Virtual Lifestyle Medicine Comparative Effectiveness Research

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731481
• Other study ID #: 17-X-166
• Status: Completed
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: November 2019
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 1, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Depression
• Obesity
• Sleep Disorder
• Sleep Wake Disorders

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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
Ohio University	Ardmore Institute of Health, Lifestyle Medicine Institute, Live Healthy Appalachia, OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of participant engagement	Measure of number of sign-ins and class attendance	6 months
Secondary	Chronic disease status	Change in medication dosage for chronic disease conditions	Baseline, 5-weeks, and 6-months from baseline
Secondary	Psychological status	Change in psychological state from self-reported, validated surveys	Baseline, 5-weeks, and 6-months from baseline