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

Dawn P Gill; Wendy Blunt; Cassandra Bartol; Roseanne W Pulford; Ashleigh De Cruz; P Karen Simmavong; Adam Gavarkovs; Ian Newhouse; Erin Pearson; Bayley Ostenfeldt; Barbi Law; Kristina Karvinen; Pertice Moffit; Gareth Jones; Cori Watson; Guangyong Zou; Robert J Petrella

doi:10.1186/s12889-017-4047-8

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

BMC Public Health. 2017 Feb 7;17(1):173. doi: 10.1186/s12889-017-4047-8.

Authors

Dawn P Gill^{1

2

3}, Wendy Blunt^{1

2}, Cassandra Bartol^{1

2}, Roseanne W Pulford^{1

2}, Ashleigh De Cruz^{1

2}, P Karen Simmavong^{1

2}, Adam Gavarkovs^{1

2

4}, Ian Newhouse⁵, Erin Pearson⁵, Bayley Ostenfeldt⁶, Barbi Law⁷, Kristina Karvinen⁷, Pertice Moffit⁸, Gareth Jones⁹, Cori Watson¹⁰, Guangyong Zou^{11

12}, Robert J Petrella^{13

14

15}

Affiliations

¹ 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.
² Lawson Health Research Institute, London, Ontario, Canada.
³ School of Health Studies, Faculty of Health Sciences, Western University, London, Ontario, Canada.
⁴ School of Public Health, Brown University, Providence, Road Island, USA.
⁵ School of Kinesiology, Lakehead University, Thunder Bay, Ontario, Canada.
⁶ Centre for Education and Research on Aging and Health, Lakehead University, Thunder Bay, Ontario, Canada.
⁷ School of Physical and Health Education, Nipissing University, North Bay, Ontario, Canada.
⁸ Aurora Research Institute, Aurora College, Yellowknife, Northwest Territories, Canada.
⁹ School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.
¹⁰ Northwest Local Health Integration Network, Chronic Disease, Health and Design Development, Thunder Bay, Ontario, Canada.
¹¹ Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
¹² Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada.
¹³ 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.
¹⁴ Lawson Health Research Institute, London, Ontario, Canada. petrella@uwo.ca.
¹⁵ School of Kinesiology, Faculty of Health Sciences, Western University, London, Ontario, Canada. petrella@uwo.ca.

Abstract

Background: 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.

Method/design: 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.

Discussion: 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.

Trial registration: NCT02413385 (Clinicaltrials.gov). Date Registered: April 6, 2015.

Keywords: Behaviour change; Chronic disease prevention and management; Health technology; Healthy eating; Lifestyle coaching; Physical activity; Primary care intervention; Sedentary behaviour.

Publication types

Randomized Controlled Trial

MeSH terms

Adolescent
Adult
Aged
Aged, 80 and over
Canada
Community Health Services / methods*
Female
Health Behavior*
Health Promotion / methods*
Health Promotion / statistics & numerical data
Healthy Lifestyle*
Humans
Male
Middle Aged
Primary Health Care / methods*
Program Evaluation / statistics & numerical data*
Young Adult

Associated data

ClinicalTrials.gov/NCT02413385