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A Multidisciplinary e-Health Program to Promote Regular Physical Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035254
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Steven Grover, MD, McGill University

Brief Summary:

In this project, individuals at risk for cardiovascular disease who are looking to lose weight or increase your level of activity, are offered access to an online lifestyle management program.

Participants will use the website daily to improve their eating and exercise habits as well as other aspects of healthy living. They will be asked to participate in online challenges to motivate them to make lifestyle changes. Participants will meet with a health professional 3 times within the 6 month time period as well as receive monthly guidance and support by phone or email for the website.


Condition or disease Intervention/treatment Phase
Increased Risk for Cardiovascular Disease Other: Web-based Wellness Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating a Multidisciplinary e-Health Program to Promote Regular Physical Activity Among Individuals at Increased Risk of Cardiovascular Disease.
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Intervention group
Web-based wellness program
Other: Web-based Wellness Program
Web-based educational modules and physical activity and/or health weight challenges

Wait control group
Web-based wellness program after 3 month wait.
Other: Web-based Wellness Program
Web-based educational modules and physical activity and/or health weight challenges




Primary Outcome Measures :
  1. 10-year cardiovascular risk [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Sleep score [ Time Frame: 3 months ]
    Score on the Insomnia Severity Index

  2. Stress Score [ Time Frame: 3-months ]
    Score on the Perceived Stress Scale

  3. Blood lipids [ Time Frame: 3 months ]
    Total cholesterol, LDL cholesterol and HDL cholesterol

  4. Blood pressure [ Time Frame: 3 months ]
  5. Body weight [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 30-75 years of age
  • Sedentary (less than 2 hours of moderate physical activity/week)
  • Have at least 1 modifiable risk factor for cardiovascular disease (e.g. elevated cholesterol, elevated blood pressure, current smoker, overweight)
  • Provided written informed consent
  • Have internet access

Exclusion Criteria:

  • Not literate in English or French
  • Have a health condition that would exclude the from being able to safely lose 10 lbs if their body mass index is > 27
  • Cannot exercise daily at a moderate intensity for at least 30 minutes
  • Are pregnant
  • Cannot access the internet at least once per week.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035254


Locations
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Canada, Quebec
McGill Comprehensive Health Improvement Program
Montreal, Quebec, Canada, H2Y 2M5
Sponsors and Collaborators
McGill University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Steven Grover, MD McGill Comprehensive Health Improvement Program
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Responsible Party: Steven Grover, MD, Director, McGill Comprehensive Health Improvement Program, McGill University
ClinicalTrials.gov Identifier: NCT02035254    
Other Study ID Numbers: CHIP1401
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Cardiovascular Diseases