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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.)

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Step Count tracking and goals aloneActive comparator 1 intervention
Group B: Step Count tracking and goals with dyadic coping interventionExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Change in A1C

We will assess the difference between hemoglobin A1C (measure of glycemic control) between baseline and final assessment.

Time frame
24 weeks
2

Change in insulin resistance

We will assessed fasting insulin and fasting glucose levels at baseline and following the intervention. We will use these values to compute the Homeostatic Model Assessment-Insulin Resistance \[HOMA-IR\] measure.

Time frame
24 weeks
3

Change in systolic blood pressure

We will evaluate the change in systolic blood pressure between baseline and final assessments. This will be based on the average of 5 sequential automated oscillometric blood pressure monitor-assessed values.

Time frame
24 weeks
4

Total steps

We will sum total steps over the study period.

Time frame
24 weeks

Other outcomes

1

Change in body mass index (BMI)

We will assess the difference in BMI between baseline and final assessments. We will use measured weight (digital scale) and height (stadiometer) values to compute BMI as weight in kilograms divided by height in meters squared.

Time frame
24 weeks
2

Change in marital quality

In both index participants and their partners, we will assess the difference between questionnaire-assessed marital quality during the first week and the final week of the intervention. We will use the Couples Satisfaction Index (16 item version; score range 0 to 80). Reference: Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007;21(4):572-83.

Time frame
24 weeks
3

Change in high-density lipoprotein cholesterol (HDL)

We will evaluate the difference in HDL between baseline and final assessments.

Time frame
24 weeks
4

Change in self-efficacy for physical activity

We are using reactions to the following questions to assess physical activity-related self-efficacy (5-point Likert scale- strong disagree, disagree, neutral, agree, strongly agree): I possess the skills to do regular physical activity over the next 6 months if I wanted to. I have the ability to do regular physical activity over the next 6 months if I wanted to. I am confident that I am capable of engaging in regular physical activity if I had to. We will use similar questions to assess perceptions of the partner's self-efficacy, substituting 'my partner' for 'I' in the above series of questions. Both the index participant and the partner participant will answer both series of questions. Reference: Burrell AMG, Allan JL, Williams DM, et al. What do self-efficacy items measure? Examining the discriminant content validity of self-efficacy items. British journal of health psychology. 2018;23(3):597-611.

Time frame
24 weeks

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