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:

  1. Understand variables that affect success in application of lifestyle medicine to lead to improved patient outcomes.
  2. Develop a model for practice evaluation that can be utilized for board certification of providers and practices that utilize lifestyle medicine.
  3. 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

  • United States
    • 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.
Behavioral: Lifestyle Medicine
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

Ohio University

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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