Virtual Lifestyle Medicine Comparative Effectiveness Research

Study Overview
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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.

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

Conditions
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Chronic Disease, Obesity, Sleep Disorder, Depression

Intervention / Treatment
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* Behavioral: Lifestyle Medicine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparative effectiveness research of two interventions across four cohorts
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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