Back to resultsEvaluation of a Lifestyle Medicine Practice
Primary Purpose
Chronic Lifestyle Related Disease, Diabetes, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Medicine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lifestyle Related Disease
Eligibility Criteria
Inclusion Criteria:
- Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
Exclusion Criteria:
- none
Sites / Locations
- Ohio University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle Medicine
Arm Description
Patients presenting for lifestyle medicine treatment to prevent, arrest or reverse chronic lifestyle related diseases.
Outcomes
Primary Outcome Measures
Weight
change in weight
Systolic Blood Pressure
change in systolic blood pressure
Diastolic Blood Pressure
change in diastolic blood pressure
Glycosylated hemoglobin
change in glycosylated hemoglobin
Total cholesterol
change in total cholesterol
low density lipoprotein cholesterol
change in low density lipoprotein cholesterol
triglycerides
change in triglycerides
high density lipoprotein cholesterol
change in high density lipoprotein cholesterol
Secondary Outcome Measures
steps
average number of steps per day
exercise
average minutes of exercise per day
fiber
average grams of fiber consumed on a daily basis
legumes
average quantity of legumes consumed on a daily basis
full plate
average percent of plate filled with foods high in fiber and water
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03739034
Brief Title
Evaluation of a Lifestyle Medicine Practice
Official Title
Evaluation of a Lifestyle Medicine Practice
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lifestyle Related Disease, Diabetes, Overweight and Obesity, Dyslipidemias, Hypertension, Cardiovascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients are being treated with established lifestyle medicine modalities, tailored to the individual patient need and situation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Medicine
Arm Type
Experimental
Arm Description
Patients presenting for lifestyle medicine treatment to prevent, arrest or reverse chronic lifestyle related diseases.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Medicine
Intervention Description
Treatment modalities consist of encouraging a plant based, whole food diet, physical activity, stress management, healthy sleep, control of unhealthy habits.
Primary Outcome Measure Information:
Title
Weight
Description
change in weight
Time Frame
1 year
Title
Systolic Blood Pressure
Description
change in systolic blood pressure
Time Frame
1 year
Title
Diastolic Blood Pressure
Description
change in diastolic blood pressure
Time Frame
1 year
Title
Glycosylated hemoglobin
Description
change in glycosylated hemoglobin
Time Frame
1 year
Title
Total cholesterol
Description
change in total cholesterol
Time Frame
1 year
Title
low density lipoprotein cholesterol
Description
change in low density lipoprotein cholesterol
Time Frame
1 year
Title
triglycerides
Description
change in triglycerides
Time Frame
1 year
Title
high density lipoprotein cholesterol
Description
change in high density lipoprotein cholesterol
Time Frame
1 year
Secondary Outcome Measure Information:
Title
steps
Description
average number of steps per day
Time Frame
1 year
Title
exercise
Description
average minutes of exercise per day
Time Frame
1 year
Title
fiber
Description
average grams of fiber consumed on a daily basis
Time Frame
1 year
Title
legumes
Description
average quantity of legumes consumed on a daily basis
Time Frame
1 year
Title
full plate
Description
average percent of plate filled with foods high in fiber and water
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Drozek, DO
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Lifestyle Medicine Practice
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