Virtual Lifestyle Medicine Comparative Effectiveness Research

Not Applicable

Completed

• Conditions: Chronic Disease; Depression; Obesity; Sleep Disorder
• Interventions: Behavioral: Lifestyle Medicine

• Registration Number: NCT03731481
• Lead Sponsor: Ohio University

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.

Study Timeline

• Study Start: 2017-05-31
• Primary Completion: 2018-02-28
• Study Completion: 2018-07-01
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FPD2- Urban	Lifestyle Medicine	Participants randomized by urban location of residence to receive FPD2 Lifestyle Medicine program intervention.
CHIP - Rural	Lifestyle Medicine	Participants randomized by rural location of residence to receive CHIP Lifestyle Medicine program intervention.
CHIP - Urban	Lifestyle Medicine	Participants randomized by urban location of residence to receive CHIP Lifestyle Medicine program intervention.
FPD2 - Rural	Lifestyle Medicine	Participants randomized by rural location of residence to receive FPD2 Lifestyle Medicine program intervention.

Primary Outcome Measures

Name	Time	Method
Level of participant engagement	6 months	Measure of number of sign-ins and class attendance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ohio University; 🇺🇸 Athens, Ohio, United States