CClinicalTrials.gg
CompletedNCT03739034Updated Mar 10, 2022

Evaluation of a Lifestyle Medicine Practice

An interventional study of Lifestyle Medicine in Chronic Lifestyle Related Disease, Diabetes and Overweight and Obesity, sponsored by Ohio University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Ohio University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Chronic Lifestyle Related Disease
  • Diabetes
  • Overweight and Obesity
  • Dyslipidemias
  • Hypertension
  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 71 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Ohio University is the lead sponsor of 64 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • none
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Lifestyle Medicine

    Patients presenting for lifestyle medicine treatment to prevent, arrest or reverse chronic lifestyle related diseases.

    Behavioral: Lifestyle Medicine

Interventions

  • BehavioralLifestyle Medicine

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

06

What researchers measure

Primary outcomes

  1. Weight

    change in weight

    Time frame: 1 year

  2. Systolic Blood Pressure

    change in systolic blood pressure

    Time frame: 1 year

  3. Diastolic Blood Pressure

    change in diastolic blood pressure

    Time frame: 1 year

  4. Glycosylated hemoglobin

    change in glycosylated hemoglobin

    Time frame: 1 year

  5. Total cholesterol

    change in total cholesterol

    Time frame: 1 year

  6. low density lipoprotein cholesterol

    change in low density lipoprotein cholesterol

    Time frame: 1 year

  7. triglycerides

    change in triglycerides

    Time frame: 1 year

  8. high density lipoprotein cholesterol

    change in high density lipoprotein cholesterol

    Time frame: 1 year

Secondary outcomes

  1. steps

    average number of steps per day

    Time frame: 1 year

  2. exercise

    average minutes of exercise per day

    Time frame: 1 year

  3. fiber

    average grams of fiber consumed on a daily basis

    Time frame: 1 year

  4. legumes

    average quantity of legumes consumed on a daily basis

    Time frame: 1 year

  5. full plate

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

    Time frame: 1 year

07

Study locations

1 site
  • Ohio University
    Athens, Ohio 45701, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03739034
Lead sponsor
Ohio University
Responsible party
David Drozek (Associate Professor, Ohio University) — Principal investigator
First posted
Nov 13, 2018
Start date
Jun 28, 2018
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022
Last update
Mar 10, 2022

Study contacts

David S Drozek, DO
principal investigator · Ohio University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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