Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02035254 |
| Other study ID # |
CHIP1401 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 10, 2014 |
| Last updated |
April 7, 2015 |
| Start date |
November 2013 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
April 2015 |
| Source |
McGill University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Ethics Review Committee |
| Study type |
Interventional
|
Clinical Trial 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.
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.
