Evaluation of a Lifestyle Medicine Practice

• Sponsor: Ohio University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03739034
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arm: 1
• Actual Duration (Months): 44.1
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Lifestyle Related Disease; Diabetes; Overweight and Obesity; Dyslipidemias; Hypertension; Cardiovascular Diseases	Behavioral: Lifestyle Medicine	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients are being treated with established lifestyle medicine modalities, tailored to the individual patient need and situation.Patients are being treated with established lifestyle medicine modalities, tailored to the individual patient need and situation.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of a Lifestyle Medicine Practice
• Actual Study Start Date: Jun 28, 2018
• Actual Primary Completion Date: Mar 1, 2022
• Actual Study Completion Date: Mar 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Weight [1 year]

   change in weight

2. Systolic Blood Pressure [1 year]

   change in systolic blood pressure

3. Diastolic Blood Pressure [1 year]

   change in diastolic blood pressure

4. Glycosylated hemoglobin [1 year]

   change in glycosylated hemoglobin

5. Total cholesterol [1 year]

   change in total cholesterol

6. low density lipoprotein cholesterol [1 year]

   change in low density lipoprotein cholesterol

7. triglycerides [1 year]

   change in triglycerides

8. high density lipoprotein cholesterol [1 year]

   change in high density lipoprotein cholesterol

Secondary Outcome Measures

1. steps [1 year]

   average number of steps per day

2. exercise [1 year]

   average minutes of exercise per day

3. fiber [1 year]

   average grams of fiber consumed on a daily basis

4. legumes [1 year]

   average quantity of legumes consumed on a daily basis

5. full plate [1 year]

   average percent of plate filled with foods high in fiber and water

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio University	Athens	Ohio	United States	45701

Sponsors and Collaborators

• Ohio University

Investigators

• Principal Investigator: David S Drozek, DO, Ohio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Drozek, Associate Professor, Ohio University
• ClinicalTrials.gov Identifier: NCT03739034
• Other Study ID Numbers: 18-X-220
• First Posted: Nov 13, 2018
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases; Dyslipidemias; Overweight

Study Results

No Results Posted as of Mar 10, 2022