Helping couples communicate better to improve step-count prescriptions for people with type 2 diabetes
A Dyadic Coping Strategy to Enhance Step Prescription Effects in Type 2 Diabetes: a Bayesian Adaptive Basket Randomized Controlled Trial
This project will test whether teaching couples better ways to communicate, alongside giving both partners step-count prescriptions, helps people with type 2 diabetes walk more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Trial ID | NCT07142512 on ClinicalTrials.gov |
What this trial studies
The trial enrolls people with type 2 diabetes who live with a partner to compare two approaches for increasing daily steps. All participants and their partners receive step counters and a SMARTER step-prescription program; half the couples are randomized to also receive a dyadic coping (communication) intervention. Investigators will track step counts over time, collect baseline and follow-up measures, and record a couple conversation to analyze communication styles. Eligible participants are age 45 or older, cohabiting for at least two years, able to walk, and must have smartphone and internet access; the trial is conducted at McGill-affiliated hospitals in Montreal.
Who should consider this trial
Good fit: Ideal candidates are adults 45 or older with type 2 diabetes who live with a partner for two or more years, can walk without major impairment, and have a smartphone and internet access.
Not a fit: People without a cohabiting partner, those with gait-limiting conditions, those unwilling to record couple conversations, or those without smartphone/internet access are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the combined approach could help people with type 2 diabetes increase daily walking, improving blood sugar control and cardiovascular health.
How similar studies have performed: Previous trials of the SMARTER step-prescription approach have increased physical activity, but adding a structured dyadic coping communication intervention to step prescriptions is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (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.
Where this trial is running
Montreal, Quebec and 2 other locations
- St. Mary's Hospital — Montreal, Quebec, Canada (Not_yet_recruiting)
- Jewish General Hospital — Montreal, Quebec, Canada (Not_yet_recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Kaberi Dasgupta, MDCM, MSc, FRCPC — Research Institute of the McGill University Health Centre
- Study coordinator: Debora Rosa, BSc
- Email: debora.rosa@rimuhc.ca
- Phone: 1-438-346-0479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.