A Multidisciplinary e-Health Program to Promote Regular Physical Activity
Condition: Increased Risk for Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

Detailed description: 
      While the control of cardiovascular risk factors is essential in the prevention of
      cardiovascular disease (CVD), significant treatment gaps exist. For instance, a recent study
      of Canadian adults filling prescriptions for hypertension or dyslipidemia demonstrated that
      the majority remained overweight and sedentary despite being at increased risk of developing
      CVD.

      In Canada, there is currently a shortage of primary care physicians. Furthermore, many
      physicians have little training in helping their patients make healthy lifestyle changes such
      as losing weight or exercising regularly. Non-medical health professionals such as nurses,
      dieticians, psychologists, and kinesiologists are well trained in helping individuals modify
      their behaviour. However, they often do not have access to the health records of their
      patients or the clinical tools to translate healthy behaviours, such as increasing physical
      activity, into meaningful health outcomes, such as a reduction in blood lipids, blood
      glucose, blood pressure, or the future risk of CVD. A web-based e health program could offer
      a potential solution to fill the gap and support non-medical health professionals to become
      more effective at cardiovascular prevention.

      The MyHealthCheckUp online wellness program has been designed by a multidisciplinary team to
      improve the health of individuals at minimal cost using a web-based approach. The program's
      scientifically validated disease models have been proven to be effective in clinical
      interventions to improve the health of individuals with active health issues, such as high
      cholesterol, hypertension, and obesity, as well as low-risk individuals who want to reduce
      their risk of future problems [2, 3]. The website also features educational modules and
      physical activity, weight loss, stress management, and sleep hygiene challenges.

      The educational modules cover topics such as blood pressure management, smoking cessation,
      stress management, and weight loss. The physical activity challenge is designed to optimize
      health and wellness by promoting walking and other physical activity. As individuals or
      teams, participants track their physical activity online, and compete against each other or
      an avatar using a virtual route. The weight loss challenge is designed to promote healthy
      weight management through food and physical activity tracking as well as online information
      regarding lifestyle modification. The stress and sleep challenges are designed to help manage
      stress and improve sleep duration and quality.

      The purpose of this study is to evaluate the impact of a web-based e-health intervention,
      used by non-medical health professionals, to improve the management of cardiovascular risk
      factors including hypertension, dyslipidemia, cigarette smoking, excess body weight,
      sedentary lifestyle, as well as sleep and stress problems.

      Participants will be sent to a website where they will determine if they meet the eligibility
      criteria. If a subject meets the eligibility criteria, they will be assigned to be further
      evaluated at the McGill Comprehensive Health Improvement Program (CHIP) by one of the
      following health professionals: a nurse, dietician, kinesiologist, or psychologist (25
      subjects assigned to each health professional). Half of the participants will be randomly
      assigned to start the intervention immediately (intervention group) and the other half will
      start the intervention after the 3-month assessment (wait-list control).

      Initial Visit (approximately 45 minutes)

      At the initial visit with the health professional, informed consent will be obtained and the
      following information will be collected: demographics, medical history and concomitant
      medication, height, weight, waist circumference, sitting blood pressure, and cholesterol and
      glucose blood tests Participants will also complete the following questionnaires: The
      Physical Activity Readiness Questionnaire, Perceived Stress Scale, Insomnia Severity Index,
      and the Center for Epidemiological Studies-Depression Scale.

      Wait-List Control group

      The participants who have been randomly assigned to the wait-list control group will be given
      general documentation regarding healthy eating and physical activity from Health Canada
      (usual care) during the initial visit with the health professional. After a waiting period of
      3 months, these participants will undergo a re-evaluation with their health professional and
      will then start the intervention.

      Intervention using the e-health Website

      All participants will be given a unique temporary user name and password to access the
      MyHealthCheckUp website which is designed to assess and manage cardiovascular risk factors.
      They will also be provided with a pedometer for tracking daily steps. The health
      professionals will provide an overview of the website and discuss with the participants their
      specific goals.

      After signing on to the site, participants will have the opportunity to complete disease
      specific health risk assessments. Participants will have access to educational modules with
      information relevant to a better understanding of hypertension, dyslipidemia, and diabetes
      and the impact of lifestyle changes. Participants will also be enrolled in one of two
      lifestyle management challenges designed to motivate the user to engage in regular exercise
      or lose weight. Other challenges will be available after one of these initial challenges has
      been completed. The challenges provide education and tracking tools to facilitate the
      participant's monitoring of their own progress.

      Follow-up Visits

      All participants will be scheduled for follow-up visits at CHIP at 3 and 6 months to have
      their cardiovascular risk factors re-assessed which includes blood tests and anthropometric
      information as evaluated in the initial session. The psychosocial measures (stress, sleep and
      depressed mood) will also be re-administered at the 3 and 6 month follow-up. All intervention
      subjects will also be contacted by their study health professional at months 1, 2, 4, and 5
      either by phone or email (participant's preference) to discuss progress, barriers, and answer
      any questions. Wait control subjects will not be contacted by their health professional
      during the 3 month wait period.

      Qualitative Evaluation of the e-health Intervention

      Two focus groups, each with 10-12 patients, will be held following the intervention phase of
      this study. These focus group discussions will be facilitated to elicit in-depth feedback
      from users related to the website's acceptability and usability and to identify barriers and
      facilitators to using e-health approaches to modify lifestyle behaviours. The focus groups
      will be conducted by a trained moderator.

      A brief patient satisfaction questionnaire will be done at the end of the study to
      qualitatively assess their satisfaction of the MyHealthCheckUp website.
    

Intervention name(s): Web-based Wellness Program
Intervention type(s): Other
Intervention description(s): Web-based educational modules and physical activity and/or health weight challenges
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention