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

NCT ID: NCT07142512

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

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.

Detailed Description

Persons with type 2 diabetes (T2D; henceforth, persons with diabetes, PWD) face personal (e.g., time pressure, competing priorities), social (e.g., food commercialization, employment and leisure digitization, inequity), and psychological (e.g., distress) challenges in addressing key behaviours that affect glycemic control, cardiometabolic profiles, and T2D complications. These behaviours include excess calorie intake, consumption of low nutrient quality food and beverages, low physical activity, high sedentary time, and poor sleep habits. Partners are potential assets in supporting positive health behaviour change. They often share lifestyle behaviours and may be at risk for similar outcomes. However, some couples may need adjustments in communication and relational dynamics, to work collaboratively towards healthier behaviours.

The investigators will examine a dyadic coping intervention that the investigators have developed, in terms of its efficacy in stimulating positive behaviour changes in PWD who have partners. In this study, the behaviours that the investigators will specifically focus on are low physical activity and high sedentary time. The investigators will apply an adapted version of our trial-tested SMARTER step count prescription strategy, now integrated into Diabetes Canada guidelines. The investigators will compare its effects alone vs. combined with our dyadic coping intervention, on step counts in persons with type 2 diabetes and their partners. The investigators will also examine changes in hemoglobin A1C in the index participant with type 2 diabetes. In the spirit of precision medicine and statistical efficiency, the investigators will apply an adaptive basket trial design to delineate in which profiles (marital quality [Couples Satisfaction Index-16 divided as score < 61 vs. 61 or higher] , concordance for BMI > 30 kg/m2 vs. not) the dyadic coping intervention is likely to demonstrate efficacy. Couples with higher marital quality and/or shared impact of less healthy behaviours or environments (as reflected by concordance in excess weight) may experience stronger impact of the intervention.

In addition to the outcomes described below, the investigators will assess participant perspectives regarding the dyadic coping intervention. Through a descriptive qualitative approach (exit in-depth interviews), the investigators will explore experiences of couples in the dyadic coping intervention arm. The investigators will use a semi-structured interview approach, using the guide that the investigators have developed. The investigators will interview both members of the couple together, by telephone. The investigators will continue sampling until saturation of themes occurs. The investigators will audio record and transcribe the interviews. Two trained investigators will read and code for themes. Data coding/organisation will be facilitated by Dedoose Version 7.0.23 and NVivo analysis software. Data analysis will be informed by thematic analyses.

What did the participant like about the approach? (coaching, step monitoring, goals) What did the participant not like? How would the participant improve the approach? How were the number of coaching sessions? Too many? Too few? How was the length of the coaching sessions? Too long? Too short?

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Step Count tracking and goals

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Step Count tracking and goals

Intervention Type: 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.)

Dyadic coping intervention

Intervention Type: 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.

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.)

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diabetes Canada

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Kaberi Dasgupta, MD, MSc, FRCP (C)

Senior Scientist, Professor of Medicine, Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaberi Dasgupta, MDCM, MSc, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Research Institute of the McGill University Health Centre

Jean-Philippe Gouin, PhD

Role: PRINCIPAL_INVESTIGATOR

Concordia University, Montreal

Shirin Golchi, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

St. Mary's Hospital

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Debora Rosa, BSc

Role: CONTACT

debora.rosa@rimuhc.ca

1-438-346-0479

Deborah Chan, BSc

Role: CONTACT

debbie.chan@rimuhc.ca

1-514-934-1934 ext. 44835

Facility Contacts

Debora Rosa, BSc

Role: primary

debora.rosa@rimuhc.ca

1-438-346-0479

Deborah Chan, BSc

Role: backup

debbie.chan@rimuhc.ca

1-514-934-1934

Debora Rosa, BSc

Role: primary

debora.rosa@rimuhc.ca

1-438-346-0479

Deborah Chan, BSc

Role: backup

debbie.chan@rimuhc.ca

1-514-934-1934 ext. 44835

Debora Rosa, BSc

Role: primary

debora.rosa@rimuhc.ca

1-438-346-0479

Deborah Chan, BSc

Role: backup

debbie.chan@rimuhc.ca

1-514-934-1934 ext. 44835

Other Identifiers

OG-323-5723-KD

Identifier Type: -

Identifier Source: org_study_id