DIGITALIZATION OF PERSONALISED HEALTH RISK MANAGEMENT IN AT-RISK GROUPS TO IMPROVE HEALTH OUTCOMES THROUGH INTEGRATION OF TECHNOLOGICAL AND SOCIAL INNOVATION
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Rate of wearable adoption/use
研究概览
简要总结
The principal objective of the project is:
- to bring together academic and business research organisations in a joint partnership integrating technological and social innovation,
- in order to develop proof-of-concept of a scalable and cost effective personalised digital health program for (pre)obesity patients,
- by integrating, in an ethical manner, adaptive AI components aimed at personalisation of the program as well as its cost management,
- with the ultimate objective to support sustained behavioural change leading to adoption and internalisation of healthy lifestyle choices.
详细描述
This research project is aimed at leveraging digital tools to personalise preventive healthcare interventions for at-risk populations in ways that address the above-mentioned challenges. At risk populations, in the context of this project, generally means: Younger to middle aged (aged 30-50) sedentary individuals with (pre)obesity expressing behavioural, clinical, biochemical and anamnestic indicators of increased risk for accelerated decline of cardio-metabolic and cognitive health.
Primary outcomes will be the rate of wearable adoption/use, individualised behavioural change persistence and elicited health benefit
Secondary outcomes will include step count, activity of medium & vigorous intensity, sleep duration/efficiency, heart rate, quality of life, body weight, body composition, blood pressure, and level of fitness as determined by the wearable or validated questionaires available on the landing page.
Participants will be randomly assigned into one of the three intervention groups and a control group. The three intervention groups:
- Self-health coaching will be conducted using wearable and technology provided nudges allowing personalised technology-assisted real-time feedback. With this approach, on-line intervention with minimal human resource costs and high technology involvement with a potential to deliver sustainable and cost-effective behavioural change to a large at-risk population will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obesity (BMI 27-42 kg/m²)
- •capacity and willingness to use smartphone
- •capacity and willingness to use wearables
- •readiness to change (validated questionaire)
排除标准
- •diseases that prevent participation in the program, or insufficiently controlled diseases, or terminal-stage illnesses
- •excessive alcohol consumption or a history of other addictions
- •patients currently participating in a weight-loss program (commercial, medically supervised, or a research study)
- •patients using anti-obesity medications who are in the dosage adjustment phase within the last four weeks
- •patients who are not mentally, physically, or technologically capable of participating
- •patients who are unable to provide informed consent
- •patients not adhering to the study protocol
结局指标
主要结局
Rate of wearable adoption/use
时间窗: 24 months
Rate of wearable adoption/use will be determenrd from the wearable allowed data in-flow.
Effect of intervention on Quality of life
时间窗: 24 months
Quality of life will be provided by the validated questionaire filled in at baseline and after completing the study.
Effect of intervention on health
时间窗: 24 months
Effects of intervention for health state will be provided by the questionaire administered at the baseline and after completing the study.
次要结局
- Habitual physical activity volume(24 months)
- Sleep quality(24 months)
- Activity-related energy expenditure(24 months)
- Stress level(24 months)
研究者
Jozef Ukropec
PhD, DSc
Slovak Academy of Sciences