Couples Communication + Step Tracking for Type 2 Diabetes

(PartnerStepT2D Trial)

Not yet recruiting at 2 trial locations

Overseen By Debora Rosa, BSc

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

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

Disqualifiers: Gait difficulties, Impede walking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of step tracking and communication coaching (dyadic coping intervention) can help people with type 2 diabetes improve blood sugar control and heart health. Participants and their partners will wear step counters and receive step goals. Half of the couples will also attend sessions to enhance communication and support. The study aims to determine if better communication leads to more physical activity and improved health outcomes. Couples who have lived together for at least two years and can walk comfortably might be suitable candidates. As a Phase 2/3 trial, this study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to significant diabetes research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on increasing physical activity and improving communication with your partner.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dyadic coping interventions, which enhance communication and support between partners, are generally well-received. One study found that when couples collaborate to manage health conditions like type 2 diabetes, their relationships improve, and stress for the person with diabetes decreases. Reports also indicate that these interventions can enhance mental health and relationship satisfaction.

Although the data does not specifically mention any negative effects from dyadic coping strategies, it suggests that these interventions are safe for participants. They primarily involve communication exercises and setting shared goals, which are unlikely to cause physical harm. Participants often report feeling more supported by their partner.

Overall, evidence supports that dyadic coping interventions are safe and beneficial for couples managing type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Couples Communication + Step Tracking for Type 2 Diabetes because it explores how a dyadic coping intervention can enhance diabetes management. Unlike standard treatments that focus solely on individual medication and lifestyle changes, this approach looks at the power of teamwork, encouraging couples to support each other in managing the condition together. By combining step tracking with relationship-based strategies, the trial aims to see if this dual approach can lead to better health outcomes and increased motivation to stick with lifestyle changes. This innovative method could potentially offer a more holistic way to tackle diabetes, beyond just medication and diet changes.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research shows that couples working together can help manage type 2 diabetes. In this trial, one group will receive step count tracking and goals alone, while another group will receive the same step tracking and goals along with a dyadic coping intervention. Studies have found that when partners support each other, they both tend to make healthier choices. Specifically, one study found that couples who improved their communication had better control of their blood sugar levels. Another study found that couples who used coping strategies together were better at sticking to healthy diets and exercise plans. These findings suggest that involving partners in managing diabetes can lead to better health outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Shirin Golchi, PhD

Principal Investigator

McGill University

Jean-Philippe Gouin, PhD

Principal Investigator

Concordia University, Montreal

Kaberi Dasgupta, MDCM, MSc, FRCPC

Principal Investigator

Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for couples where one partner has type 2 diabetes. They should be willing to use a step counter, set walking goals with their doctor, and possibly attend counseling sessions to improve communication. Couples will be categorized by relationship quality and body size.

Inclusion Criteria

Index participant has T2D

I have been living with my partner for at least 2 years.

Willingness to complete an audiovisual recording of a conversation between the couple members to capture couple communication styles

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive step count tracking and goals, with or without dyadic coping intervention, for 24 weeks

24 weeks

Weekly step count goals and monitoring

Follow-up

Participants are monitored for changes in physical activity, blood sugar control, and other health metrics

4 weeks

Qualitative Assessment

Exit in-depth interviews to explore experiences of couples in the dyadic coping intervention arm

Until theme saturation

What Are the Treatments Tested in This Trial?

Interventions

• Dyadic coping intervention

Trial Overview The study tests if having support from a partner through improved communication can help people with type 2 diabetes increase physical activity and control blood sugar better when following a 'step prescription' program.

How Is the Trial Designed?

Group I: Step Count tracking and goals with dyadic coping intervention Experimental Treatment 2 Interventions

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 II: Step Count tracking and goals alone Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Diabetes Canada

Collaborator

Trials

13

Recruited

1,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6408270/

Two for one? Effects of a couples intervention on partners ... Aims. To compare the outcomes of partners who participated in a telephone couples behavioural intervention to improve glycaemic control in persons with Type 2 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07142512

Does This Help Persons With Type 2 Diabetes Respond ... We will examine a dyadic coping intervention that we have developed, in terms of its efficacy in stimulating positive behaviour changes in PWD who have partners ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/13591053241240735

How dyadic appraisal moderate the association between ... Johnson et al. reported that common dyadic coping was associated with higher levels of diabetes efficacy for both patients and spouses where one ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4233134/

Common Dyadic Coping Is Indirectly Related to Dietary and ... The current study proposes that common dyadic coping may be a general relationship process associated with better dietary and exercise adherence indirectly.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798389

Health Coaching for Patient-Family Dyads to Improve ... In this randomized clinical trial with 239 patient-supporter dyads, CO-IMPACT improved patient activation, diabetes self-efficacy, and healthy eating.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6082133/

Communally Coping with Diabetes: An Observational ... Communal coping is a form of interpersonal coping that involves a shared illness appraisal and collaborating to address illness-related issues.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0272735823001022

Dyadic coping and mental health in couples: A systematic ... In this systematic review, we summarize research examining dyadic coping (DC) in the context of mental health and individual and relational outcomes.

8. tandfonline.com tandfonline.com/doi/full/10.1080/17437199.2024.2307534

Compendium of dyadic intervention techniques (DITs) to ... The most commonly used dyadic intervention techniques instructed the couples to practice communication skills, to practice (other) skills, or to engage in ...

9. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.624609/full

Disability as an Interpersonal Experience: A Systematic ... In couples facing type 2 diabetes, communal coping was related to better relationship quality perceived by the patient and reduced patient ...