A Dyadic Coping Strategy to Enhance Step Prescription Effects in Type 2 Diabetes: a Bayesian Adaptive Basket Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Change in steps/day
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Step Count tracking and goals (Behavioral)
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.
干预措施: Step Count tracking and goals (Behavioral)
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.
干预措施: Dyadic coping intervention (Behavioral)
结局指标
主要结局
Change in steps/day
时间窗: The primary outcome is at 24 weeks and a secondary outcome will be at 12 weeks (midpoint)
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.
次要结局
- Change in A1C(24 weeks)
- Change in systolic blood pressure(24 weeks)
- Dyadic coping(24 weeks)
- Change in insulin resistance(24 weeks)
- Total steps(24 weeks)
研究者
Kaberi Dasgupta, MD, MSc, FRCP (C)
Senior Scientist, Professor of Medicine, Physician
McGill University Health Centre/Research Institute of the McGill University Health Centre