Developing Data Driven Algorithms for Predicting The Right Advice at The Right Time in Patients With Hip and Knee OsteoArthritis: The e-cOAch Cross-over Study
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Physical functioning
概览
简要总结
This study aims to learn how symptoms and daily functioning change over time in people with hip or knee osteoarthritis (OA). The goal is to use this information to build computer models that can predict these changes. In the future, these models may help give people with OA the right self-care advice at the right time through a web application called ArtroseCoach.
People with OA will take part in this study for one year. Every two weeks, they will fill in online questionnaires covering various aspects of their health and daily functioning, such as pain, daily activities, and participation in life. During the year, participants will be randomly assigned to one of several self-care programs in the ArtroseCoach web app. These programs focus on physical activity, weight management, or sleep. Each program lasts 12 weeks. At four points during the year (weeks 3, 15, 27, and 39), participants will receive one of these programs or no program at all. No one will receive the same program twice.
The ArtroseCoach web app provides education about OA, lifestyle advice, and tips to support behavior change. The study will help researchers understand which factors are linked to changes in pain and physical functioning over time. This knowledge will be used to improve the ArtroseCoach and other future tools that support people with OA in managing their condition on their own.
详细描述
Objectives of this study include the following:
The primary objective is to develop and evaluate data-driven models to support personalised recommendations regarding the optimal timing of self-management strategies (physical activity promotion, sleep optimization and weight management) in individuals with hip and/or knee OA.
Other objectives with data from this study:
To distinguish subgroups of people with hip/knee OA based on determinants of behavior.
To describe the course and predictive factors of flare-ups in patients with knee and hip osteoarthritis.
To describe how people with knee and/or hip osteoarthritis score on participation, and what factors influence participation.
To describe how people in the e-cOAch cross-over sleep and the association between weight, physical activity, pain and quality of sleep in people with osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Blinding is not applicable in this study, as participants actively engage with the assigned self-care module within the ArtroseCoach web application. Both participants and researchers are aware of the assigned intervention.
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
- •Have a hip or knee joint that, self-administered through a questionnaire, meets the National
- •Institute for Health and Care Excellence clinical criteria for osteoarthritis:
- •Aged 45 years or over and;
- •Activity-related pain at the joint and;
- •Joint morning stiffness that lasts no longer than 30 minutes or no morning stiffness at the joint;
- •History of pain at the joint for at least 3 months;
- •Have access to a smartphone with internet connection and an email address;
- •Able to give informed consent and willing to commit to all study evaluation and assessment procedures
- •Able to read and understand texts in Dutch at B1 level.
排除标准
- •Self-reported systemic arthritis (e.g., rheumatoid arthritis, gout) avoid confounding due to overlapping symptoms;
- •Scheduled for lower limb joint surgery within the next year or underwent lower limb joint surgery (total hip, total knee) the last year as surgical interventions could affect outcomes and confound the assessment of treatment effects.
研究组 & 干预措施
Order of arms 1. Physical activity → Weight management → Sleep → No intervention.
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 1. Physical activity → Weight management → Sleep → No intervention.
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 1. Physical activity → Weight management → Sleep → No intervention.
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 1. Physical activity → Weight management → Sleep → No intervention.
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 2: Physical activity → Weight management → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 2: Physical activity → Weight management → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 2: Physical activity → Weight management → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 2: Physical activity → Weight management → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 3: Physical activity → Sleep → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 3: Physical activity → Sleep → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 3: Physical activity → Sleep → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 3: Physical activity → Sleep → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 4: Physical activity → Sleep → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 4: Physical activity → Sleep → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 4: Physical activity → Sleep → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 4: Physical activity → Sleep → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 5: Physical activity → No intervention → Weight management → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 5: Physical activity → No intervention → Weight management → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 5: Physical activity → No intervention → Weight management → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 5: Physical activity → No intervention → Weight management → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 6: Physical activity → No intervention → Sleep → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 6: Physical activity → No intervention → Sleep → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 6: Physical activity → No intervention → Sleep → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 6: Physical activity → No intervention → Sleep → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 7: Weight management → Physical activity → Sleep → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 7: Weight management → Physical activity → Sleep → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 7: Weight management → Physical activity → Sleep → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 7: Weight management → Physical activity → Sleep → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 8: Weight management → Physical activity → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 8: Weight management → Physical activity → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 8: Weight management → Physical activity → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 8: Weight management → Physical activity → No intervention → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 9: Weight management → Sleep → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 9: Weight management → Sleep → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 9: Weight management → Sleep → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 9: Weight management → Sleep → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 10: Weight management → Sleep → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 10: Weight management → Sleep → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 10: Weight management → Sleep → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 10: Weight management → Sleep → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 11: Weight management → No intervention → Physical activity → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 11: Weight management → No intervention → Physical activity → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 11: Weight management → No intervention → Physical activity → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 11: Weight management → No intervention → Physical activity → Sleep
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 12: Weight management → No intervention → Sleep → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 12: Weight management → No intervention → Sleep → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 12: Weight management → No intervention → Sleep → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 12: Weight management → No intervention → Sleep → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 13: Sleep → Physical activity → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 13: Sleep → Physical activity → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 13: Sleep → Physical activity → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 13: Sleep → Physical activity → Weight management → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 14: Sleep → Physical activity → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 14: Sleep → Physical activity → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 14: Sleep → Physical activity → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 14: Sleep → Physical activity → No intervention → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 15: Sleep → Weight management → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 15: Sleep → Weight management → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 15: Sleep → Weight management → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 15: Sleep → Weight management → Physical activity → No intervention
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 16: Sleep → Weight management → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 16: Sleep → Weight management → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 16: Sleep → Weight management → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 16: Sleep → Weight management → No intervention → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 17: Sleep → No intervention → Physical activity → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 17: Sleep → No intervention → Physical activity → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 17: Sleep → No intervention → Physical activity → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 17: Sleep → No intervention → Physical activity → Weight management
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
Order of arms 18: Sleep → No intervention → Weight management → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Physical Activity program (Behavioral)
Order of arms 18: Sleep → No intervention → Weight management → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Sleep program (Behavioral)
Order of arms 18: Sleep → No intervention → Weight management → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Weight management program (Behavioral)
Order of arms 18: Sleep → No intervention → Weight management → Physical activity
This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ.
干预措施: Control: no intervention (Other)
结局指标
主要结局
Physical functioning
时间窗: From baseline until the end of the study at week 52, with assessments every 10 weeks
Measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS). HOOS includes 40 items and KOOS 42 items in five subdomains of physical functioning. Each item is rated on a 5-point Likert scale. The total scores range from 0 to 100; a higher score represents better physical functioning.
次要结局
- Numeric Pain Rating Scale(From baseline until the end of the study at week 52, measured every two weeks.)
- Participation(From baseline until the end of the study at week 52, measured every ten weeks.)
- Stiffness(From baseline until the end of the study at week 52, measured every two weeks.)
- Self-reported active minutes(From baseline until the end of the study at week 52, measured every two weeks.)
- Device measured active minutes(From baseline until the end of the study at week 52, with continuous measures.)
- Fatigue(From baseline until the end of the study at week 52, measured every ten weeks.)
- Job satisfaction(From baseline until the end of the study at week 52, measured every ten weeks.)
- Depression and Anxiety(From baseline until the end of the study at week 52, measured every ten weeks.)
- Experienced social support(From baseline until the end of the study at week 52, measured every ten weeks.)
- Kinesiophobia(From baseline until the end of the study at week 52, measured every ten weeks.)
- Self-efficacy(From baseline until the end of the study at week 52, measured every ten weeks.)
- Insomnia severity(From baseline until the end of the study at week 52, measured every ten weeks. This outcome is also reported at the start and end of the Sleep program (twelve weeks), the timing of the Sleep program is randomized and can start in week 3, 15, 27, 39.)
- Pain coping(From baseline until the end of the study at week 52, measured every ten weeks.)
- Weight(From baseline until the end of the study at week 52, measured every ten weeks. This outcome is also reported at the start and end of the Weight program (twelve weeks), the timing of the Weight program is randomized and can start in week 3, 15, 27, 39.)
- Physical activity readiness(From baseline until the end of the study at week 52, measured every ten weeks.)
- Sleep quality(From baseline until the end of the study at week 52, measured every ten weeks.)
- Intention(From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.)
- Attitude(From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.)
- Perceived behavioural control(From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.)
- Engagement(From baseline until the end of the study in week 52.)
- Healthcare utilization(From baseline until the end of the study in week 52, measured every four weeks.)
研究者
Martijn F. Pisters, PhD, PT
PhD, Associate Professor, Principal Investigator
UMC Utrecht