Virtual Lifestyle Medicine Comparative Effectiveness Research

November 13, 2019 updated by: David Drozek, Ohio University

Comparing the Effectiveness of Two Virtual Lifestyle Medicine Interventions Across Urban and Rural Settings

This study evaluates the effectiveness of two online Lifestyle Medicine programs. Participants will be randomized by residence, urban vs. rural, into one of two Lifestyle Medicine programs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study compares the effectiveness of two virtual Lifestyle Medicine programs across two settings: urban and rural. Program materials include nutritional education, methods to reduce personal stress, and incorporation of physical activity in daily routine. Bio-marker and subjective/self-reported survey measures will be collected at baseline, 5-weeks and six-months from baseline. Study seeks to measure variations in participant outcomes across two lifestyle interventions, participant engagement and level of adherence.

Study Type

Interventional

Enrollment (Actual)

46

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Able to read and write English
  • Access to high-speed Internet
  • Taking medication for at least one chronic disease condition such as high blood pressure, OR are overweight (BMI of 25 or greater)
  • Willing to provide blood samples at three time points
  • Willing to complete online surveys at three time points

Exclusion Criteria:

  • Advised by physician to limit physical activity
  • Previous experience with lifestyle medicine programs, specifically Lifestyle Medicine Clinic, Complete Health Improvement Program, Full Plate Diet
  • Household includes someone who has previous experience with a Lifestyle Medicine program

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHIP - Urban
Participants randomized by urban location of residence to receive CHIP Lifestyle Medicine program intervention.
Behavioral: Lifestyle Medicine
Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.
Experimental: CHIP - Rural
Participants randomized by rural location of residence to receive CHIP Lifestyle Medicine program intervention.
Behavioral: Lifestyle Medicine
Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.
Experimental: FPD2- Urban
Participants randomized by urban location of residence to receive FPD2 Lifestyle Medicine program intervention.
Behavioral: Lifestyle Medicine
Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.
Experimental: FPD2 - Rural
Participants randomized by rural location of residence to receive FPD2 Lifestyle Medicine program intervention.
Behavioral: Lifestyle Medicine
Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of participant engagement
Time Frame: 6 months
Measure of number of sign-ins and class attendance
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic disease status
Time Frame: Baseline, 5-weeks, and 6-months from baseline
Change in medication dosage for chronic disease conditions
Baseline, 5-weeks, and 6-months from baseline
Psychological status
Time Frame: Baseline, 5-weeks, and 6-months from baseline
Change in psychological state from self-reported, validated surveys
Baseline, 5-weeks, and 6-months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio University

Collaborators

OhioHealth
Ardmore Institute of Health
Live Healthy Appalachia
Lifestyle Medicine Institute

Investigators

  • Principal Investigator: David Drozek, DO, 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)

May 31, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-X-166

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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