Clinical trial NCT05031299: Lifestyle-related Early Detection and Intervention for Older Adults & Elderly at Risk for Metabolic Syndrome
Official title: Lifestyle-related Early Detection and Intervention for Older Adults & Elderly at Risk for Metabolic Syndrome: GATEKEEPER
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
lifestyle intervention
prevention
digital tools
elderly
older adults
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: CitiesNet
name: University of Thessaly
name: University of Patras
name: BioAssist
name: University of Ioannina
name: Centre for Research & Technology Hellas (CERTH)
First posted: 2021-09-01
Enrollment: 960
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a cluster-randomized lifestyle intervention aimed at primary and secondary prevention of MetS, including three study arms: standard care (control group), standard care plus lifestyle application (intervention group 1) and standard care plus lifestyle application and wearables and devices (intervention group 2). It is conducted with older adults and elderly (aged ≥55 years old) living at home and at risk for MetS, as well as their carers. The total duration of the intervention for each participant will be 3 months.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

960 older adults and elderly citizens (aged \>=55 years old) with risk factors for MetS as well as their carers (n=40) will be recruited and will be randomized to either: i) the intervention group 1 (n=320), who will be provided with the standard care plus a lifestyle application to promote self-management, increase health literacy and awareness through a digital coach, ii) the intervention group 2 (n=320), who will be provided with the standard care, the lifestyle application and additionally digital tools and wearables, such as a smart tracker and weight scale, or iii) the control group (n=320), who will only receive 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.

The participants will be followed up for a total duration of 3 months, when they will be re-evaluated to assess whether their risk factors were improved through the lifestyle intervention.

The users will be recruited at local community centres, such as the "Open Day Elderly Centres", health centres, private offices of health care professionals, hospitals etc. upon written informed consent form.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Waist circumference (cm) from baseline to 3 months
timeFrame: baseline and monthly until 3-month follow-up
Secondary outcomes:
measure: Changes in body mass index (kg/m2) from baseline to 3 months
timeFrame: baseline and monthly until 3-month follow-up
measure: Changes in percentage of body fat from baseline to 3 months
timeFrame: baseline and monthly until 3-month follow-up
measure: Patient-reported outcome measures (PROMs)
timeFrame: baseline and 3 months
measure: Changes in Diet quality on FFQ and healthy diet score from baseline to 3 months
timeFrame: baseline and 3 months
measure: Changes in Quality of life on EQ5D (Generic HRQL) from baseline to 3 months
timeFrame: baseline and 3 months
measure: Changes in Physical activity on validated questionnaires from baseline to 3 months
timeFrame: baseline and 3 months
measure: Changes in sedentary time on validated questionnaires from baseline to 3 months
timeFrame: baseline and 3 months
measure: Changes in Sleep duration/quality on Athens Insomnia Scale questionnaire from baseline to 3 months
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Kallithea
country: Greece
facility: Harokopio University of Athens
state: Attica
city: Trikala
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Odysseas Androutsos, PhD
role: PRINCIPAL_INVESTIGATOR
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