Community hypertension prevention initiative
| ISRCTN | ISRCTN26475151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26475151 |
| Sponsor | Heart and Stroke Foundation |
| Funder | Public Health Agency of Canada |
- Submission date
- 26/11/2025
- Registration date
- 28/11/2025
- Last edited
- 28/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Plain English summary of protocol not provided at registration.
Contact information
Dr Noah Wayne
Principal investigator, Scientific, Public
Principal investigator, Scientific, Public
4700 Keele Street
Toronto
M3J 1P3
Canada
| Phone | +1 416-736-2100 |
|---|---|
| nwayne@yorku.ca |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Prevention | |
| Participant information sheet | 48570_PIS_02Feb2018.pdf | |
| Scientific title | Community hypertension prevention initiative | |
| Study acronym | Activate | |
| Study objectives | ||
| Ethics approval(s) |
Approved 01/03/2018, Community Research Ethics Office (Centre For Community Based Research, 140 Westmount Rd N, Waterloo, N2L 2S1, Canada; +1 888-411-2736; creoadmin@communityresearchethics.com), ref: 101 | |
| Health condition(s) or problem(s) studied | Prehypertension: Blood pressure greater than 120/80 and less than 139/89 | |
| Intervention | The CHPI program includes 4 phases: 1. A 20-minute intake session taking place in a pharmacy or community setting (mainly Shoppers Drug Mart and YMCA locations) and delivered by trained volunteers who are registered practical nurses. At intake locations, potential participants will be greeted by a volunteer and provided with information about the program and eligibility criteria. Individuals who meet eligibility criteria and who are interested in the program will be invited to measure their blood pressure using a validated automated measuring device, the OMRON 907XL, to determine whether they meet the second eligibility criterion for the program (i.e., being within the prehypertensive range). The meaning of their blood pressure reading, along with health implications relative to that reading, will be explained by the volunteer to all those who are screened. Qualifying participants (i.e., those being within the pre-hypertensive blood pressure range) will then be invited to enroll in the program. More specifically, with the help of a volunteer, participants will create an online account via the digital platform (NexJ Connected Wellness), wherein they will be asked to read and sign an information letter/consent form before completing a brief health questionnaire that will triage participants into high, medium or low tiers of health coaching support as well as into advanced, intermediate or beginner skill tiers of physical activity plans. Procedures will be in place to protect the privacy of participants. Upon completing enrollment, participants will receive a 2-month free trial membership to YMCA facilities. 2. A 6-month lifestyle modification intervention which combines online and offline supports for behaviour change. a. Offline interactions include access to community-based resources such as the YMCA and individualized telephone health coaching for those triaged into medium and high tiers. Health coaches will be registered allied health professionals (i.e., Kinesiologists or Physiotherapists) with advanced training in motivational interviewing and other health behavior change techniques employed by NexJ Health and the University of Ottawa Health Institute. b. Online interactions include goal setting, health information resources, tracking, prompts, a community forum, and digitized health coaching for those triaged into low tier. During the 6-month program, participants will be encouraged to track behaviours and to complete short assessments via the digital platform (NexJ Connected Wellness) to determine physical activity, diet, and smoking cessation related progress. Participants will also earn incentives, in the form of PC Optimum points, for behaviours such as attending YMCA physical activity training sessions. Medium and high tier coaching groups receive everything that Low Tier participants receive, as well as 4 and 10 phone/video chat coaching sessions respectively. 3. A 20-minute return session taking place at the same locations as intake sessions. Participants will be invited six months post their enrollment to come in for a return session; incentives in the form of PC Optimum points for attending the return session will be offered to encourage a high return rate. During the return session, participants will be assisted by a trained volunteer to: 3.1. Measure their blood pressure reading using the same validated device as used at the intake session; 3.2. Complete the same health risk assessment as at the intake session; 3.3 Complete additional questions pertaining to adoption of lifestyle changes and their overall program experience; and 3.4. Receive an updated set of recommendations for sustaining lifestyle changes based on the progress they made. 4. A follow-up survey that will be deployed 6 months following the end of the program (i.e., 12 months after the intake session). The goal of this follow-up survey will be to evaluate whether participants have maintained their behavior changes and to understand participants’ trajectory between baseline, 6-month and 12-month periods. A modified version of the health risk assessment questions used at the intake and return sessions will be asked, along with additional questions pertaining to relapses and reactivation, facilitators and barriers to behavior change maintenance, and feedback on the overall CHPI program components. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 7000 |
| Total final enrolment | 4651 |
| Key inclusion criteria | 1. Age: 18+ 2. Target blood pressure range |
| Key exclusion criteria | Active hypertension, or on hypertensive medications. |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 01/01/2020 |
Locations
Countries of recruitment
- Canada
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 28/11/2025 | No | No | ||
| Participant information sheet | 02/02/2018 | 28/11/2025 | No | Yes |
Additional files
- 48570_PIS_02Feb2018.pdf
- Participant information sheet
- 48570_Community hypertension prevention initiative briefing document.pdf
- Other files
Editorial Notes
27/11/2025: Study’s existence confirmed by the Community Research Ethics Office, Canada.
