Lifestyle-related Early Detection and Intervention for Older Adults & Elderly at Risk for Metabolic Syndrome: GATEKEEPER
试验速览
- 阶段
- 不适用
- 入组人数
- 960
- 试验地点
- 2
- 主要终点
- Change in Waist circumference (cm) from baseline to 3 months
研究概览
简要总结
In GATEKEEPER intervention, Big Data Analytics techniques will be exploited to address risk stratification and early detection, based on lifestyles analysis including: pattern recognition for the improvement of public health surveillance and for the early detection of chronic conditions; data mining for inductive reasoning and exploratory data analysis; Cluster Analysis for identifying high-risk groups among elder citizens. In the above cases timely intervention is provided by through AI-based, digital coaches, structured conversations, consultation and education. The main target group (N=960) is older adults and elderly citizens with risk factors for MetS and their carers. Therefore, the GATEKEEPER intervention aims at primary (avoid occurrence of disease) and secondary (early detection and management) prevention of the ageing population at risk for MetS.
详细描述
Over 1.5 billion people worldwide are affected by Metabolic Syndrome (MetS) - a cluster of conditions reflecting behavioural risk factors typical of modern lifestyle (excessive food intake, low physical activity, etc) - with a huge socioeconomic impact and a total estimated cost of trillions of euros.
Early prevention measures especially for elderly at high risk of chronic conditions, such as prediabetics or obese, include structured lifestyle change programs that help people achieve and sustain changes in dietary and physical activity habits.
It is well established that MetS prevalence, as well as its individual components (high blood pressure, high glucose, central adiposity) increase with age. Notably, MetS percentages in the age group 50-55 years old and older is almost 2-3 times higher than in the younger age groups, probably due to a life time accumulation of adversities including overnutrition, a sedentary lifestyle, obesity and dyslipidemia, changes in the hormones, untreated hypertension, changes of the functioning of beta cells and other environmental and physiological factors.
Therefore, it is important to target not only elderly citizens, but rather older adults aged ≥55 years old as the optimum target group for a MetS prevention intervention.
In GATEKEEPER intervention, Big Data Analytics techniques will be exploited to address risk stratification and early detection, based on lifestyles analysis including: pattern recognition for the improvement of public health surveillance and for the early detection of chronic conditions; data mining for inductive reasoning and exploratory data analysis; Cluster Analysis for identifying high-risk groups among elder citizens. In the above cases timely intervention is provided by through AI-based, digital coaches, structured conversations, consultation and education. The main target group (N=960) is older adults and elderly citizens with risk factors for MetS and their carers. Therefore, the GATEKEEPER intervention aims at primary (avoid occurrence of disease) and secondary (early detection and management) prevention of the ageing population at risk for MetS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged ≥55 years old
- •Having any of the following risk factors for MetS:
- •waist circumference >94 cm for men and >80 cm for women
- •Triglycerides (TG) ≥150 mg/dL
- •High-density lipoprotein cholesterol (HDL-C) <40 mg/dL for men and <50 mg/dL for women
- •Fasting glucose ≥100 mg/dL
- •Blood pressure ≥130 /≥85 mm Hg
- •Living at home (either alone or with relatives)
- •Informed consent form provided
排除标准
- •Having severe hearing or vision problems or any other acute or chronic condition that would limit the ability of the user to participate in the study
- •Having dementia or cognitive impairment
- •Being institutionalised
- •Participation in another research project
研究组 & 干预措施
Control group (Standard care)
Participants in the control group will receive only the standard care as provided by the local and national healthcare system as well as one face-to-face counselling session for lifestyle modification to improve their risk factors for 3 months.
干预措施: Standard care (Behavioral)
Intervention group 1 (Application)
Participants will will be additionally provided with a health-promotion application for self-management for 3 months.
干预措施: Health-promotion application for self-management (Behavioral)
Intervention group 2 (Devices)
Participants will be additionally provided with wearables and devices for 3 months including:
- A weighing scale (assessing also body composition) device
- A smartwatch/wristband to assess physical activity but also sleep pattern.
干预措施: Wearables and devices (Device)
结局指标
主要结局
Change in Waist circumference (cm) from baseline to 3 months
时间窗: baseline and monthly until 3-month follow-up
Participants' waist circumference will be measured in triplicates (in cm) at baseline and at the 3rd month follow-up visit.
次要结局
- Changes in body mass index (kg/m2) from baseline to 3 months(baseline and monthly until 3-month follow-up)
- Patient-reported outcome measures (PROMs)(baseline and 3 months)
- Changes in Diet quality on FFQ and healthy diet score from baseline to 3 months(baseline and 3 months)
- Changes in sedentary time on validated questionnaires from baseline to 3 months(baseline and 3 months)
- Changes in percentage of body fat from baseline to 3 months(baseline and monthly until 3-month follow-up)
- Changes in Quality of life on EQ5D (Generic HRQL) from baseline to 3 months(baseline and 3 months)
- Changes in Physical activity on validated questionnaires from baseline to 3 months(baseline and 3 months)
- Changes in Sleep duration/quality on Athens Insomnia Scale questionnaire from baseline to 3 months(baseline and 3 months)
研究者
Yannis Manios
Professor
Harokopio University