Type 2 DiabetesPartnerStepT2DNCT07142512
Helping Couples Communicate Better: Does This Help Persons With Type 2 Diabetes Respond Better to a Step Count Prescription?
A study testing Step Count tracking and goals and Dyadic coping intervention in people with Type 2 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
Trial summary
Being active is one way to reach better blood sugar control and heart health in type 2 diabetes. The investigators developed a strategy to help people with type 2 diabetes walk more. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Step Count tracking and goals and Dyadic coping intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (i) Index participant has T2D;
- (ii) Index participant 45 years of age or older;
- (iii) Index participant and partner: Co-habiting with a partner (same or different sex) for two or more years;
- (iv) Index participant and partner: Absence of gait difficulties or other co-morbid conditions that impede walking in the index participant;
- (v) Willingness to complete an audiovisual recording of a conversation between the couple members to capture couple communication styles
- (vi) Index participant and partner Smartphone and Internet access.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Not yet recruiting
St. Mary's Hospital
Montreal, Quebec, H3T 0A2
Debora Rosa, BSc, 1-438-346-0479, debora.rosa@rimuhc.ca
Deborah Chan, BSc, 1-514-934-1934, debbie.chan@rimuhc.ca
- Not yet recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Debora Rosa, BSc, 1-438-346-0479, debora.rosa@rimuhc.ca
Deborah Chan, BSc, 1-514-934-1934 ext. 44835, debbie.chan@rimuhc.ca
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 0B1
Debora Rosa, BSc, 1-438-346-0479, debora.rosa@rimuhc.ca
Deborah Chan, BSc, 1-514-934-1934 ext. 44835, debbie.chan@rimuhc.ca
About this study
Official title: A Dyadic Coping Strategy to Enhance Step Prescription Effects in Type 2 Diabetes: a Bayesian Adaptive Basket Randomized Controlled Trial
Being active is one way to reach better blood sugar control and heart health in type 2 diabetes. The investigators developed a strategy to help people with type 2 diabetes walk more. They track their steps with a step counter and set targets with their doctor through a kind of 'step prescription.' While this strategy helps people increase their physical activity, it can be useful to have support besides the clinic visits. Their partner might be a good person to help.
Partners often have similar activity levels. Partners of people with type 2 diabetes are also more likely to develop type 2 diabetes. There are good reasons to work together! However, not all partners communicate in a way that helps them work together effectively. The investigators are going to give a step counter and step prescriptions to a large group of people with type 2 diabetes. The partners will also receive counters and step prescriptions. Half of the couples will be randomized (assigned to a group based on something equivalent to a coin toss) to participate in online or in-person sessions with a counselor. They will work together to figure out how to communicate more kindly and effectively. The investigators will see if the people with these sessions wind up having higher steps and better sugar control than the people who do not. To figure out in which types of couples the strategy works, The investigators will also divide the couples into groups based on the type of marriage that they have (figured out through a questionnaire) and body size. The investigators will see if the counseling strategy helps in both 'high' and 'low' quality relationships and if couples where both partners have extra weight respond differently to the strategy than other couples. During the trial, if The investigators see that the strategy is not working well in one particular group of people, The investigators may recruit fewer in this group and more in the others. The investigators will do this in consultation with specialized statisticians who will look at the data at specific points in time. This is a way of making sure that the investigators are testing the right strategy in the right group, increasing the 'efficiency' and relevance of the study.
Read the detailed description
Persons with type 2 diabetes (T2D; henceforth, persons with diabetes, PWD) face personal (e.g., time pressure, competing priorities), social (e.g., food commercialization, employment and leisure digitization, inequity), and psychological (e.g., distress) challenges in addressing key behaviours that affect glycemic control, cardiometabolic profiles, and T2D complications. These behaviours include excess calorie intake, consumption of low nutrient quality food and beverages, low physical activity, high sedentary time, and poor sleep habits. Partners are potential assets in supporting positive health behaviour change. They often share lifestyle behaviours and may be at risk for similar outcomes. However, some couples may need adjustments in communication and relational dynamics, to work collaboratively towards healthier behaviours.
The investigators will examine a dyadic coping intervention that the investigators have developed, in terms of its efficacy in stimulating positive behaviour changes in PWD who have partners. In this study, the behaviours that the investigators will specifically focus on are low physical activity and high sedentary time. The investigators will apply an adapted version of our trial-tested SMARTER step count prescription strategy, now integrated into Diabetes Canada guidelines. The investigators will compare its effects alone vs. combined with our dyadic coping intervention, on step counts in persons with type 2 diabetes and their partners. The investigators will also examine changes in hemoglobin A1C in the index participant with type 2 diabetes. In the spirit of precision medicine and statistical efficiency, the investigators will apply an adaptive basket trial design to delineate in which profiles (marital quality [Couples Satisfaction Index-16 divided as score < 61 vs. 61 or higher] , concordance for BMI > 30 kg/m2 vs. not) the dyadic coping intervention is likely to demonstrate efficacy. Couples with higher marital quality and/or shared impact of less healthy behaviours or environments (as reflected by concordance in excess weight) may experience stronger impact of the intervention.
In addition to the outcomes described below, the investigators will assess participant perspectives regarding the dyadic coping intervention. Through a descriptive qualitative approach (exit in-depth interviews), the investigators will explore experiences of couples in the dyadic coping intervention arm. The investigators will use a semi-structured interview approach, using the guide that the investigators have developed. The investigators will interview both members of the couple together, by telephone. The investigators will continue sampling until saturation of themes occurs. The investigators will audio record and transcribe the interviews. Two trained investigators will read and code for themes. Data coding/organisation will be facilitated by Dedoose Version 7.0.23 and NVivo analysis software. Data analysis will be informed by thematic analyses.
What did the participant like about the approach? (coaching, step monitoring, goals) What did the participant not like? How would the participant improve the approach? How were the number of coaching sessions? Too many? Too few? How was the length of the coaching sessions? Too long? Too short?
- Conditions
- Type 2 Diabetes
- Being tested
- Step Count tracking and goals, Dyadic coping intervention
- Keywords
- Type 2 diabetes, Partner, Spouse, Wife, Husband, Step counts, Step targets, Hemoglobin A1C, Couple counseling, Dyadic coping
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step Count tracking and goalsBehavioural
We will provide participants and partners with Fitbits for the duration of the trial. After one week of step counting, the next week target will be to increase by 500 steps/day if baseline < 5000 steps/day; increase by 750 steps/day if baseline 5000 to 7,500 steps/day; and increase by 1,000 steps/day if baseline > 7,500 steps/day). Each week thereafter, study staff will pull the step data and apply an algorithm to generate new targets for the next week. In our algorithm, subsequent targets are higher if the participant exceeds prior week targets, and lower/unchanged if below target. This is similar to the algorithm we used in our trial ACTIVE PATIENT GDM (Dasgupta K, Chan D, Bond R, Garfield N, Coolen J, Halperin IJ, Peters TM, et al. Step and weight tracking with targets and coaching interventions in gestational diabetes: A randomized factorial feasibility trial. Diabetes Res Clin Pract. 2025 Jun;224:112241. doi: 10.1016/j.diabres.2025.112241. Epub 2025 May 9. PMID: 40349846.)
Dyadic coping interventionBehavioural
Couples will participate in 8 one-hour coaching sessions over 12 weeks (virtual, in-person, or a combination, as preferred). The sessions aim to enhance the couple's understanding of how they influence each other. Both couple members will explore their preferences in terms of ways of communicating and supporting one another's goals. We will use changes in steps as a context to explore how partners can effectively support and "coach" each other without without eliciting behavioural reactance. We will use are goal setting, action planning, self-monitoring, graded tasks, social environment restructuring, and social support. The coaches will be psychology students. They will receive structured training on the coaching strategy from a licensed mental health professional. We will record the sessions for fidelity and quality assurance purposes. All coaches will meet weekly with the supervising licensed mental health professional.
| Study group | Role | What they receive |
|---|---|---|
| Step Count tracking and goals alone | Active comparator | We will provide this active comparator arm with weekly step count goals and a step counter for the 24 week study period. We provide further details in the description of the intervention with the same title. Receives: Behavioral: Step Count tracking and goals |
| Step Count tracking and goals with dyadic coping intervention | Experimental | This arm will receive the same step tracking and goal intervention described for the active comparator but will additionally participate in the dyadic coping intervention. Receives: Behavioral: Step Count tracking and goals; Behavioral: Dyadic coping intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in steps/day
Difference between mean baseline (week 1) and final (week 24) steps/day; daily steps are automatically uploaded to a secure cloud-based server and pulled by our research team for weekly goals and outcome assessment. We require at least 4 days of measurement. If sufficient days are not captured in week 1, we may compute based on the earliest of weeks 2 through 4 that includes sufficient data. If sufficient days are not captured in week 24, we may compute based on the latest of weeks 20 through 24 that includes sufficient data.
Measured: The primary outcome is at 24 weeks and a secondary outcome will be at 12 weeks (midpoint)
Secondary outcomes (5)
Change in A1C
We will assess the difference between hemoglobin A1C (measure of glycemic control) between baseline and final assessment.
Measured: 24 weeks
Change in insulin resistance
We will assessed fasting insulin and fasting glucose levels at baseline and following the intervention. We will use these values to compute the Homeostatic Model Assessment-Insulin Resistance [HOMA-IR] measure.
Measured: 24 weeks
Change in systolic blood pressure
We will evaluate the change in systolic blood pressure between baseline and final assessments. This will be based on the average of 5 sequential automated oscillometric blood pressure monitor-assessed values.
Measured: 24 weeks
Total steps
We will sum total steps over the study period.
Measured: 24 weeks
Dyadic coping
We assess this through the common dyadic coping subscale (5 questions) of the Dyadic coping inventory (each question with 5 Likert scale options). We will look at the difference in total score between baseline and final assessments.
Reference: Bodenmann G, Arista LJ, Walsh KJ, et al. Dyadic Coping Inventory. In: Lebow J, Chambers A, Breunlin DC, editors. Encyclopedia of Couple and Family Therapy. Cham: Springer International Publishing; 2018. p. 1-5.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Oct 2025
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- As discussed in the detailed description of the trial, this is a a Bayesian adaptive basket randomized controlled trial. There are 4 prespecified subgroups (high marital quality- lower marital quality, both partners with obesity- one or neither with obesity).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Canada
- Responsible party
- Principal investigator, Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Kaberi Dasgupta, MDCM, MSc, FRCPC, Principal investigator, Research Institute of the McGill University Health CentreJean-Philippe Gouin, PhD, Principal investigator, Concordia University, MontrealShirin Golchi, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142512
- Sponsor's protocol ID
- OG-323-5723-KD
- Acronym
- PartnerStepT2D
- Status last verified
- May 2026
- First submitted
- 19 Aug 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Following completion of all trial procedures, we will perform the analyses and write the manuscript reporting the trial results. We may then consider data sharing on a case by case basis, subject to review of analysis plans, ethics review, and formal agreements.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dyadic Coping Strategy to Enhance Step Prescription Effects in Type 2 Diabetes: a Bayesian Adaptive Basket Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07142512
- Acronym / sponsor ID
- PartnerStepT2D / OG-323-5723-KD
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Partner, Spouse, Wife, Husband, Step counts, Step targets, Hemoglobin A1C
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Diabetes Canada
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Aug 2025 (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.
Being active is one way to reach better blood sugar control and heart health in type 2 diabetes. The investigators developed a strategy to help people with type 2 diabetes walk more. They track their steps with a step counter and set targets with their doctor through a kind of 'step prescription.' While this strategy helps people increase their physical activity, it can be useful to have support besides the clinic visits. Their partner might be a good person to help.
Partners often have similar activity levels. Partners of people with type 2 diabetes are also more likely to develop type 2 diabetes. There are good reasons to work together! However, not all partners communicate in a way that helps them work together effectively. The investigators are going to give a step counter and step prescriptions to a large group of people with type 2 diabetes. The partners will also receive counters and step prescriptions. Half of the couples will be randomized (assigned to a group based on something equivalent to a coin toss) to participate in online or in-person sessions with a counselor. They will work together to figure out how to communicate more kindly and effectively. The investigators will see if the people with these sessions wind up having higher steps and better sugar control than the people who do not. To figure out in which types of couples the strategy works, The investigators will also divide the couples into groups based on the type of marriage that they have (figured out through a questionnaire) and body size. The investigators will see if the counseling strategy helps in both 'high' and 'low' quality relationships and if couples where both partners have extra weight respond differently to the strategy than other couples. During the trial, if The investigators see that the strategy is not working well in one particular group of people, The investigators may recruit fewer in this group and more in the others. The investigators will do this in consultation with specialized statisticians who will look at the data at specific points in time. This is a way of making sure that the investigators are testing the right strategy in the right group, increasing the 'efficiency' and relevance of the study.
Detailed description
Persons with type 2 diabetes (T2D; henceforth, persons with diabetes, PWD) face personal (e.g., time pressure, competing priorities), social (e.g., food commercialization, employment and leisure digitization, inequity), and psychological (e.g., distress) challenges in addressing key behaviours that affect glycemic control, cardiometabolic profiles, and T2D complications. These behaviours include excess calorie intake, consumption of low nutrient quality food and beverages, low physical activity, high sedentary time, and poor sleep habits. Partners are potential assets in supporting positive health behaviour change. They often share lifestyle behaviours and may be at risk for similar outcomes. However, some couples may need adjustments in communication and relational dynamics, to work collaboratively towards healthier behaviours.
The investigators will examine a dyadic coping intervention that the investigators have developed, in terms of its efficacy in stimulating positive behaviour changes in PWD who have partners. In this study, the behaviours that the investigators will specifically focus on are low physical activity and high sedentary time. The investigators will apply an adapted version of our trial-tested SMARTER step count prescription strategy, now integrated into Diabetes Canada guidelines. The investigators will compare its effects alone vs. combined with our dyadic coping intervention, on step counts in persons with type 2 diabetes and their partners. The investigators will also examine changes in hemoglobin A1C in the index participant with type 2 diabetes. In the spirit of precision medicine and statistical efficiency, the investigators will apply an adaptive basket trial design to delineate in which profiles (marital quality [Couples Satisfaction Index-16 divided as score < 61 vs. 61 or higher] , concordance for BMI > 30 kg/m2 vs. not) the dyadic coping intervention is likely to demonstrate efficacy. Couples with higher marital quality and/or shared impact of less healthy behaviours or environments (as reflected by concordance in excess weight) may experience stronger impact of the intervention.
In addition to the outcomes described below, the investigators will assess participant perspectives regarding the dyadic coping intervention. Through a descriptive qualitative approach (exit in-depth interviews), the investigators will explore experiences of couples in the dyadic coping intervention arm. The investigators will use a semi-structured interview approach, using the guide that the investigators have developed. The investigators will interview both members of the couple together, by telephone. The investigators will continue sampling until saturation of themes occurs. The investigators will audio record and transcribe the interviews. Two trained investigators will read and code for themes. Data coding/organisation will be facilitated by Dedoose Version 7.0.23 and NVivo analysis software. Data analysis will be informed by thematic analyses.
What did the participant like about the approach? (coaching, step monitoring, goals) What did the participant not like? How would the participant improve the approach? How were the number of coaching sessions? Too many? Too few? How was the length of the coaching sessions? Too long? Too short?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- As discussed in the detailed description of the trial, this is a a Bayesian adaptive basket randomized controlled trial. There are 4 prespecified subgroups (high marital quality- lower marital quality, both partners with obesity- one or neither with obesity).
| Arm | Type | Receives |
|---|---|---|
| Step Count tracking and goals alone | Active comparator | Behavioral: Step Count tracking and goalsWe will provide this active comparator arm with weekly step count goals and a step counter for the 24 week study period. We provide further details in the description of the intervention with the same title. |
| Step Count tracking and goals with dyadic coping intervention | Experimental | Behavioral: Step Count tracking and goals, Behavioral: Dyadic coping interventionThis arm will receive the same step tracking and goal intervention described for the active comparator but will additionally participate in the dyadic coping intervention. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (i) Index participant has T2D;
- (ii) Index participant 45 years of age or older;
- (iii) Index participant and partner: Co-habiting with a partner (same or different sex) for two or more years;
- (iv) Index participant and partner: Absence of gait difficulties or other co-morbid conditions that impede walking in the index participant;
- (v) Willingness to complete an audiovisual recording of a conversation between the couple members to capture couple communication styles
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Step Count tracking and goalsWe will provide participants and partners with Fitbits for the duration of the trial. After one week of step counting, the next week target will be to increase by 500 steps/day if baseline < 5000 steps/day; increase by 750 steps/day if baseline 5000 to 7,500 steps/day; and increase by 1,000 steps/day if baseline > 7,500 steps/day). Each week thereafter, study staff will pull the step data and apply an algorithm to generate new targets for the next week. In our algorithm, subsequent targets are higher if the participant exceeds prior week targets, and lower/unchanged if below target. This is similar to the algorithm we used in our trial ACTIVE PATIENT GDM (Dasgupta K, Chan D, Bond R, Garfield N, Coolen J, Halperin IJ, Peters TM, et al. Step and weight tracking with targets and coaching interventions in gestational diabetes: A randomized factorial feasibility trial. Diabetes Res Clin Pract. 2025 Jun;224:112241. doi: 10.1016/j.diabres.2025.112241. Epub 2025 May 9. PMID: 40349846.) | Behavioural | Step Count tracking and goals alone, Step Count tracking and goals with dyadic coping intervention |
| Dyadic coping interventionCouples will participate in 8 one-hour coaching sessions over 12 weeks (virtual, in-person, or a combination, as preferred). The sessions aim to enhance the couple's understanding of how they influence each other. Both couple members will explore their preferences in terms of ways of communicating and supporting one another's goals. We will use changes in steps as a context to explore how partners can effectively support and "coach" each other without without eliciting behavioural reactance. We will use are goal setting, action planning, self-monitoring, graded tasks, social environment restructuring, and social support. The coaches will be psychology students. They will receive structured training on the coaching strategy from a licensed mental health professional. We will record the sessions for fidelity and quality assurance purposes. All coaches will meet weekly with the supervising licensed mental health professional. | Behavioural | Step Count tracking and goals with dyadic coping intervention |
Primary outcome
Change in steps/day
Time frame: The primary outcome is at 24 weeks and a secondary outcome will be at 12 weeks (midpoint)
Difference between mean baseline (week 1) and final (week 24) steps/day; daily steps are automatically uploaded to a secure cloud-based server and pulled by our research team for weekly goals and outcome assessment. We require at least 4 days of measurement. If sufficient days are not captured in week 1, we may compute based on the earliest of weeks 2 through 4 that includes sufficient data. If sufficient days are not captured in week 24, we may compute based on the latest of weeks 20 through 24 that includes sufficient data.
5 secondary outcomes
Change in A1C
Time frame: 24 weeks
Change in insulin resistance
Time frame: 24 weeks
Change in systolic blood pressure
Time frame: 24 weeks
Total steps
Time frame: 24 weeks
Dyadic coping
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided. Following completion of all trial procedures, we will perform the analyses and write the manuscript reporting the trial results. We may then consider data sharing on a case by case basis, subject to review of analysis plans, ethics review, and formal agreements.
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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.
Kaberi Dasgupta, MDCM, MSc, FRCPC principal investigator
Research Institute of the McGill University Health Centre
Jean-Philippe Gouin, PhD principal investigator
Concordia University, Montreal
Shirin Golchi, PhD principal investigator
McGill University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step Count tracking and goals and Dyadic coping intervention in people with Type 2 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 6 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 7 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debora Rosa, BSc (1-438-346-0479, debora.rosa@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in steps/day (time frame: The primary outcome is at 24 weeks and a secondary outcome will be at 12 weeks (midpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.