Step Monitoring to Improve ARTERial Health

NCT01475201 | Completed

• 1 other identifier: CIHR-MOP-114996
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Type 2 Diabetes; Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• change in arterial stiffness

  Arterial stiffness will be assessed at baseline and one year by measurement of carotid femoral pulse wave velocity through applanation tonometry.

  one year

Secondary Outcomes (23)

• change in daily step count

  one year

• change in physical activity

  one year

• change in physical fitness

  one year

• weight change from baseline

  one year

• body mass index change from baseline

  one year

Study Arms (2)

Step Count Prescription Arm

EXPERIMENTAL

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

Usual care arm

ACTIVE COMPARATOR

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

Interventions

Step count prescription BEHAVIORAL

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.

Step Count Prescription Arm

Usual care BEHAVIORAL

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).

Usual care arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ≥ 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

McGill University Health Centre - Royal Victoria Hosptial

Montreal, Quebec, H3A 1A1, Canada

Location

McGill University Health Centre - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

Lakeshore General Hospital

Montreal, Quebec, H9R 2Y2, Canada

Location

Related Publications (6)

• Cooke AB, Daskalopoulou SS, Dasgupta K. The impact of accelerometer wear location on the relationship between step counts and arterial stiffness in adults treated for hypertension and diabetes. J Sci Med Sport. 2018 Apr;21(4):398-403. doi: 10.1016/j.jsams.2017.08.011. Epub 2017 Aug 24.

  PMID: 28855085 BACKGROUND

• Cooke AB, Pace R, Chan D, Rosenberg E, Dasgupta K, Daskalopoulou SS. A qualitative evaluation of a physician-delivered pedometer-based step count prescription strategy with insight from participants and treating physicians. Diabetes Res Clin Pract. 2018 May;139:314-322. doi: 10.1016/j.diabres.2018.03.008. Epub 2018 Mar 10.

  PMID: 29530385 BACKGROUND

• Dasgupta K, Rosenberg E, Daskalopoulou SS; SMARTER collaborators. Step Monitoring to improve ARTERial health (SMARTER) through step count prescription in type 2 diabetes and hypertension: trial design and methods. Cardiovasc Diabetol. 2014 Jan 6;13:7. doi: 10.1186/1475-2840-13-7.

  PMID: 24393423 BACKGROUND

• Hajna S, Kestens Y, Daskalopoulou SS, Joseph L, Thierry B, Sherman M, Trudeau L, Rabasa-Lhoret R, Meissner L, Bacon SL, Gauvin L, Ross NA, Dasgupta K; Diabetes, GPS, and Walkablilty Study Group. Neighbourhood walkability and home neighbourhood-based physical activity: an observational study of adults with type 2 diabetes. BMC Public Health. 2016 Sep 9;16(1):957. doi: 10.1186/s12889-016-3603-y.

  PMID: 27613233 BACKGROUND

• Dasgupta K, Rosenberg E, Joseph L, Cooke AB, Trudeau L, Bacon SL, Chan D, Sherman M, Rabasa-Lhoret R, Daskalopoulou SS; SMARTER Trial Group. Physician step prescription and monitoring to improve ARTERial health (SMARTER): A randomized controlled trial in patients with type 2 diabetes and hypertension. Diabetes Obes Metab. 2017 May;19(5):695-704. doi: 10.1111/dom.12874. Epub 2017 Feb 22.

  PMID: 28074635 BACKGROUND

• Dasgupta K, Rosenberg E, Joseph L, Trudeau L, Garfield N, Chan D, Sherman M, Rabasa-Lhoret R, Daskalopoulou SS. Carotid femoral pulse wave velocity in type 2 diabetes and hypertension: capturing arterial health effects of step counts. J Hypertens. 2017 May;35(5):1061-1069. doi: 10.1097/HJH.0000000000001277.

  PMID: 28129250 BACKGROUND

Related Links

• BMC Public Health paper
• Cardiovascular Diabetololy paper

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Physician Scientist

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 21, 2011
• Study Start: February 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)