Metabolic Syndrome XNCT01944124
Exercise and Technology to Reduce Risk in a Rural Population With Metabolic Syndrome
A study testing Mobile Health and Exercise Prescription in people with Metabolic Syndrome X, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Cardiovascular diseases are the leading cause of death among Canadians. In those with diabetes, cardiovascular complications are responsible for more than 70% of deaths. While there is much interest in identifying and treating risk factors, the exact biological mechanisms, their measurement and optimal ways to prevent… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Mobile Health and Exercise Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-70 years
- two or more metabolic syndrome risk factors according to National Cholesterol Education Program Adult Treatment Panel III criteria: waist circumference ≥ 88 cm (women) or ≥ 102 cm (men); systolic blood pressure ≥ 135 mmHg and/or diastolic blood pressure ≥ 85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L; triglycerides ≥ 1.7 mmol/L; and high density lipoprotein cholesterol ≤ 1.29 mmol/L (women) or ≤ 1.02 mmol/L (men)
Who cannot join
- systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110mmHg
- type 1 diabetes
- history of myocardial infarction, angioplasty, coronary artery bypass or cerebrovascular ischemia/stroke
- symptomatic congestive heart failure
- atrial flutter
- unstable angina
Show all 12Show fewer
- unstable pulmonary disease
- use of medications known to affect heart rate
- second or third degree heart block
- history of alcoholism, drug abuse or other emotional cognitive or psychiatric problems
- pacemaker
- unstable metabolic disease and orthopedic or rheumatologic problems that could impair the ability to exercise
Trial locations and contacts
1 site in 1 country.
Canada1 site
Gateway Rural Health Research Institute
Seaforth, Ontario, N0K 1W0
About this study
Official title: A Lifestyle Intervention Supported by Mobile Health Technologies to Improve the Cardiometabolic Risk Profile of Individuals at Risk for Cardiovascular Disease and Type 2 Diabetes.
Cardiovascular diseases are the leading cause of death among Canadians. In those with diabetes, cardiovascular complications are responsible for more than 70% of deaths. While there is much interest in identifying and treating risk factors, the exact biological mechanisms, their measurement and optimal ways to prevent and manage them are poorly understood.
Physical activity and regular exercise can prevent diabetes and effectively manage risk factors, but most Canadians do not exercise enough to beneficially manage risk. Tailored exercise prescribed by a family physician has shown promise as a means to increase fitness and reduce risk, but optimal implementation practices remain unknown - especially in rural and remote communities with reduced access to healthcare. Mobile health technologies have proved to be a beneficial tool to achieve blood pressure and blood glucose control in patients with diabetes. These technologies may address the limited access to health interventions in rural and remote regions. However, the potential as a tool to support exercise-based prevention activities unknown.
Read more
Therefore, this study was undertaken to investigate the effects of a tailored exercise prescription alone or supported by mobile health technologies to improve cardiovascular risk factors in rural community-dwelling adults at risk for cardiovascular disease and type 2 diabetes.
Adults with cardiovascular risk factors were recruited from rural communities and randomized to either: 1) an intervention group receiving an exercise prescription and devices for monitoring of risk factors with a smartphone data portal equipped with a mobile health application; or 2) an active control group receiving only an exercise prescription.
It was hypothesized that the intervention group would reduce their risk to a greater extent than the active control group following 12 weeks, and that these improvements would be better maintained in the intervention group at 24 and 52 weeks compared to the active control group.
- Conditions
- Metabolic Syndrome X
- Being tested
- Mobile Health, Exercise Prescription
- Keywords
- Mobile health, Metabolic syndrome, Exercise prescription, Exercise intervention, Disease prevention, Rural health
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile HealthBehavioural
Participants monitored their blood pressure 3x per week, blood glucose 1x per week, pedometer steps daily and body weight monthly. Measures from devices were transferred or inputted to a smartphone data portal. Planned exercise was logged electronically on the smartphone.
Exercise PrescriptionBehavioural
An exercise program was prescribed tailored to participant fitness level (using the Step Test Exercise Prescription (STEP-TM) protocol). Briefly, STEP-TM required participants to step up and down a set of 2 steps 20 times at a comfortable pace. A predictive equation including post-test heart rate, time to complete test, age, body weight and sex was used to calculate fitness. An exercise program was prescribed including aerobic exercise most days of the week for 30-60 minutes in duration at a target heart rate tailored to fitness level. Light resistance training was also prescribed 2-4 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Prescription + Mobile Health | Experimental | Received a tailored exercise prescription and mobile health technology kit to track blood pressure, blood glucose, physical activity and body weight. Receives: Behavioral: Mobile Health; Behavioral: Exercise Prescription |
| Exercise Prescription | Active comparator | Received a tailored exercise prescription only. Receives: Behavioral: Exercise Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Canadian Diabetes Association
- Responsible party
- Principal investigator, Rob Petrella, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Robert J Petrella, MD, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944124
- Sponsor's protocol ID
- 15828
- Status last verified
- Oct 2013
- First submitted
- 12 Sep 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Stuckey MI, Gill DP, Petrella RJ. Does Systolic Blood Pressure Response to Lifestyle Intervention Indicate Metabolic Risk and Health-Related Quality-of-Life Improvement Over 1 Year? J Clin Hypertens (Greenwich). 2015 May;17(5):375-80. doi: 10.1111/jch.12531. Epub 2015 Mar 10.
PubMed 25757039Petrella RJ, Stuckey MI, Shapiro S, Gill DP. Mobile health, exercise and metabolic risk: a randomized controlled trial. BMC Public Health. 2014 Oct 18;14:1082. doi: 10.1186/1471-2458-14-1082.
PubMed 25326074Stuckey MI, Shapiro S, Gill DP, Petrella RJ. A lifestyle intervention supported by mobile health technologies to improve the cardiometabolic risk profile of individuals at risk for cardiovascular disease and type 2 diabetes: study rationale and protocol. BMC Public Health. 2013 Nov 7;13:1051. doi: 10.1186/1471-2458-13-1051.
PubMed 24199747
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lifestyle Intervention Supported by Mobile Health Technologies to Improve the Cardiometabolic Risk Profile of Individuals at Risk for Cardiovascular Disease and Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT01944124
- Acronym / sponsor ID
- 15828
- Conditions
- Metabolic Syndrome X
- Keywords
- Mobile health, Metabolic syndrome, Exercise prescription, Exercise intervention, Disease prevention, Rural health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Canadian Diabetes Association
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular diseases are the leading cause of death among Canadians. In those with diabetes, cardiovascular complications are responsible for more than 70% of deaths. While there is much interest in identifying and treating risk factors, the exact biological mechanisms, their measurement and optimal ways to prevent and manage them are poorly understood.
Physical activity and regular exercise can prevent diabetes and effectively manage risk factors, but most Canadians do not exercise enough to beneficially manage risk. Tailored exercise prescribed by a family physician has shown promise as a means to increase fitness and reduce risk, but optimal implementation practices remain unknown - especially in rural and remote communities with reduced access to healthcare. Mobile health technologies have proved to be a beneficial tool to achieve blood pressure and blood glucose control in patients with diabetes. These technologies may address the limited access to health interventions in rural and remote regions. However, the potential as a tool to support exercise-based prevention activities unknown.
Therefore, this study was undertaken to investigate the effects of a tailored exercise prescription alone or supported by mobile health technologies to improve cardiovascular risk factors in rural community-dwelling adults at risk for cardiovascular disease and type 2 diabetes.
Adults with cardiovascular risk factors were recruited from rural communities and randomized to either: 1) an intervention group receiving an exercise prescription and devices for monitoring of risk factors with a smartphone data portal equipped with a mobile health application; or 2) an active control group receiving only an exercise prescription.
It was hypothesized that the intervention group would reduce their risk to a greater extent than the active control group following 12 weeks, and that these improvements would be better maintained in the intervention group at 24 and 52 weeks compared to the active control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Prescription + Mobile Health | Experimental | Behavioral: Mobile Health, Behavioral: Exercise PrescriptionReceived a tailored exercise prescription and mobile health technology kit to track blood pressure, blood glucose, physical activity and body weight. |
| Exercise Prescription | Active comparator | Behavioral: Exercise PrescriptionReceived a tailored exercise prescription only. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18-70 years
- two or more metabolic syndrome risk factors according to National Cholesterol Education Program Adult Treatment Panel III criteria: waist circumference ≥ 88 cm (women) or ≥ 102 cm (men); systolic blood pressure ≥ 135 mmHg and/or diastolic blood pressure ≥ 85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L; triglycerides ≥ 1.7 mmol/L; and high density lipoprotein cholesterol ≤ 1.29 mmol/L (women) or ≤ 1.02 mmol/L (men)
Key exclusion criteria (12 listed)
- systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110mmHg
- type 1 diabetes
- history of myocardial infarction, angioplasty, coronary artery bypass or cerebrovascular ischemia/stroke
- symptomatic congestive heart failure
- atrial flutter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile HealthParticipants monitored their blood pressure 3x per week, blood glucose 1x per week, pedometer steps daily and body weight monthly. Measures from devices were transferred or inputted to a smartphone data portal. Planned exercise was logged electronically on the smartphone. | Behavioural | Exercise Prescription + Mobile Health |
| Exercise PrescriptionAn exercise program was prescribed tailored to participant fitness level (using the Step Test Exercise Prescription (STEP-TM) protocol). Briefly, STEP-TM required participants to step up and down a set of 2 steps 20 times at a comfortable pace. A predictive equation including post-test heart rate, time to complete test, age, body weight and sex was used to calculate fitness. An exercise program was prescribed including aerobic exercise most days of the week for 30-60 minutes in duration at a target heart rate tailored to fitness level. Light resistance training was also prescribed 2-4 times per week. | Behavioural | Exercise Prescription, Exercise Prescription + Mobile Health |
Primary outcome
Systolic Blood Pressure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
- Derived from this study: PubMed 25757039Stuckey MI, Gill DP, Petrella RJ. Does Systolic Blood Pressure Response to Lifestyle Intervention Indicate Metabolic Risk and Health-Related Quality-of-Life Improvement Over 1 Year? J Clin Hypertens (Greenwich). 2015 May;17(5):375-80. doi: 10.1111/jch.12531. Epub 2015 Mar 10.
- Derived from this study: PubMed 25326074Petrella RJ, Stuckey MI, Shapiro S, Gill DP. Mobile health, exercise and metabolic risk: a randomized controlled trial. BMC Public Health. 2014 Oct 18;14:1082. doi: 10.1186/1471-2458-14-1082.
- Derived from this study: PubMed 24199747Stuckey MI, Shapiro S, Gill DP, Petrella RJ. A lifestyle intervention supported by mobile health technologies to improve the cardiometabolic risk profile of individuals at risk for cardiovascular disease and type 2 diabetes: study rationale and protocol. BMC Public Health. 2013 Nov 7;13:1051. doi: 10.1186/1471-2458-13-1051.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Petrella, MD, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health and Exercise Prescription in people with Metabolic Syndrome X, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944124, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.