NCT03739034

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

3.7 years

First QC Date

November 8, 2018

Last Update Submit

March 9, 2022

Conditions

Chronic Lifestyle Related DiseaseDiabetesOverweight and ObesityDyslipidemiasHypertensionCardiovascular Diseases

Outcome Measures

Primary Outcomes (8)

  • Weight

    change in weight

    1 year

  • Systolic Blood Pressure

    change in systolic blood pressure

    1 year

  • Diastolic Blood Pressure

    change in diastolic blood pressure

    1 year

  • Glycosylated hemoglobin

    change in glycosylated hemoglobin

    1 year

  • Total cholesterol

    change in total cholesterol

    1 year

  • low density lipoprotein cholesterol

    change in low density lipoprotein cholesterol

    1 year

  • triglycerides

    change in triglycerides

    1 year

  • high density lipoprotein cholesterol

    change in high density lipoprotein cholesterol

    1 year

Secondary Outcomes (5)

  • steps

    1 year

  • exercise

    1 year

  • fiber

    1 year

  • legumes

    1 year

  • full plate

    1 year

Study Arms (1)

Lifestyle Medicine

EXPERIMENTAL

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

Behavioral: Lifestyle Medicine

Interventions

Lifestyle MedicineBEHAVIORAL

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

Lifestyle Medicine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Diabetes MellitusOverweightObesityDyslipidemiasHypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersVascular Diseases

Study Officials

  • David S Drozek, DO

    Ohio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients are being treated with established lifestyle medicine modalities, tailored to the individual patient need and situation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 13, 2018

Study Start

June 28, 2018

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)