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NCT03739034 Clinical Trial

Evaluation of a Lifestyle Medicine Practice

Hypertension Clinical Trial

Official title:
Evaluation of a Lifestyle Medicine Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03739034
Other study ID # 18-X-220
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 28, 2018
Est. completion date March 1, 2022

Study information
Verified date March 2022
Source Ohio University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project will evaluate the success of the PI's lifestyle medicine practice.

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.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care. Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lifestyle Medicine
Treatment modalities consist of encouraging a plant based, whole food diet, physical activity, stress management, healthy sleep, control of unhealthy habits.

Locations
Country Name City State
United States Ohio University Athens Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight change in weight 1 year
Primary Systolic Blood Pressure change in systolic blood pressure 1 year
Primary Diastolic Blood Pressure change in diastolic blood pressure 1 year
Primary Glycosylated hemoglobin change in glycosylated hemoglobin 1 year
Primary Total cholesterol change in total cholesterol 1 year
Primary low density lipoprotein cholesterol change in low density lipoprotein cholesterol 1 year
Primary triglycerides change in triglycerides 1 year
Primary high density lipoprotein cholesterol change in high density lipoprotein cholesterol 1 year
Secondary steps average number of steps per day 1 year
Secondary exercise average minutes of exercise per day 1 year
Secondary fiber average grams of fiber consumed on a daily basis 1 year
Secondary legumes average quantity of legumes consumed on a daily basis 1 year
Secondary full plate average percent of plate filled with foods high in fiber and water 1 year
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