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

NCT07142512 | Not Yet Recruiting DMC

• 1 other identifier: OG-323-5723-KD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary outcome is at 24 weeks and a secondary outcome will be at 12 weeks (midpoint)

Secondary Outcomes (5)

• Change in A1C

  24 weeks

• Change in insulin resistance

  24 weeks

• Change in systolic blood pressure

  24 weeks

• Total steps

  24 weeks

• Dyadic coping

  24 weeks

Other Outcomes (11)

• Change in body mass index (BMI)

  24 weeks

• Change in marital quality

  24 weeks

• Change in high-density lipoprotein cholesterol (HDL)

  24 weeks

Study Arms (2)

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.

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.

Behavioral: Step Count tracking and goals; Behavioral: Dyadic coping intervention

Interventions

Step Count tracking and goals BEHAVIORAL

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.)

Step Count tracking and goals alone; Step Count tracking and goals with dyadic coping intervention

Dyadic coping intervention BEHAVIORAL

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.

Step Count tracking and goals with dyadic coping intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Diabetes Canada: collaborator

Study Sites (3)

St. Mary's Hospital

Montreal, Quebec, H3T 0A2, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 0B1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kaberi Dasgupta, MDCM, MSc, FRCPC

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Jean-Philippe Gouin, PhD

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

• Shirin Golchi, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debora Rosa, BSc

CONTACT

1-438-346-0479; debora.rosa@rimuhc.ca

Deborah Chan, BSc

CONTACT

1-514-934-1934; debbie.chan@rimuhc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The technicians who perform the assays (hemoglobin A1C, lipid profiles) are masked to study arm. Steps/day measurements are captured through step counting devices. Blood pressure and weight are assessed through automated devices.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, Professor of Medicine, Physician

Model Details: 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).

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

CA (3)