Clinical Research Directory
Browse clinical research sites, groups, and studies.
Helping Couples Communicate Better: Does This Help Persons With Type 2 Diabetes Respond Better to a Step Count Prescription?
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
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. 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.
Official title: A Dyadic Coping Strategy to Enhance Step Prescription Effects in Type 2 Diabetes: a Bayesian Adaptive Basket Randomized Controlled Trial
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-12
Completion Date
2027-12
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
Step Count tracking and goals
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 intervention
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.
Locations (3)
St. Mary's Hospital
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada