Chronic DiseaseNCT04746859
Evaluation of the Effectiveness and Implementation of the BETTER Women Peer Health Coaching Program
A study testing Prevention Visit and Peer health coaching in people with Chronic Disease and Cancer, run by Women's College Hospital at 3 sites in Canada.
Trial summary
The Building on Existing Tools To improvE cancer and chronic disease pRevention and screening in primary care (BETTER) Program allows patients in primary care to have a dedicated visit with a prevention practitioner to discuss chronic disease prevention and cancer screening. Read more about this study
- Who is it for?
- Ages 40 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Cancer
- What is being tested?
- Prevention Visit and Peer health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 3 sitesCanada
- Study dates
- 14 Jun 2021to 1 Apr 2025
- 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 40 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient identifies as a woman;
- Patient is 40-68yo;
- Patient has an email address;
- Patient has at least one behavioural risk factor not at target or at least one cancer screening overdue as defined below:
- Score of less than 9 on the Mediterranean Diet Tool
- Less than 150 minutes of moderate to vigorous physical activity per week
Show all 11Show fewer
- Smoked a cigarette within the last 30 days
- Average number of drinks per day is ≥1 and/or has >1 drink on any single occasion
- Due or overdue for one or more of breast, cervical or colorectal cancer screenings;
- Patient has a valid number for the provincial health insurance program (Ontario Health Insurance Program [OHIP]); and
- Patient's medical records for, at least the previous 3 years are accessible through their family physician.
Who cannot join
- Patient is unable to give informed consent in English due to language, literacy, or competence;
- Patient is unable or unwilling to communicate with the study team to collect outcomes in English via both email and phone; or
- Patient's primary care provider has identified medical comorbidities or other conditions at baseline that might interfere with the patient's ability to follow through on the intervention.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Barrie and Community Family Health Team
Barrie, Ontario, L4N 7L3
Summerville Family Health Team
Mississauga, Ontario, L5B 2P7
Women's College Hospital Family Practice Health Centre
Toronto, Ontario, M5S 1B3
About this study
Official title: BETTER Women: Community-Based, Primary Care-Linked Peer Health Coaching to Achieve Evidence-Based Preventive Care Goals - A Pragmatic, Wait-List Controlled Effectiveness-Implementation Trial
The Building on Existing Tools To improvE cancer and chronic disease pRevention and screening in primary care (BETTER) Program allows patients in primary care to have a dedicated visit with a prevention practitioner to discuss chronic disease prevention and cancer screening. A prevention practitioner is a health professional, working in primary care, who has received additional training to discuss chronic disease prevention and screening and develop health goals with patients through shared decision-making. Previous studies have shown that this approach increases the number of prevention and screening actions completed by program participants. However, maintenance of health behaviour changes is difficult without on-going support. There is also some evidence that peer-delivered coaching can improve health outcomes in community settings. As such, the BETTER Women program extends the BETTER program by focusing on 40 to 68-year-old women and providing time-limited support for health behaviour change through peer health coaches. Coaches are volunteers - trained in techniques to support health behaviour change - who support women to achieve their health goals over a 6-month period. In this study, the investigators will explore: (i) whether patients who participate in health coaching after a prevention visit are more likely to increase the number of prevention and screening actions that they complete after six months, compared to women who participate in a prevention visit but do not get health coaching; (ii) whether the intervention effects endure six months after the intervention ends; and (iii) the implementation of the program to learn about factors that affect various aspects of the success and sustainability of the program.
Read the detailed description
While the BETTER program has been shown to successfully increase the number of preventive care and screening actions completed by patient participants after six months, it is known that it is difficult to maintain new health behaviours in the long-term. Unfortunately, it is not feasible to fund health professionals to offer repeated follow-up visits over the time needed to turn initial behaviour changes into long-term habits. Therefore, the investigators are building upon the existing BETTER program by adding a peer health coaching extension that will provide time-limited coaching for patients who want support as they work towards achieving preventive health goals. This approach takes advantage of growing awareness of the role of lay health coaches in improving and extending the quality and value of primary care.
This is a three-site, pragmatic, wait-list-controlled, randomized, Type 1 hybrid effectiveness-implementation trial with blinded outcome collection after 6 months. One site will be an urban, academic, hospital-based clinic; the second will be a clinic serving a greater proportion of patients from rural areas; and the third site will be a suburban clinic with a large South Asian population. Investigators will invite women who are 40-68 years old to have a single visit with a prevention practitioner and receive behaviour change support for up to six months from a health coach. Coaches will do a 24-hr training course, which includes special techniques to support health behaviour change, before they are matched to a patient. At the suburban site, only South Asian peer health coaches will be recruited and this work is being guided by a South Asian Community Advisory Council made up of members of various community organizations in that region. Patients who enroll in BETTER Women will be randomized to receive health coaching either immediately (intervention group) or after a 6-month delay (wait-list control group).
Effectiveness of the program will be assessed by evaluating for each patient, how many of a set of target chronic disease prevention and screening actions were completed at six months, in comparison to baseline. Investigators will also assess whether patients achieved the health goals that they set with their prevention practitioners, physiological markers of health, as well as habits and behaviours related to diet, physical activity, smoking and alcohol use. These outcomes will be collected via electronic surveys administered at baseline, 3- and 6-months* post enrollment as well as through extraction of data from the patients' electronic medical records and BETTER program documents. These outcomes will be compared between the two groups of patients in the study. Additionally, investigators will survey intervention group participants and extract relevant data from their electronic medical records at 12-months* post enrollment.
An embedded process evaluation will be conducted during the trial to examine the implementation of the program. The process evaluation will include collection of program data, electronic surveys administered to patients as well as qualitative interviews with intervention group patients, peer health coaches and prevention practitioners. Investigators will examine how acceptable the program was to patients; whether and why any adaptations were made; how well the program was utilized; how well the coaches delivered the intervention (e.g., what behaviour change techniques were used); how engaged patients and coaches were with the program; and mechanism(s) of action. Ultimately, investigators expect to gain an understanding of the program's sustainability, acceptability, cost-effectiveness, and factors that might impact future attempts at spread and scale.
Investigators expect to see that women in the intervention group (i.e., those who had a health coach) will complete more preventive and screening actions after six months. Investigators also expect to see that women in the intervention group will make more progress on achieving health goals and making lifestyle changes which reduce the risk of chronic diseases and cancers, that the intervention will increase women's access to resources in their primary care clinics and community, as well as improve the women's ability to maintain healthy behaviours.
Note*: The investigators initially planned to collect surveys and data for the primary outcome (for both groups) at 12 months post enrollment. However, due to pandemic-related recruitment challenges, the data collection timeline was amended as described above to allow more time for recruitment within the project timeline.
- Conditions
- Chronic Disease, Cancer
- Being tested
- Prevention Visit, Peer health coaching
- Keywords
- chronic disease prevention, cancer screening, community health worker, family practice, randomized control trial, hybrid design, process evaluation
- Medical subject headings
- Chronic Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention VisitOther
Patients will have a one-on-one, approximately one-hour long visit with a specially trained Prevention Practitioner. During this visit, they will discuss the patient's health history, their risks for developing chronic diseases, including cancer, and possible steps they can take to reduce those risks. The Prevention Practitioner will also assist the patient to develop and articulate specific goals the patient would like to work on to reduce their risk of chronic diseases.
Peer health coachingBehavioural
Patients will be invited to register with the software platform used to facilitate peer health coaching. Once they have registered, they will be matched to a peer health coach who will connect with the patient to initiate the process. The coach will work collaboratively with the patient to help her follow through on a step-wise, personalized plan to achieve health goals that were developed with their prevention practitioner. The coach's approach will be informed by principles of brief action planning and motivational interviewing. Coaches will also provide social support, help to navigate to relevant information and community resources, and advise about options for self-monitoring. Coaching will occur over 12-16 sessions via phone calls, text messages, video calls and/or in-person meetings as desired/convenient and in accordance with local public health guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will have a prevention visit with a Prevention Practitioner (a healthcare provider who has received additional training), complete the baseline survey then be invited to receive ongoing support from a trained, volunteer peer health coach, for up to six months. The coach will support the patient as she works towards achieving personalized health goals to reduce her risk of chronic diseases, including cancer. Patients will be administered additional surveys at 3 and 6 months and a final survey at 12 months. Receives: Other: Prevention Visit; Behavioral: Peer health coaching |
| Wait-list Control | Other | Patients will have a prevention visit with a Prevention Practitioner (a healthcare provider who has received additional training) and complete a baseline survey, after which they will receive usual care from their healthcare providers. Patients will be administered another survey at 3 months and a final survey at 6 months. After study completion (about 6-months after the initial prevention visit), patients will be invited to receive ongoing support from a trained, volunteer peer health coach, for up to six months. The coach will support the patient as she works towards achieving personalized health goals to reduce her risk of chronic diseases, including cancer. Receives: Other: Prevention Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased targeted behaviours from baseline
The primary outcome is binary and defined as whether a patient increased the number of completed targeted behaviours from baseline to end of follow-up at 6 months. The targeted behaviours include the status (up to date or out of date) of three cancer screening tests (cervical, breast, colorectal) and the status (meeting evidence-based target or not) of four behavioural determinants for risk of cancer and chronic disease (diet, smoking, alcohol use, physical activity). If a patient meets at least one more target at 6 months than they met at baseline, their outcome will be considered positive.
Measured: 0, 6 months
Secondary outcomes (32)
Goal achievement
Percentage of patient-set health goals that was achieved
Measured: 0, 6 months; 12 months for intervention group only
Breast cancer screening status
Binary assessment of whether the patient is up to date on their breast cancer screening, as per their history and level of risk
Measured: 0, 6 months
Cervical cancer screening status
Binary assessment of whether the patient is up to date on their cervical cancer screening, as per their history and level of risk
Measured: 0, 6 months
Colorectal cancer screening status
Binary assessment of whether the patient is up to date on their colorectal cancer screening, as per their history and level of risk
Measured: 0, 6 months
Diet status
Binary assessment of whether the patient's Mediterranean Diet Score is at target (≥9)
Measured: 0, 3, 6 months; 12 months for intervention group only
Improvement in diet
Binary assessment of whether there was an evidence-based improvement (change ≥2) in diet between assessment points
Measured: 0, 3, 6 months; 12 months for intervention group only
Diet management
Binary assessment of whether patient took at least one meaningful action towards diet management
Measured: 0, 3, 6 months; 12 months for intervention group only
Physical activity status
Binary assessment of whether time (in minutes) spent doing moderate to vigorous physical activity in the last seven days is at the evidence-based target (≥150minutes)
Measured: 0, 3, 6 months; 12 months for intervention group only
Improvement in physical activity
Binary assessment of whether or not there was improvement in the physical activity index (PAI) between assessment points
Measured: 0, 3, 6 months; 12 months for intervention group only
Physical activity management
Binary assessment of whether patient took at least one meaningful action towards physical activity management
Measured: 0, 3, 6 months; 12 months for intervention group only
Smoking status
Binary assessment of whether smoking status meets the target of abstinent for the last 30 days
Measured: 0, 3, 6 months; 12 months for intervention group only
Improvement in smoking
Binary assessment of whether the patient's cigarette consumption category, based on consumption of cigarettes per day (cpd), has improved (i.e., cpd decreased) between assessment points
Measured: 0, 3, 6 months; 12 months for intervention group only
Smoking management
Binary assessment of whether patient took at least one meaningful action towards management of smoking behaviour
Measured: 0, 3, 6 months; 12 months for intervention group only
Alcohol use status
Binary assessment of whether alcohol use is at evidence-based target, i.e., number of drinks per day is <1 and never having ≥1 drink on one occasion
Measured: 0, 3, 6 months; 12 months for intervention group only
Improvement in alcohol use
Binary assessment of whether AUDIT risk category has improved (i.e., risk level has decreased) between assessment points
Measured: 0, 3, 6 months; 12 months for intervention group only
Alcohol use management
Binary assessment of whether patient took at least one meaningful action towards management of alcohol use
Measured: 0, 3, 6 months; 12 months for intervention group only
Up-to-date measurement of glycated haemoglobin (HbA1c)
Binary assessment of whether the latest HbA1c measurement is up to date at study end, as per patient's characteristics
Measured: 0, 6 months; 12 months for intervention group only
HbA1c control
Binary assessment of whether the latest measurement, at study end, is up to date and at target (<7%)
Measured: 0, 6 months; 12 months for intervention group only
HbA1c
The most recent and up to date HbA1c measurement for patients with diabetes mellitus (DM)
Measured: 0, 6 months; 12 months for intervention group only
Glycemic management
Binary assessment of whether patient with DM (HbA1c not at target) has taken any meaningful actions towards management of blood sugar through initiation of new antihyperglycemic medication, up-titration of existing antihyperglycemic medications, or discussion with healthcare professional regarding behavioural changes needed to improve blood sugar
Measured: 0, 3, 6 months; 12 months for intervention group only
Up-to-date measurement of blood pressure (BP)
Binary assessment of whether the latest BP measurement is up to date, as per patient's characteristics
Measured: 0, 6 months; 12 months for intervention group only
BP control
Binary assessment of whether the most recent measurement is up to date and at target as per patient's characteristics
Measured: 0, 6 months; 12 months for intervention group only
Systolic BP
The most recent and up to date systolic BP measurement
Measured: 0, 6 months; 12 months for intervention group only
Diastolic BP
The most recent and up to date diastolic BP measurement
Measured: 0, 6 months; 12 months for intervention group only
Hypertension management
Binary assessment of whether patient with BP not at target has taken at least one action towards management of hypertension through initiation of new blood pressure medication, up-titration of existing blood pressure medication, or discussion with healthcare professional regarding behavioural changes needed to improve blood pressure
Measured: 0, 3, 6 months; 12 months for intervention group only
Up-to-date assessment of low-density lipoprotein (LDL) cholesterol
Binary assessment of whether the latest LDL measurement is up to date, as per patient's characteristics
Measured: 0, 6 months; 12 months for intervention group only
LDL control
Binary assessment of whether the most recent LDL measurement is up to date and at target as per patient's characteristics
Measured: 0, 6 months; 12 months for intervention group only
LDL
The most recent and up to date LDL measurement
Measured: 0, 6 months; 12 months for intervention group only
LDL cholesterol management
Binary assessment of whether patient with LDL not at target has taken at least one action towards management of LDL through initiation of new LDL medication, up-titration of existing LDL medication, or discussion with healthcare professional regarding behavioural changes needed to improve cholesterol
Measured: 0, 3, 6 months; 12 months for intervention group only
Up-to-date assessment for obesity
Binary assessment of whether body mass index (BMI) calculation or waist circumference (WC) measurement is up to date, as per patient's characteristics
Measured: 0, 6 months; 12 months for intervention group only
BMI control
Binary assessment of whether latest, up to date BMI is within target (≤ 30kg/m2)
Measured: 0, 6 months; 12 months for intervention group only
Management of obesity
Binary assessment of whether patient with BMI not at target took any meaningful actions towards management of obesity through use of medication or discussion with healthcare professional regarding behavioural changes needed to manage obesity
Measured: 0, 3, 6 months; 12 months for 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 posted10 Feb 2021
- Study start14 Jun 2021
- Primary completion23 Oct 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), Public Health Agency of Canada (PHAC), Women's College Hospital Foundation, Women's College Hospital Family Practice Health Centre, Barrie and Community Family Health Team, University Health Network, Toronto, Applied Health Research Centre, Summerville Family Health Team
- Responsible party
- Principal investigator, Noah Ivers, Women's College Hospital
- Investigators
- Noah M Ivers, MD, PhD, Principal investigator, Women's College HospitalAisha Lofters, MD, PhD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746859
- Sponsor's protocol ID
- 2020-0079-E
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be available for analysis. Data will be shared through secure platforms compliant with PHIPA. Researchers must submit a data access request, including their research proposal, analysis plan, and research ethics board approval. Types of Data Available: Baseline and follow-up (3-, 6-, and 12-month) surveys, BETTER Health Survey, Prevention Prescription and Goals, and relevant outcomes from electronic medical records. Other Available Documents: Protocol, Survey Instruments, Interview guides Applicable Analyses: Health outcomes and behavior change; Economic evaluations; Implementation and process evaluations; Exploratory analyses on effect modifiers and mechanisms of action; Comparative studies on intervention efficacy Privacy and Confidentiality: All data will be de-identified to protect participant privacy. Data transfer and storage will comply with PHIPA. Data will be securely stored in a database with access limited to authorized personnel.
Publications
Grunfeld E, Manca D, Moineddin R, Thorpe KE, Hoch JS, Campbell-Scherer D, Meaney C, Rogers J, Beca J, Krueger P, Mamdani M; BETTER Trial Investigators. Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial. BMC Fam Pract. 2013 Nov 20;14:175. doi: 10.1186/1471-2296-14-175.
PubMed 24252125Bodenheimer TS, Smith MD. Primary care: proposed solutions to the physician shortage without training more physicians. Health Aff (Millwood). 2013 Nov;32(11):1881-6. doi: 10.1377/hlthaff.2013.0234.
PubMed 24191075Kithulegoda N, Williams C, Senthilmurugan A, Aimola S, Atkinson J, Banerjee AT, Bazeghi F, Bender JL, Flynn S, Ghatage L, Goulbourne E, Grunfeld E, Heisey R, Rao A, Sutcliffe K, Lofters A, Ivers NM. Assessing the effectiveness of "BETTER Women", a community-based, primary care-linked peer health coaching programme for chronic disease prevention: protocol for a pragmatic, wait-list controlled, type 1 hybrid effectiveness-implementation trial. BMJ Open. 2024 Jul 24;14(7):e085933. doi: 10.1136/bmjopen-2024-085933.
PubMed 39053957
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BETTER Women: Community-Based, Primary Care-Linked Peer Health Coaching to Achieve Evidence-Based Preventive Care Goals - A Pragmatic, Wait-List Controlled Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT04746859
- Acronym / sponsor ID
- 2020-0079-E
- Conditions
- Chronic Disease, Cancer
- Keywords
- chronic disease prevention, cancer screening, community health worker, family practice, randomized control trial, hybrid design, process evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), Public Health Agency of Canada (PHAC), Women's College Hospital Foundation, Women's College Hospital Family Practice Health Centre, Barrie and Community Family Health Team, University Health Network, Toronto, Applied Health Research Centre, Summerville Family Health Team
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 10 Feb 2021 (actual)
- 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 Building on Existing Tools To improvE cancer and chronic disease pRevention and screening in primary care (BETTER) Program allows patients in primary care to have a dedicated visit with a prevention practitioner to discuss chronic disease prevention and cancer screening. A prevention practitioner is a health professional, working in primary care, who has received additional training to discuss chronic disease prevention and screening and develop health goals with patients through shared decision-making. Previous studies have shown that this approach increases the number of prevention and screening actions completed by program participants. However, maintenance of health behaviour changes is difficult without on-going support. There is also some evidence that peer-delivered coaching can improve health outcomes in community settings. As such, the BETTER Women program extends the BETTER program by focusing on 40 to 68-year-old women and providing time-limited support for health behaviour change through peer health coaches. Coaches are volunteers - trained in techniques to support health behaviour change - who support women to achieve their health goals over a 6-month period. In this study, the investigators will explore: (i) whether patients who participate in health coaching after a prevention visit are more likely to increase the number of prevention and screening actions that they complete after six months, compared to women who participate in a prevention visit but do not get health coaching; (ii) whether the intervention effects endure six months after the intervention ends; and (iii) the implementation of the program to learn about factors that affect various aspects of the success and sustainability of the program.
Detailed description
While the BETTER program has been shown to successfully increase the number of preventive care and screening actions completed by patient participants after six months, it is known that it is difficult to maintain new health behaviours in the long-term. Unfortunately, it is not feasible to fund health professionals to offer repeated follow-up visits over the time needed to turn initial behaviour changes into long-term habits. Therefore, the investigators are building upon the existing BETTER program by adding a peer health coaching extension that will provide time-limited coaching for patients who want support as they work towards achieving preventive health goals. This approach takes advantage of growing awareness of the role of lay health coaches in improving and extending the quality and value of primary care.
This is a three-site, pragmatic, wait-list-controlled, randomized, Type 1 hybrid effectiveness-implementation trial with blinded outcome collection after 6 months. One site will be an urban, academic, hospital-based clinic; the second will be a clinic serving a greater proportion of patients from rural areas; and the third site will be a suburban clinic with a large South Asian population. Investigators will invite women who are 40-68 years old to have a single visit with a prevention practitioner and receive behaviour change support for up to six months from a health coach. Coaches will do a 24-hr training course, which includes special techniques to support health behaviour change, before they are matched to a patient. At the suburban site, only South Asian peer health coaches will be recruited and this work is being guided by a South Asian Community Advisory Council made up of members of various community organizations in that region. Patients who enroll in BETTER Women will be randomized to receive health coaching either immediately (intervention group) or after a 6-month delay (wait-list control group).
Effectiveness of the program will be assessed by evaluating for each patient, how many of a set of target chronic disease prevention and screening actions were completed at six months, in comparison to baseline. Investigators will also assess whether patients achieved the health goals that they set with their prevention practitioners, physiological markers of health, as well as habits and behaviours related to diet, physical activity, smoking and alcohol use. These outcomes will be collected via electronic surveys administered at baseline, 3- and 6-months* post enrollment as well as through extraction of data from the patients' electronic medical records and BETTER program documents. These outcomes will be compared between the two groups of patients in the study. Additionally, investigators will survey intervention group participants and extract relevant data from their electronic medical records at 12-months* post enrollment.
An embedded process evaluation will be conducted during the trial to examine the implementation of the program. The process evaluation will include collection of program data, electronic surveys administered to patients as well as qualitative interviews with intervention group patients, peer health coaches and prevention practitioners. Investigators will examine how acceptable the program was to patients; whether and why any adaptations were made; how well the program was utilized; how well the coaches delivered the intervention (e.g., what behaviour change techniques were used); how engaged patients and coaches were with the program; and mechanism(s) of action. Ultimately, investigators expect to gain an understanding of the program's sustainability, acceptability, cost-effectiveness, and factors that might impact future attempts at spread and scale.
Investigators expect to see that women in the intervention group (i.e., those who had a health coach) will complete more preventive and screening actions after six months. Investigators also expect to see that women in the intervention group will make more progress on achieving health goals and making lifestyle changes which reduce the risk of chronic diseases and cancers, that the intervention will increase women's access to resources in their primary care clinics and community, as well as improve the women's ability to maintain healthy behaviours.
Note*: The investigators initially planned to collect surveys and data for the primary outcome (for both groups) at 12 months post enrollment. However, due to pandemic-related recruitment challenges, the data collection timeline was amended as described above to allow more time for recruitment within the project timeline.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Prevention Visit, Behavioral: Peer health coachingPatients will have a prevention visit with a Prevention Practitioner (a healthcare provider who has received additional training), complete the baseline survey then be invited to receive ongoing support from a trained, volunteer peer health coach, for up to six months. The coach will support the patient as she works towards achieving personalized health goals to reduce her risk of chronic diseases, including cancer. Patients will be administered additional surveys at 3 and 6 months and a final survey at 12 months. |
| Wait-list Control | Other | Other: Prevention VisitPatients will have a prevention visit with a Prevention Practitioner (a healthcare provider who has received additional training) and complete a baseline survey, after which they will receive usual care from their healthcare providers. Patients will be administered another survey at 3 months and a final survey at 6 months. After study completion (about 6-months after the initial prevention visit), patients will be invited to receive ongoing support from a trained, volunteer peer health coach, for up to six months. The coach will support the patient as she works towards achieving personalized health goals to reduce her risk of chronic diseases, including cancer. |
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient identifies as a woman;
- Patient is 40-68yo;
- Patient has an email address;
- Patient has at least one behavioural risk factor not at target or at least one cancer screening overdue as defined below:
- Patient has a valid number for the provincial health insurance program (Ontario Health Insurance Program [OHIP]); and
Key exclusion criteria (3 listed)
- Patient is unable to give informed consent in English due to language, literacy, or competence;
- Patient is unable or unwilling to communicate with the study team to collect outcomes in English via both email and phone; or
- Patient's primary care provider has identified medical comorbidities or other conditions at baseline that might interfere with the patient's ability to follow through on the intervention.
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 |
|---|---|---|
| Prevention VisitPatients will have a one-on-one, approximately one-hour long visit with a specially trained Prevention Practitioner. During this visit, they will discuss the patient's health history, their risks for developing chronic diseases, including cancer, and possible steps they can take to reduce those risks. The Prevention Practitioner will also assist the patient to develop and articulate specific goals the patient would like to work on to reduce their risk of chronic diseases. | Other | Intervention, Wait-list Control |
| Peer health coachingPatients will be invited to register with the software platform used to facilitate peer health coaching. Once they have registered, they will be matched to a peer health coach who will connect with the patient to initiate the process. The coach will work collaboratively with the patient to help her follow through on a step-wise, personalized plan to achieve health goals that were developed with their prevention practitioner. The coach's approach will be informed by principles of brief action planning and motivational interviewing. Coaches will also provide social support, help to navigate to relevant information and community resources, and advise about options for self-monitoring. Coaching will occur over 12-16 sessions via phone calls, text messages, video calls and/or in-person meetings as desired/convenient and in accordance with local public health guidelines. | Behavioural | Intervention |
Primary outcome
Increased targeted behaviours from baseline
Time frame: 0, 6 months
The primary outcome is binary and defined as whether a patient increased the number of completed targeted behaviours from baseline to end of follow-up at 6 months. The targeted behaviours include the status (up to date or out of date) of three cancer screening tests (cervical, breast, colorectal) and the status (meeting evidence-based target or not) of four behavioural determinants for risk of cancer and chronic disease (diet, smoking, alcohol use, physical activity). If a patient meets at least one more target at 6 months than they met at baseline, their outcome will be considered positive.
32 secondary outcomes
Goal achievement
Time frame: 0, 6 months; 12 months for intervention group only
Breast cancer screening status
Time frame: 0, 6 months
Cervical cancer screening status
Time frame: 0, 6 months
Colorectal cancer screening status
Time frame: 0, 6 months
Diet status
Time frame: 0, 3, 6 months; 12 months for intervention group only
Improvement in diet
Time frame: 0, 3, 6 months; 12 months for intervention group only
Diet management
Time frame: 0, 3, 6 months; 12 months for intervention group only
Physical activity status
Time frame: 0, 3, 6 months; 12 months for intervention group only
Improvement in physical activity
Time frame: 0, 3, 6 months; 12 months for intervention group only
Physical activity management
Time frame: 0, 3, 6 months; 12 months for intervention group only
Smoking status
Time frame: 0, 3, 6 months; 12 months for intervention group only
Improvement in smoking
Time frame: 0, 3, 6 months; 12 months for intervention group only
Smoking management
Time frame: 0, 3, 6 months; 12 months for intervention group only
Alcohol use status
Time frame: 0, 3, 6 months; 12 months for intervention group only
Improvement in alcohol use
Time frame: 0, 3, 6 months; 12 months for intervention group only
Alcohol use management
Time frame: 0, 3, 6 months; 12 months for intervention group only
Up-to-date measurement of glycated haemoglobin (HbA1c)
Time frame: 0, 6 months; 12 months for intervention group only
HbA1c control
Time frame: 0, 6 months; 12 months for intervention group only
HbA1c
Time frame: 0, 6 months; 12 months for intervention group only
Glycemic management
Time frame: 0, 3, 6 months; 12 months for intervention group only
Up-to-date measurement of blood pressure (BP)
Time frame: 0, 6 months; 12 months for intervention group only
BP control
Time frame: 0, 6 months; 12 months for intervention group only
Systolic BP
Time frame: 0, 6 months; 12 months for intervention group only
Diastolic BP
Time frame: 0, 6 months; 12 months for intervention group only
Hypertension management
Time frame: 0, 3, 6 months; 12 months for intervention group only
Up-to-date assessment of low-density lipoprotein (LDL) cholesterol
Time frame: 0, 6 months; 12 months for intervention group only
LDL control
Time frame: 0, 6 months; 12 months for intervention group only
LDL
Time frame: 0, 6 months; 12 months for intervention group only
LDL cholesterol management
Time frame: 0, 3, 6 months; 12 months for intervention group only
Up-to-date assessment for obesity
Time frame: 0, 6 months; 12 months for intervention group only
BMI control
Time frame: 0, 6 months; 12 months for intervention group only
Management of obesity
Time frame: 0, 3, 6 months; 12 months for 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 19 Aug 2026.
- Background: PubMed 24252125Grunfeld E, Manca D, Moineddin R, Thorpe KE, Hoch JS, Campbell-Scherer D, Meaney C, Rogers J, Beca J, Krueger P, Mamdani M; BETTER Trial Investigators. Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial. BMC Fam Pract. 2013 Nov 20;14:175. doi: 10.1186/1471-2296-14-175.
- Background: PubMed 24191075Bodenheimer TS, Smith MD. Primary care: proposed solutions to the physician shortage without training more physicians. Health Aff (Millwood). 2013 Nov;32(11):1881-6. doi: 10.1377/hlthaff.2013.0234.
- Derived from this study: PubMed 39053957Kithulegoda N, Williams C, Senthilmurugan A, Aimola S, Atkinson J, Banerjee AT, Bazeghi F, Bender JL, Flynn S, Ghatage L, Goulbourne E, Grunfeld E, Heisey R, Rao A, Sutcliffe K, Lofters A, Ivers NM. Assessing the effectiveness of "BETTER Women", a community-based, primary care-linked peer health coaching programme for chronic disease prevention: protocol for a pragmatic, wait-list controlled, type 1 hybrid effectiveness-implementation trial. BMJ Open. 2024 Jul 24;14(7):e085933. doi: 10.1136/bmjopen-2024-085933.
- Information about the Alcohol Use Disorders Identification Test (AUDIT)Link provided by the sponsor.
- Mediterranean Diet Toolkit (Nov 2018) by Dietitians of CanadaLink provided by the sponsor.
- The screening tool used to provide the physical activity index (PAI)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified participant data will be available for analysis. Data will be shared through secure platforms compliant with PHIPA. Researchers must submit a data access request, including their research proposal, analysis plan, and research ethics board approval. Types of Data Available: Baseline and follow-up (3-, 6-, and 12-month) surveys, BETTER Health Survey, Prevention Prescription and Goals, and relevant outcomes from electronic medical records. Other Available Documents: Protocol, Survey Instruments, Interview guides Applicable Analyses: Health outcomes and behavior change; Economic evaluations; Implementation and process evaluations; Exploratory analyses on effect modifiers and mechanisms of action; Comparative studies on intervention efficacy Privacy and Confidentiality: All data will be de-identified to protect participant privacy. Data transfer and storage will comply with PHIPA. Data will be securely stored in a database with access limited to authorized personnel.
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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.
Noah M Ivers, MD, PhD principal investigator
Women's College Hospital
Aisha Lofters, MD, PhD principal investigator
Women's College Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention Visit and Peer health coaching in people with Chronic Disease and Cancer, run by Women's College Hospital at 3 sites 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 11 inclusion and 3 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Increased targeted behaviours from baseline (time frame: 0, 6 months). 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 NCT04746859, which also lists 3 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 19 Aug 2026.