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Virtual Lifestyle Medicine Comparative Effectiveness Research

Primary Purpose

Chronic Disease, Obesity, Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Medicine
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

CHIP - Urban

CHIP - Rural

FPD2- Urban

FPD2 - Rural

Arm Description

Participants randomized by urban location of residence to receive CHIP Lifestyle Medicine program intervention.

Participants randomized by rural location of residence to receive CHIP Lifestyle Medicine program intervention.

Participants randomized by urban location of residence to receive FPD2 Lifestyle Medicine program intervention.

Participants randomized by rural location of residence to receive FPD2 Lifestyle Medicine program intervention.

Outcomes

Primary Outcome Measures

Level of participant engagement
Measure of number of sign-ins and class attendance

Secondary Outcome Measures

Chronic disease status
Change in medication dosage for chronic disease conditions
Psychological status
Change in psychological state from self-reported, validated surveys

Full Information

First Posted
October 31, 2018
Last Updated
November 13, 2019
Sponsor
Ohio University
Collaborators
Live Healthy Appalachia, Ardmore Institute of Health, OhioHealth, Lifestyle Medicine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03731481
Brief Title
Virtual Lifestyle Medicine Comparative Effectiveness Research
Official Title
Comparing the Effectiveness of Two Virtual Lifestyle Medicine Interventions Across Urban and Rural Settings
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University
Collaborators
Live Healthy Appalachia, Ardmore Institute of Health, OhioHealth, Lifestyle Medicine Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Obesity, Sleep Disorder, Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparative effectiveness research of two interventions across four cohorts
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHIP - Urban
Arm Type
Experimental
Arm Description
Participants randomized by urban location of residence to receive CHIP Lifestyle Medicine program intervention.
Arm Title
CHIP - Rural
Arm Type
Experimental
Arm Description
Participants randomized by rural location of residence to receive CHIP Lifestyle Medicine program intervention.
Arm Title
FPD2- Urban
Arm Type
Experimental
Arm Description
Participants randomized by urban location of residence to receive FPD2 Lifestyle Medicine program intervention.
Arm Title
FPD2 - Rural
Arm Type
Experimental
Arm Description
Participants randomized by rural location of residence to receive FPD2 Lifestyle Medicine program intervention.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Medicine
Intervention Description
Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.
Primary Outcome Measure Information:
Title
Level of participant engagement
Description
Measure of number of sign-ins and class attendance
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Chronic disease status
Description
Change in medication dosage for chronic disease conditions
Time Frame
Baseline, 5-weeks, and 6-months from baseline
Title
Psychological status
Description
Change in psychological state from self-reported, validated surveys
Time Frame
Baseline, 5-weeks, and 6-months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Drozek, DO
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Lifestyle Medicine Comparative Effectiveness Research

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