Recruiting

Counseling & Activity

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT07142512

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Step Count tracking and goals

Dyadic coping intervention

Study Details

Brief 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.

Conditions

Type 2 Diabetes

Study ID

NCT07142512

Start date

Oct 1, 2025

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Step Count tracking and goals alone

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.

experimental: Step Count tracking and goals with dyadic coping intervention

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.

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.

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) ]

Central Contacts and Locations

Central contacts

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 0B1

Contacts

Principal Investigator:

Kaberi Dasgupta, MDCM, MSc, FRCPC

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Type 2 diabetes
  • Partner
  • Spouse
  • Wife
  • Husband
  • Step counts
  • Step targets
  • Hemoglobin A1C
  • Couple counseling
  • Dyadic coping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-05-07.