleep, control of unhealthy habits. | Behavioural | Lifestyle Medicine |
Primary outcome
Weight
Time frame: 1 year
change in weight
Systolic Blood Pressure
Time frame: 1 year
change in systolic blood pressure
Diastolic Blood Pressure
Time frame: 1 year
change in diastolic blood pressure
Glycosylated hemoglobin
Time frame: 1 year
change in glycosylated hemoglobin
Total cholesterol
Time frame: 1 year
change in total cholesterol
low density lipoprotein cholesterol
Time frame: 1 year
change in low density lipoprotein cholesterol
triglycerides
Time frame: 1 year
change in triglycerides
high density lipoprotein cholesterol
Time frame: 1 year
change in high density lipoprotein cholesterol
5 secondary outcomes
steps
Time frame: 1 year
exercise
Time frame: 1 year
fiber
Time frame: 1 year
legumes
Time frame: 1 year
full plate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- 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. This study is not recruiting at the moment.
David S Drozek, DO principal investigator
Ohio University
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 Medicine in people with Chronic Lifestyle Related Disease and Diabetes, run by Ohio University 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 1 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: finished, as of the sponsor's last update on 10 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2022.