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NCT07142512Recruiting

Helping Couples Communicate Better: Does This Help Persons With Type 2 Diabetes Respond Better to a Step Count Prescription?

A Dyadic Coping Strategy to Enhance Step Prescription Effects in Type 2 Diabetes: a Bayesian Adaptive Basket Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 7 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
19 Aug 2025
Start date
1 Oct 2025
Primary completion date
Aug 2027
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
NCT number
NCT07142512

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 1 Oct 2025 to the primary completion date, Aug 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • (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.

Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McGill University Health Centre
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Jewish General Hospital
Coordinator of this site? Confirm its status
MontrealCanadaNot yet recruiting
St. Mary's Hospital
Coordinator of this site? Confirm its status
MontrealCanadaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.