Virtual Lifestyle Medicine Comparative Effectiveness Research

NCT ID: NCT03731481

Last Updated: 2019-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2018-07-01

Brief Summary

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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

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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.

Conditions

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Chronic Disease Obesity Sleep Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparative effectiveness research of two interventions across four cohorts
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CHIP - Urban

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

Group Type EXPERIMENTAL

Lifestyle Medicine

Intervention Type BEHAVIORAL

Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.

CHIP - Rural

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

Group Type EXPERIMENTAL

Lifestyle Medicine

Intervention Type BEHAVIORAL

Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.

FPD2- Urban

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

Group Type EXPERIMENTAL

Lifestyle Medicine

Intervention Type BEHAVIORAL

Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.

FPD2 - Rural

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

Group Type EXPERIMENTAL

Lifestyle Medicine

Intervention Type BEHAVIORAL

Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Live Healthy Appalachia

UNKNOWN

Sponsor Role collaborator

Ardmore Institute of Health

OTHER

Sponsor Role collaborator

OhioHealth

OTHER

Sponsor Role collaborator

Lifestyle Medicine Institute

UNKNOWN

Sponsor Role collaborator

Ohio University

OTHER

Sponsor Role lead

Responsible Party

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David Drozek

Assistant Professor of Surgery, Heritage College of Osteopathic Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Drozek, DO

Role: PRINCIPAL_INVESTIGATOR

Ohio University

Locations

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Ohio University

Athens, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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17-X-166

Identifier Type: -

Identifier Source: org_study_id

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