HealtheSteps™ Study Protocol: a pragmatic randomized controlled trial promoting active living and healthy lifestyles in at-risk Canadian adults delivered in primary care and community-based clinics.
Physical inactivity is one of the leading causes of chronic disease in Canadian adults. With less than 50% of Canadian adults reaching the recommended amount of daily physical activity, there is an urgent need for effective programs targeting this risk factor. HealtheSteps™ is a healthy lifestyle prescription program, developed from an extensive research base to address risk factors for chronic disease such as physical inactivity, sedentary behaviour and poor eating habits. HealtheSteps™ participants are provided with in-person lifestyle coaching and access to eHealth technologies delivered in community-based primary care clinics and health care organizations.



To determine the effectiveness of Healthesteps™, we will conduct a 6-month pragmatic randomized controlled trial with integrated process and economic evaluations of HealtheSteps™ in 5 clinic settings in Southwestern Ontario. 110 participants will be individually randomized (1:1; stratified by site) to either the intervention (HealtheSteps™ program) or comparator (Wait-list control). There are 3 phases of the HealtheSteps™ program, lasting 6 months each. The active phase consists of bi-monthly in-person coaching with access to a full suite of eHealth technology supports. During the maintenance phase I, the in-person coaching will be removed, but participants will still have access to the full suite of eHealth technology supports. In the final stage, maintenance phase II, access to the full suite of eHealth technology supports is removed and participants only have access to publicly available resources and tools.



This trial aims to determine the effectiveness of the program in increasing physical activity levels and improving other health behaviours and indicators, the acceptability of the HealtheSteps™ program, and the direct cost for each person participating in the program as well as the costs associated with delivering the program at the different community sites. These results will inform future optimization and scaling up of the program into additional community-based primary care sites.



NCT02413385 (Clinicaltrials.gov). Date Registered: April 6, 2015.
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada.|Lawson Health Research Institute, London, Ontario, Canada.|School of Health Studies, Faculty of Health Sciences, Western University, London, Ontario, Canada.
Dawn P
DP
Gill
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada.|Lawson Health Research Institute, London, Ontario, Canada.
Wendy
W
Blunt
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada.|Lawson Health Research Institute, London, Ontario, Canada.
Cassandra
C
Bartol
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada.|Lawson Health Research Institute, London, Ontario, Canada.
Roseanne W
RW
Pulford
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada.|Lawson Health Research Institute, London, Ontario, Canada.
Ashleigh
A
De Cruz
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada.|Lawson Health Research Institute, London, Ontario, Canada.
P Karen
PK
Simmavong
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada.|Lawson Health Research Institute, London, Ontario, Canada.|School of Public Health, Brown University, Providence, Road Island, USA.
Adam
A
Gavarkovs
School of Kinesiology, Lakehead University, Thunder Bay, Ontario, Canada.
Ian
I
Newhouse
School of Kinesiology, Lakehead University, Thunder Bay, Ontario, Canada.
Erin
E
Pearson
Centre for Education and Research on Aging and Health, Lakehead University, Thunder Bay, Ontario, Canada.
Bayley
B
Ostenfeldt
School of Physical and Health Education, Nipissing University, North Bay, Ontario, Canada.
Barbi
B
Law
School of Physical and Health Education, Nipissing University, North Bay, Ontario, Canada.
Kristina
K
Karvinen
Aurora Research Institute, Aurora College, Yellowknife, Northwest Territories, Canada.
Pertice
P
Moffit
School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.
Gareth
G
Jones
Northwest Local Health Integration Network, Chronic Disease, Health and Design Development, Thunder Bay, Ontario, Canada.
Cori
C
Watson
Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.|Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada.
Guangyong
G
Zou
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada. petrella@uwo.ca.|Lawson Health Research Institute, London, Ontario, Canada. petrella@uwo.ca.|School of Kinesiology, Faculty of Health Sciences, Western University, London, Ontario, Canada. petrella@uwo.ca.
Robert J
RJ
Petrella
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002170:Canada; D003153:Community Health Services / Q000379:methods*; D005260:Female; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods* / Q000706:statistics & numerical data; D000070497:Healthy Lifestyle; D006801:Humans; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care / Q000379:methods*; D015397:Program Evaluation / Q000706:statistics & numerical data*; D055815:Young Adult
Behaviour change; Chronic disease prevention and management; Health technology; Healthy eating; Lifestyle coaching; Physical activity; Primary care intervention; Sedentary behaviour