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OpenTrials
Completed

NCT Number: NCT03731481

Virtual Lifestyle Medicine Comparative Effectiveness Research

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.

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Key information

Conditions

Chronic Disease Behavior Behavioral Symptoms Body Weight Depression Disease Attributes Mental Disorders Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Medicine

Behavioral

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

Primary outcomes

  1. Level of participant engagement

    Time frame: 6 months

    Measure of number of sign-ins and class attendance

Secondary outcomes

  1. Chronic disease status

    Time frame: Baseline, 5-weeks, and 6-months from baseline

    Change in medication dosage for chronic disease conditions

  2. Psychological status

    Time frame: Baseline, 5-weeks, and 6-months from baseline

    Change in psychological state from self-reported, validated surveys

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Collaborators

  • Ardmore Institute of Health
  • Lifestyle Medicine Institute
  • Live Healthy Appalachia
  • OhioHealth

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2018
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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