Step Monitoring to Improve ARTERial Health - Full Text View

Purpose

Many people with diabetes and/or high blood pressure (hypertension) are not very active. When people are more active, they can reduce the chances of having a heart attack or stroke. Walking more is a cheap and effective way to be more active and to lower the risk of heart attacks and strokes. The problem is that many people do not walk enough! The investigators will study if people with diabetes and/or hypertension walk more when the doctor gives them a prescription with the number of steps they should be walking every day. The investigators will compare this group, called 'active', to another group, called 'control', in which doctors and their patients do what they usually do, over a period of one year.

The investigators will measure the number of steps the investigators walk everyday with a step counter or pedometer. In the step count prescription group, the doctors will give to the 'active' group a pedometer, a step count record book, and step count prescriptions. The overall goal is to gradually increase daily steps. The speed of the increase in step count will be slower for less active people. At each visit the doctor will look at the step count record book. The doctor will then give a new step count prescription to the patients. Patients of the two groups will see their doctor about four times during the year, which is how often they usually see their doctor. At the end of one year, the investigators will see the difference in the hardness of the arteries between the 'active' and the 'control' groups, using simple and safe measurements, similar to ultrasound in pregnant ladies. People with hard arteries are more likely to have a heart attack or stroke.

The investigators suspect that patients who get the step count prescriptions will walk more and their arteries will be less hard than the control group. Our study will help find out if this is true. In that case, doctors should take the time to prescribe steps for all their patients with diabetes and/or hypertension.

Condition	Intervention	Phase
Type 2 Diabetes Hypertension	Behavioral: Step count prescription Behavioral: Usual care	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Step Monitoring to Improve ARTERial Health

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 High Blood Pressure Vascular Diseases

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

change in arterial stiffness [ Time Frame: one year ] [ Designated as safety issue: No ]
Arterial stiffness will be assessed at baseline and one year by measurement of carotid femoral pulse wave velocity through applanation tonometry.

Secondary Outcome Measures:

change in daily step count [ Time Frame: one year ] [ Designated as safety issue: No ]
Step counts will be computed at baseline and final assessments using a Yamax SW-200, based on one week of recording.
change in physical activity [ Time Frame: one year ] [ Designated as safety issue: No ]
Change in overall activity will be computed from one week of accelerometry data collected at baseline and at one year
change in physical fitness [ Time Frame: one year ] [ Designated as safety issue: No ]
Change in physical fitness will be computed using data collected through maximal exercise stress testing at baseline and one year
weight change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
Participants will be weighed at baseline and one year in light clothes, without shoes. Change in weight and percentage change in weight from baseline will be computed.
body mass index change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
Height will be measured using a mounted stadiometer. Body mass index (BMI) will be computed as weight in kg divided by height in meters squared. Change in BMI will be calculated using measurements at baseline and at one year.
change in waist circumference [ Time Frame: one year ] [ Designated as safety issue: No ]
Waist circumference will be measured midway between the iliac crest and the lower rib margin. Change in waist circumference will be computed based on data from baseline and one year.
change in waist- to- hip ratio [ Time Frame: one year ] [ Designated as safety issue: No ]
Hip circumference will be measured at the point of greatest posterior extension of the buttocks. Waist (in cm) to hip (in cm) ratio (WHR) will be computed and change in WHR will be determined using data from baseline and one year.
change in systolic blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
The participant will sit at rest for at least five minutes and then undergo blood pressure assessment using the BpTRU Blood Pressure Monitor (seated position, arm supported). The blood pressure assessments will be at two- minute intervals with the patient supine and the measurement in the right arm. The first value will be discarded and the last five measurements averaged.
change in insulin resistance [ Time Frame: one year ] [ Designated as safety issue: No ]
Using fasting glucose and fasting insulin measurements, insulin resistance will be computed using the Homeostatic Model Assessment- Insulin Resistance (HOMA- IR) equation [Fasting glucose (mmol/L) X Fasting insulin (mU/L) ÷ 22.5].
change in hemoglobin A1C in diabetes patients [ Time Frame: one year ] [ Designated as safety issue: No ]
Change in hemoglobin A1C will be ascertained for diabetes patients between baseline and one year. A1C will be measured with an HPLC analyzer.
change in total cholesterol [ Time Frame: one year ] [ Designated as safety issue: No ]
Total cholesterol will be measured using spectrophotometer at baseline and one year
change in high density lipoprotein cholesterol [ Time Frame: One year ] [ Designated as safety issue: No ]
High density lipoprotein cholesterol will be measured using spectrophotometer at baseline and one year
Change in triglyceride levels [ Time Frame: One year ] [ Designated as safety issue: No ]
Triglyceride levels will be measured using spectrophotometer at baseline and one year
change in low density lipoprotein cholesterol [ Time Frame: one year ] [ Designated as safety issue: No ]
The low density lipoprotein cholesterol will be calculated using the Friedewald equation at baseline and one year, based on total cholesterol and high density lipoprotein cholesterol values measured using spectrophotometer.
change in apolipoprotein A1 [ Time Frame: one year ] [ Designated as safety issue: No ]
Apolipoprotein A1 will be measured using the turbimetric method at baseline and one year.
change in Apolipoprotein B [ Time Frame: One year ] [ Designated as safety issue: No ]
Apolipoprotein B will be measured using the turbimetric method at baseline and one year.
change in Apolipoprotein A1 to B ratio [ Time Frame: one year ] [ Designated as safety issue: No ]
Apolipoproteins A1 and B will be measured using the turbimetric method at baseline and one year and the A1 to B ratio computed at these time points
change in total cholesterol to high density lipoprotein cholesterol ratio [ Time Frame: one year ] [ Designated as safety issue: No ]
Total cholesterol and high density lipoprotein cholesterol will be measured using spectrophotometer at baseline and at one year; the total cholesterol to high density lipoprotein cholesterol ratio will be computed at both of these time points
change in high sensitivity C-reactive protein [ Time Frame: one year ] [ Designated as safety issue: No ]
High sensitivity C-reactive protein will be assayed through an immunonephelometric method at baseline and one year
change in antihypertensive medication use [ Time Frame: one year ] [ Designated as safety issue: No ]
Investigators will assess type and dose of antihypertensive medications at baseline and one year and assess whether there has been a net increase, decrease, or no change in medication use.
change in antihyperglycemic medication [ Time Frame: one year ] [ Designated as safety issue: No ]
Investigators will assess type and dose of antihyperglycemic medications at baseline and one year and assess whether there has been a net increase, decrease, or no change in medication use.
change in lipid- lowering medications [ Time Frame: one year ] [ Designated as safety issue: No ]
Investigators will assess type and dose of lipid- lowering medications at baseline and one year and assess whether there has been a net increase, decrease, or no change in medication use.
change in diastolic blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
The participant will sit at rest for at least five minutes and then undergo blood pressure assessment using the BpTRU Blood Pressure Monitor (seated position, arm supported). The blood pressure assessments will be at two- minute intervals with the patient supine and the measurement in the right arm. The first value will be discarded and the last five measurements averaged.

Estimated Enrollment:	364
Study Start Date:	February 2012
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Step Count Prescription Arm The active trial arm intervention consists of usual care plus step count prescription delivered by the treating doctor, over a one-year period.	Behavioral: Step count prescription Treating physicians will provide a pedometer, pedometer log, and step count prescription. The aim is a net increase of at least 3,000 steps/day over one year. The time frame for this increase will be 10 months for sedentary participants (<5,000 steps/day), 7 months for low active participants (5,000-7,499 steps/day), and 5 months for somewhat active participants (7,500-9,999 steps/day). If goals are not met, the doctor and participant will review barriers and facilitators, and a more individualized prescription will be formulated (e.g. lower incremental step count targets or slower rate of dose escalation). For participants who meet goals, the doctor and participant will together decide whether to aim for a further increase.
Active Comparator: Usual care arm The control trial arm will receive usual care alone, over a one-year period (i.e. no step count prescription but, in accordance with guidelines, including advice to engage in 30-60 minutes of activity on most days of the week). Consistent with clinical practice guidelines, our collaborating doctors have indicated that the usual care of the target population requires clinic visits at roughly three-month intervals to ensure vascular risk factor monitoring and management.	Behavioral: Usual care The control trial arm will receive usual care alone, over a one-year period (i.e. no step count prescription but, in accordance with guidelines, including advice to engage in 30-60 minutes of activity on most days of the week).

Arms

Assigned Interventions

Experimental: Step Count Prescription Arm

The active trial arm intervention consists of usual care plus step count prescription delivered by the treating doctor, over a one-year period.

Behavioral: Step count prescription

Treating physicians will provide a pedometer, pedometer log, and step count prescription. The aim is a net increase of at least 3,000 steps/day over one year. The time frame for this increase will be 10 months for sedentary participants (<5,000 steps/day), 7 months for low active participants (5,000-7,499 steps/day), and 5 months for somewhat active participants (7,500-9,999 steps/day). If goals are not met, the doctor and participant will review barriers and facilitators, and a more individualized prescription will be formulated (e.g. lower incremental step count targets or slower rate of dose escalation). For participants who meet goals, the doctor and participant will together decide whether to aim for a further increase.

Active Comparator: Usual care arm

The control trial arm will receive usual care alone, over a one-year period (i.e. no step count prescription but, in accordance with guidelines, including advice to engage in 30-60 minutes of activity on most days of the week). Consistent with clinical practice guidelines, our collaborating doctors have indicated that the usual care of the target population requires clinic visits at roughly three-month intervals to ensure vascular risk factor monitoring and management.

Behavioral: Usual care

The control trial arm will receive usual care alone, over a one-year period (i.e. no step count prescription but, in accordance with guidelines, including advice to engage in 30-60 minutes of activity on most days of the week).

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Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Followed by a SMARTER collaborating doctor
BMI ≥ 25 kg/m2 but < 40 kg/m2 (i.e. overweight to class II obese)
Type 2 diabetes and/or hypertension
Conversant in either English or French

Exclusion Criteria:

≥ 150 minutes of leisure time physical activity per week be self- report
Acute or chronic co-morbid conditions that may affect the ability or likelihood to adhere to trial procedures (e.g. inflammatory arthritis, active malignancy, major depression or other significant psychiatric disorders, and/or significant visual impairment)
Pregnancy/planning a pregnancy
Baseline step count averaging ≥ 10,000 steps/day at baseline assessment
Arrhythmia that prevents accurate assessment of carotid-femoral pulse wave velocity (e.g., atrial fibrillation)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475201

Contacts

Contact: Debbie Chan, BSc

514-934-1934 ext 44835

debbie.chan@clinepi.mcgill.ca

Locations

Canada, Quebec
St. Mary's Hospital Center	Recruiting
Montreal, Quebec, Canada, H3T 1M5
Contact: Cindy Ibberson, BA 514-345-3511 ext 5593 cindy.ibberson@ssss.gouv.qc.ca
Contact: Ellen Rosenberg, MD 514-345-3511 ext 5620 ellen.rosenberg@mcgill.ca
Principal Investigator: Ellen Rosenberg, MD
Lakeshore General Hospital	Recruiting
Montreal, Quebec, Canada, H9R 2Y2
Contact: Henry Jay Biem, MD biemh@videotron.ca
Principal Investigator: Henry Jay Biem, MD
Jewish General Hospital	Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Debbie Chan, BSc 5149341934 debbie.chan@clinepi.mcgill.ca
Principal Investigator: Roland Grad, MD, MSc
Principal Investigator: Stavroula Christopoulos, MD
McGill University Health Centre - Royal Victoria Hosptial	Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Debbie Chan, BSc 514-934-1934 ext 44835 debbie.chan@clinepi.mcgill.ca
Principal Investigator: Kaberi Dasgupta, MD, MSc
McGill University Health Centre - Montreal General Hospital	Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Debbie Chan, BSc 514-934-1934 ext 44835 debbie.chan@clinepi.mcgill.ca
Principal Investigator: Stella Daskalopoulou, MD

Sponsors and Collaborators

McGill University Health Center

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:	Kaberi Dasgupta, MD, MSc	McGill University and McGill University Health Centre
Principal Investigator:	Stella Daskalopoulou, MD, PhD	McGill University and McGill University Health Centre
Principal Investigator:	Ellen Rosenberg, MD	McGill University and St. Mary's Hospital Center

More Information

No publications provided

Responsible Party:	Kaberi Dasgupta, MD, MSc, FRCP (C), Associate Professor of Medicine and Physician Scientist, McGill University Health Center
ClinicalTrials.gov Identifier:	NCT01475201 History of Changes
Other Study ID Numbers:	CIHR-MOP-114996
Study First Received:	November 16, 2011
Last Updated:	February 4, 2013
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

Type 2 diabetes
Hypertension
Primary Care
Physical Activity
Behavioural Intervention
Pedometer

Accelerometer
Arterial Stiffness
Carotid femoral pulse wave velocity
Vascular disease risk
Vascular disease prevention
Intervention

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

Step Monitoring to Improve ARTERial Health (SMARTER)