- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03739034
Evaluation of a Lifestyle Medicine Practice
March 9, 2022 updated by: David Drozek, Ohio University
This project will evaluate the success of the PI's lifestyle medicine practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Athens, Ohio, United States, 45701
- Ohio University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle Medicine
Patients presenting for lifestyle medicine treatment to prevent, arrest or reverse chronic lifestyle related diseases.
|
Treatment modalities consist of encouraging a plant based, whole food diet, physical activity, stress management, healthy sleep, control of unhealthy habits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diastolic Blood Pressure
Time Frame: 1 year
|
change in diastolic blood pressure
|
1 year
|
Weight
Time Frame: 1 year
|
change in weight
|
1 year
|
Systolic Blood Pressure
Time Frame: 1 year
|
change in systolic blood pressure
|
1 year
|
Glycosylated hemoglobin
Time Frame: 1 year
|
change in glycosylated hemoglobin
|
1 year
|
Total cholesterol
Time Frame: 1 year
|
change in total cholesterol
|
1 year
|
low density lipoprotein cholesterol
Time Frame: 1 year
|
change in low density lipoprotein cholesterol
|
1 year
|
triglycerides
Time Frame: 1 year
|
change in triglycerides
|
1 year
|
high density lipoprotein cholesterol
Time Frame: 1 year
|
change in high density lipoprotein cholesterol
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
steps
Time Frame: 1 year
|
average number of steps per day
|
1 year
|
exercise
Time Frame: 1 year
|
average minutes of exercise per day
|
1 year
|
fiber
Time Frame: 1 year
|
average grams of fiber consumed on a daily basis
|
1 year
|
legumes
Time Frame: 1 year
|
average quantity of legumes consumed on a daily basis
|
1 year
|
full plate
Time Frame: 1 year
|
average percent of plate filled with foods high in fiber and water
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2018
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
March 1, 2022
Study Registration Dates
First Submitted
November 8, 2018
First Submitted That Met QC Criteria
November 8, 2018
First Posted (Actual)
November 13, 2018
Study Record Updates
Last Update Posted (Actual)
March 10, 2022
Last Update Submitted That Met QC Criteria
March 9, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-X-220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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