Chronic DiseaseHeSPNCT02413385
Evidence-Based Lifestyle Prescription Program: Pilot Study
A study testing HealtheSteps Program in people with Chronic Disease and Sedentary Lifestyle, run by Western University, Canada at 1 site in Canada.
Trial summary
The HealtheSteps™ (HeS) Program is an evidence-based, community-focused, lifestyle prescription (Rx) program, supported by in-person coaching and innovative health technologies. The program improves the health of Canadians and reduces their risk for chronic disease by tackling three major risk factors that are shared… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Sedentary Lifestyle, Overweight
- What is being tested?
- HealtheSteps Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One or more self-reported or measured risk factors for chronic disease including: a) objectively-measured body-mass index of greater than or equal to 25 kg/m2; b) less than 150 minutes of exercise per week; c) greater than 3 hours of sitting per day; d) less than 8 fruit and vegetable servings per day; e) diagnosis of metabolic syndrome or type 2 diabetes
- Clear Physical Activity Readiness Questionnaire (PAR-Q) (i.e., either by answering "No" to all questions or receiving clearance from a healthcare provider)
Who cannot join
- Unable to comprehend letter of information and consent documentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canadian Diabetes Strategy Research Project - HealtheSteps™: Exercise and Healthy Eating Prescriptions to Reduce the Risk of Diabetes in Rural and Remote Communities: A Pilot Pragmatic Randomized Controlled Trial (Project 3).
The HealtheSteps™ (HeS) Program is an evidence-based, community-focused, lifestyle prescription (Rx) program, supported by in-person coaching and innovative health technologies. The program improves the health of Canadians and reduces their risk for chronic disease by tackling three major risk factors that are shared across a number of chronic diseases: physical inactivity, sedentary behaviour and poor diet. Each HeS participant receives an individualized healthy living Rx for exercise, physical activity (step counts) and healthy eating, supported by coaching and technology tools to promote long-term health behaviour change. For this study, the investigators will undertake a 6-month pilot pragmatic randomized controlled trial (RCT), conducted within 5 clinic settings in Southwestern Ontario. The primary aim is to conduct an outcome evaluation to determine the effectiveness of the HeS program in helping at-risk individuals increase physical activity levels, improve eating habits, and improve other health behaviours and health indicators.
Read the detailed description
The HealtheSteps™ (HeS) program was developed to improve the health of Canadians and reduce their risk for chronic disease (CD) and brings together emerging evidence from the areas of physical activity, nutrition, behaviour change, health technologies, and knowledge transfer, and moves knowledge into practice. HeS is an evidence-based, viable, and scalable healthy lifestyle solution to tackle the epidemic of CD in Canada. HeS goes beyond traditional health promotion messaging to give individuals a specific plan of action to improve their health and provides community settings with hands-on training, and resources from study knowledge brokers (KBs) to facilitate program uptake and sustainability. The investigators suggest that a widely available HeS program has the potential to impact the lives of Canadians at-risk for and living with CD; shift practice patterns within Family Health Teams (FHTs), Community Health Centres (CHCs) and clinics; reduce health care costs associated with CD; and inform policy decisions about health resource allocation and human resource planning. A scaled-up HeS program will offer at-risk Canadians an opportunity to actively participate in an evidence-based, community-focused, affordable (no cost to participant), healthy lifestyle program supported by point-of-care coaching and innovative electronic Health (eHealth) technologies.
This study will use a two-arm, pilot pragmatic randomized controlled trial (RCT) design. It will take place within 5 clinic settings in Southwestern Ontario. Following assessment of eligibility and baseline measurements, participants will be individually randomized (1:1; stratified by clinical setting) to either the intervention group (receiving the HeS program) or to the comparison group (usual care wait-list control). The comparison group will be offered to start the HeS program after a 6 month delay. All participants (both intervention and comparison groups) will receive publicly available healthy eating and physical activity materials at baseline. Measurements will be taken at baseline and 6 months in both groups; additional follow-up measurements will be taken in the intervention group only at 12 months and again at 18 months (from baseline). Groups will be compared at 6-months in order to examine effectiveness of the HeS program; further, follow-up to 12 and 18 months will be used to look at maintenance of any changes in the intervention group only.
- Conditions
- Chronic Disease, Sedentary Lifestyle, Overweight
- Being tested
- HealtheSteps Program
- Keywords
- lifestyle intervention, physical activity, exercise, eHealth, technology, coaching, healthy eating
- Medical subject headings
- Chronic Disease, Sedentary Behavior, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealtheSteps ProgramBehavioural
6-month evidence-based lifestyle Rx program: At set time points over the 6-month period, participants have in-person visits with a HeS coach at the clinic setting. At each in-person session, the participant receives an individualized Rx for exercise, physical activity (step count) and healthy eating. The HeS Coach and participant then engage in a coaching/goal setting conversation to set detailed plans and goals to achieve their prescriptions. Participants independently choose which activities they will take part in to achieve their lifestyle Rx's and goals. In between in-person sessions, the participants have access to a suite of free-of-charge health technology support tools to: a) track their exercise, physical activity, and healthy eating; and b) receive virtual coaching and support.
| Study group | Role | What they receive |
|---|---|---|
| HealtheSteps Program | Experimental | 6 month evidence-based lifestyle Rx program: receive lifestyle Rx's for exercise, physical activity (step counts) and healthy eating and set goals around Rx's (in person sessions at set time points during 6-month period); take part in self-directed healthy living activities to achieve Rx's (Months 0-6); access to a suite of health technology support options for additional support and coaching (Months 0-6). Receives: Behavioral: HealtheSteps Program |
| Usual-care wait-list control | No intervention | No active intervention (usual care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average steps per day
Measured over 7-day monitoring period using pedometers (Yamax Digiwalker SW200 model)
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Secondary outcomes (12)
Total physical activity (metabolic equivalent (MET)-minutes/week)
From the International Physical Activity Questionnaire - Short Version
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Time spent in sedentary activity (minutes/day)
From the International Physical Activity Questionnaire - Short Version
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Eating habits: Total healthful eating score
Measured by Starting the conversation questionnaire
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Eating habits: Fruit and vegetable consumption
Measured by the modified Dietary Instrument for Nutrition Education questionnaire
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Eating habits: Fatty food score
Measured by the modified Dietary Instrument for Nutrition Education questionnaire
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Eating habits: sugary food consumption
Measured by the modified Dietary Instrument for Nutrition Education questionnaire
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Health-related quality of life: self-rated health
Visual Analogue Scale score measured using questionnaire known as EQ-5D-3L
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Resting systolic blood pressure
Measured using automated blood pressure monitor
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Resting diastolic blood pressure
Measured using automated blood pressure monitor
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Weight loss (absolute and percentage)
Measured using digital weight scale
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Waist circumference
Measured using tape measure
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Body mass index
Calculated from height (stadiometer) and weight (digital weight scale) measurements
Measured: 6 months (plus 12 and 18 months in the intervention group only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Robert Petrella, Western University, Canada
- Investigators
- Robert J Petrella, MD, PhD, Principal investigator, University of Western Ontario, Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413385
- Sponsor's protocol ID
- HealtheSteps3
- Acronym
- HeSP
- Status last verified
- Sep 2017
- First submitted
- 6 Apr 2015
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Petrella RJ, Koval JJ, Cunningham DA, Paterson DH. Can primary care doctors prescribe exercise to improve fitness? The Step Test Exercise Prescription (STEP) project. Am J Prev Med. 2003 May;24(4):316-22. doi: 10.1016/s0749-3797(03)00022-9.
PubMed 12726869Petrella RJ, Lattanzio CN, Demeray A, Varallo V, Blore R. Can adoption of regular exercise later in life prevent metabolic risk for cardiovascular disease? Diabetes Care. 2005 Mar;28(3):694-701. doi: 10.2337/diacare.28.3.694.
PubMed 15735210Petrella RJ, Lattanzio CN, Overend TJ. Physical activity counseling and prescription among canadian primary care physicians. Arch Intern Med. 2007 Sep 10;167(16):1774-81. doi: 10.1001/archinte.167.16.1774.
PubMed 17846397Petrella RJ, Lattanzio CN, Shapiro S, Overend T. Improving aerobic fitness in older adults: effects of a physician-based exercise counseling and prescription program. Can Fam Physician. 2010 May;56(5):e191-200.
PubMed 20463260Petrella RJ, Aizawa K, Shoemaker K, Overend T, Piche L, Marin M, Shapiro S, Atkin S. Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC): study protocol for a randomized controlled trial. Trials. 2011 Feb 16;12:45. doi: 10.1186/1745-6215-12-45.
PubMed 21324150Stuckey M, Fulkerson R, Read E, Russell-Minda E, Munoz C, Kleinstiver P, Petrella R. Remote monitoring technologies for the prevention of metabolic syndrome: the Diabetes and Technology for Increased Activity (DaTA) study. J Diabetes Sci Technol. 2011 Jul 1;5(4):936-44. doi: 10.1177/193229681100500417.
PubMed 21880237Stuckey M, Russell-Minda E, Read E, Munoz C, Shoemaker K, Kleinstiver P, Petrella R. Diabetes and Technology for Increased Activity (DaTA) study: results of a remote monitoring intervention for prevention of metabolic syndrome. J Diabetes Sci Technol. 2011 Jul 1;5(4):928-35. doi: 10.1177/193229681100500416.
PubMed 21880236Noble E, Melling J, Shoemaker K, Tikkanen H, Peltonen J, Stuckey M, Petrella RJ. Innovation to reduce cardiovascular complications of diabetes at the intersection of discovery, prevention and knowledge exchange. Can J Diabetes. 2013 Oct;37(5):282-93. doi: 10.1016/j.jcjd.2013.07.061.
PubMed 24500553Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implement Sci. 2008 Jan 7;3:1. doi: 10.1186/1748-5908-3-1.
PubMed 18179688Rycroft-Malone J, Harvey G, Kitson A, McCormack B, Seers K, Titchen A. Getting evidence into practice: ingredients for change. Nurs Stand. 2002 May 29-Jun 4;16(37):38-43. doi: 10.7748/ns2002.05.16.37.38.c3201.
PubMed 12068568Ward V, House A, Hamer S. Knowledge Brokering: The missing link in the evidence to action chain? Evid Policy. 2009 Aug;5(3):267-279. doi: 10.1332/174426409X463811.
PubMed 21258626Gill DP, Blunt W, Boa Sorte Silva NC, Stiller-Moldovan C, Zou GY, Petrella RJ. The HealtheSteps lifestyle prescription program to improve physical activity and modifiable risk factors for chronic disease: a pragmatic randomized controlled trial. BMC Public Health. 2019 Jun 28;19(1):841. doi: 10.1186/s12889-019-7141-2.
PubMed 31253112Gill DP, Blunt W, Bartol C, Pulford RW, De Cruz A, Simmavong PK, Gavarkovs A, Newhouse I, Pearson E, Ostenfeldt B, Law B, Karvinen K, Moffit P, Jones G, Watson C, Zou G, Petrella RJ. 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.
PubMed 28173782
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Diabetes Strategy Research Project - HealtheSteps™: Exercise and Healthy Eating Prescriptions to Reduce the Risk of Diabetes in Rural and Remote Communities: A Pilot Pragmatic Randomized Controlled Trial (Project 3).
- ClinicalTrials.gov ID
- NCT02413385
- Acronym / sponsor ID
- HeSP / HealtheSteps3
- Conditions
- Chronic Disease, Sedentary Lifestyle, Overweight
- Keywords
- lifestyle intervention, physical activity, exercise, eHealth, technology, coaching, healthy eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The HealtheSteps™ (HeS) Program is an evidence-based, community-focused, lifestyle prescription (Rx) program, supported by in-person coaching and innovative health technologies. The program improves the health of Canadians and reduces their risk for chronic disease by tackling three major risk factors that are shared across a number of chronic diseases: physical inactivity, sedentary behaviour and poor diet. Each HeS participant receives an individualized healthy living Rx for exercise, physical activity (step counts) and healthy eating, supported by coaching and technology tools to promote long-term health behaviour change. For this study, the investigators will undertake a 6-month pilot pragmatic randomized controlled trial (RCT), conducted within 5 clinic settings in Southwestern Ontario. The primary aim is to conduct an outcome evaluation to determine the effectiveness of the HeS program in helping at-risk individuals increase physical activity levels, improve eating habits, and improve other health behaviours and health indicators.
Detailed description
The HealtheSteps™ (HeS) program was developed to improve the health of Canadians and reduce their risk for chronic disease (CD) and brings together emerging evidence from the areas of physical activity, nutrition, behaviour change, health technologies, and knowledge transfer, and moves knowledge into practice. HeS is an evidence-based, viable, and scalable healthy lifestyle solution to tackle the epidemic of CD in Canada. HeS goes beyond traditional health promotion messaging to give individuals a specific plan of action to improve their health and provides community settings with hands-on training, and resources from study knowledge brokers (KBs) to facilitate program uptake and sustainability. The investigators suggest that a widely available HeS program has the potential to impact the lives of Canadians at-risk for and living with CD; shift practice patterns within Family Health Teams (FHTs), Community Health Centres (CHCs) and clinics; reduce health care costs associated with CD; and inform policy decisions about health resource allocation and human resource planning. A scaled-up HeS program will offer at-risk Canadians an opportunity to actively participate in an evidence-based, community-focused, affordable (no cost to participant), healthy lifestyle program supported by point-of-care coaching and innovative electronic Health (eHealth) technologies.
This study will use a two-arm, pilot pragmatic randomized controlled trial (RCT) design. It will take place within 5 clinic settings in Southwestern Ontario. Following assessment of eligibility and baseline measurements, participants will be individually randomized (1:1; stratified by clinical setting) to either the intervention group (receiving the HeS program) or to the comparison group (usual care wait-list control). The comparison group will be offered to start the HeS program after a 6 month delay. All participants (both intervention and comparison groups) will receive publicly available healthy eating and physical activity materials at baseline. Measurements will be taken at baseline and 6 months in both groups; additional follow-up measurements will be taken in the intervention group only at 12 months and again at 18 months (from baseline). Groups will be compared at 6-months in order to examine effectiveness of the HeS program; further, follow-up to 12 and 18 months will be used to look at maintenance of any changes in the intervention group only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HealtheSteps Program | Experimental | Behavioral: HealtheSteps Program6 month evidence-based lifestyle Rx program: receive lifestyle Rx's for exercise, physical activity (step counts) and healthy eating and set goals around Rx's (in person sessions at set time points during 6-month period); take part in self-directed healthy living activities to achieve Rx's (Months 0-6); access to a suite of health technology support options for additional support and coaching (Months 0-6). |
| Usual-care wait-list control | No intervention | –No active intervention (usual care). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- One or more self-reported or measured risk factors for chronic disease including: a) objectively-measured body-mass index of greater than or equal to 25 kg/m2; b) less than 150 minutes of exercise per week; c) greater than 3 hours of sitting per day; d) less than 8 fruit and vegetable servings per day; e) diagnosis of metabolic syndrome or type 2 diabetes
- Clear Physical Activity Readiness Questionnaire (PAR-Q) (i.e., either by answering "No" to all questions or receiving clearance from a healthcare provider)
Key exclusion criteria (1 listed)
- Unable to comprehend letter of information and consent documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealtheSteps Program6-month evidence-based lifestyle Rx program: At set time points over the 6-month period, participants have in-person visits with a HeS coach at the clinic setting. At each in-person session, the participant receives an individualized Rx for exercise, physical activity (step count) and healthy eating. The HeS Coach and participant then engage in a coaching/goal setting conversation to set detailed plans and goals to achieve their prescriptions. Participants independently choose which activities they will take part in to achieve their lifestyle Rx's and goals. In between in-person sessions, the participants have access to a suite of free-of-charge health technology support tools to: a) track their exercise, physical activity, and healthy eating; and b) receive virtual coaching and support. | Behavioural | HealtheSteps Program |
Primary outcome
Average steps per day
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Measured over 7-day monitoring period using pedometers (Yamax Digiwalker SW200 model)
12 secondary outcomes
Total physical activity (metabolic equivalent (MET)-minutes/week)
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Time spent in sedentary activity (minutes/day)
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Eating habits: Total healthful eating score
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Eating habits: Fruit and vegetable consumption
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Eating habits: Fatty food score
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Eating habits: sugary food consumption
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Health-related quality of life: self-rated health
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Resting systolic blood pressure
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Resting diastolic blood pressure
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Weight loss (absolute and percentage)
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Waist circumference
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Body mass index
Time frame: 6 months (plus 12 and 18 months in the intervention group only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Background: PubMed 12726869Petrella RJ, Koval JJ, Cunningham DA, Paterson DH. Can primary care doctors prescribe exercise to improve fitness? The Step Test Exercise Prescription (STEP) project. Am J Prev Med. 2003 May;24(4):316-22. doi: 10.1016/s0749-3797(03)00022-9.
- Background: PubMed 15735210Petrella RJ, Lattanzio CN, Demeray A, Varallo V, Blore R. Can adoption of regular exercise later in life prevent metabolic risk for cardiovascular disease? Diabetes Care. 2005 Mar;28(3):694-701. doi: 10.2337/diacare.28.3.694.
- Background: PubMed 17846397Petrella RJ, Lattanzio CN, Overend TJ. Physical activity counseling and prescription among canadian primary care physicians. Arch Intern Med. 2007 Sep 10;167(16):1774-81. doi: 10.1001/archinte.167.16.1774.
- Background: PubMed 20463260Petrella RJ, Lattanzio CN, Shapiro S, Overend T. Improving aerobic fitness in older adults: effects of a physician-based exercise counseling and prescription program. Can Fam Physician. 2010 May;56(5):e191-200.
- Background: PubMed 21324150Petrella RJ, Aizawa K, Shoemaker K, Overend T, Piche L, Marin M, Shapiro S, Atkin S. Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC): study protocol for a randomized controlled trial. Trials. 2011 Feb 16;12:45. doi: 10.1186/1745-6215-12-45.
- Background: PubMed 21880237Stuckey M, Fulkerson R, Read E, Russell-Minda E, Munoz C, Kleinstiver P, Petrella R. Remote monitoring technologies for the prevention of metabolic syndrome: the Diabetes and Technology for Increased Activity (DaTA) study. J Diabetes Sci Technol. 2011 Jul 1;5(4):936-44. doi: 10.1177/193229681100500417.
- Background: PubMed 21880236Stuckey M, Russell-Minda E, Read E, Munoz C, Shoemaker K, Kleinstiver P, Petrella R. Diabetes and Technology for Increased Activity (DaTA) study: results of a remote monitoring intervention for prevention of metabolic syndrome. J Diabetes Sci Technol. 2011 Jul 1;5(4):928-35. doi: 10.1177/193229681100500416.
- Background: PubMed 24500553Noble E, Melling J, Shoemaker K, Tikkanen H, Peltonen J, Stuckey M, Petrella RJ. Innovation to reduce cardiovascular complications of diabetes at the intersection of discovery, prevention and knowledge exchange. Can J Diabetes. 2013 Oct;37(5):282-93. doi: 10.1016/j.jcjd.2013.07.061.
- Background: PubMed 18179688Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implement Sci. 2008 Jan 7;3:1. doi: 10.1186/1748-5908-3-1.
- Background: PubMed 12068568Rycroft-Malone J, Harvey G, Kitson A, McCormack B, Seers K, Titchen A. Getting evidence into practice: ingredients for change. Nurs Stand. 2002 May 29-Jun 4;16(37):38-43. doi: 10.7748/ns2002.05.16.37.38.c3201.
- Background: PubMed 21258626Ward V, House A, Hamer S. Knowledge Brokering: The missing link in the evidence to action chain? Evid Policy. 2009 Aug;5(3):267-279. doi: 10.1332/174426409X463811.
- Derived from this study: PubMed 31253112Gill DP, Blunt W, Boa Sorte Silva NC, Stiller-Moldovan C, Zou GY, Petrella RJ. The HealtheSteps lifestyle prescription program to improve physical activity and modifiable risk factors for chronic disease: a pragmatic randomized controlled trial. BMC Public Health. 2019 Jun 28;19(1):841. doi: 10.1186/s12889-019-7141-2.
- Improving the health of Canadians with evidence-based lifestyle prescriptions websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Petrella, MD, PhD principal investigator
University of Western Ontario, Lawson Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealtheSteps Program in people with Chronic Disease and Sedentary Lifestyle, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average steps per day (time frame: 6 months (plus 12 and 18 months in the intervention group only)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02413385, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.