RecruitingRecruiting
Helping Couples Communicate Better: Does This Help Persons With Type 2 Diabetes Respond Better to a Step Count Prescription?
NCT07142512 · McGill University Health Centre/Research Institute of the McGill University Health Centre
In plain English
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Official title
A Dyadic Coping Strategy to Enhance Step Prescription Effects in Type 2 Diabetes: a Bayesian Adaptive Basket Randomized Controlled Trial
About this study
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?
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.
Study design
Enrollment target: 200 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-01
Estimated completion: 2027-12
Last updated: 2026-05-07
Interventions
Behavioral: Step Count tracking and goalsBehavioral: Dyadic coping intervention
Primary outcomes
- • Change in steps/day (The primary outcome is at 24 weeks and a secondary outcome will be at 12 weeks (midpoint))
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · other
With: Diabetes Canada
Contacts & investigators
ContactDebora Rosa, BSc · contact · debora.rosa@rimuhc.ca · 1-438-346-0479
ContactDeborah Chan, BSc · contact · debbie.chan@rimuhc.ca · 1-514-934-1934
InvestigatorKaberi Dasgupta, MDCM, MSc, FRCPC · principal_investigator, Research Institute of the McGill University Health Centre
InvestigatorJean-Philippe Gouin, PhD · principal_investigator, Concordia University, Montreal
InvestigatorShirin Golchi, PhD · principal_investigator, McGill University
All locations (3)
St. Mary's HospitalNot Yet Recruiting
Montreal, Quebec, Canada
Jewish General HospitalNot Yet Recruiting
Montreal, Quebec, Canada
McGill University Health CentreRecruiting
Montreal, Quebec, Canada