Clinical trial NCT01944124: Exercise and Technology to Reduce Risk in a Rural Population With Metabolic Syndrome
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Mobile health
Metabolic syndrome
Exercise prescription
Exercise intervention
Disease prevention
Rural health
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
name: Canadian Diabetes Association
First posted: 2013-09-17
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seaforth
country: Canada
facility: Gateway Rural Health Research Institute
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Robert J Petrella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Petrella 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.
citation: Stuckey 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.