Lifestyle-related Early Detection and Intervention for Older Adults & Elderly at Risk for Metabolic Syndrome (GATEKEEPER)

August 26, 2021 updated by: Yannis Manios, Harokopio University

Lifestyle-related Early Detection and Intervention for Older Adults & Elderly at Risk for Metabolic Syndrome: GATEKEEPER

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

960

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yannis Manios, PhD
  • Phone Number: +30 210 9549156
  • Email: manios@hua.gr

Study Contact Backup

  • Name: Eva Karaglani, PhD-c
  • Phone Number: +30 210 9549340
  • Email: ekaragl@hua.gr

Study Locations

  • Greece
      • Trikala, Greece, 42132
        • Recruiting
        • University of Thessaly
        • Contact:
        • Contact:
    • Attica
      • Kallithea, Attica, Greece, 17671
        • Recruiting
        • Harokopio University of Athens
        • Contact:
          • Eva Karaglani, PhD-c
          • Phone Number: +30 210 9549340
          • Email: ekaragl@hua.gr
        • Contact:
          • Yannis Manios, PhD
          • Phone Number: +30 2109549156
          • Email: manios@hua.gr
        • Principal Investigator:
          • Odysseas Androutsos, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Standard care
Participants 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.
Experimental: Intervention group 1 (Application)
Participants will will be additionally provided with a health-promotion application for self-management for 3 months.
Behavioral: Health-promotion application for self-management
Participants will be provided with a health-promotion application for self-management for 3 months, additionally to the standard care.
Experimental: 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.
Device: Wearables and devices
Participants will be provided with wearables and devices, including a weighing scale (assessing also body composition) device and a smartwatch/wristband to assess physical activity but also sleep pattern, for 3 months, additionally to the standard care and the Health-promotion application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Waist circumference (cm) from baseline to 3 months
Time Frame: 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.
baseline and monthly until 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body mass index (kg/m2) from baseline to 3 months
Time Frame: baseline and monthly until 3-month follow-up
Participants' BMI will be measured in triplicates (in kg/m2) at baseline and at the 3rd month follow-up visit.
baseline and monthly until 3-month follow-up
Changes in percentage of body fat from baseline to 3 months
Time Frame: baseline and monthly until 3-month follow-up
Participants' percentage of body fat will be measured at baseline and at the 3rd month follow-up visit.
baseline and monthly until 3-month follow-up
Patient-reported outcome measures (PROMs)
Time Frame: baseline and 3 months
Patient-reported outcome measures (PROMs), including satisfaction of the intervention at baseline and at the 3rd month follow-up visit. Satisfaction of the intervention will be measured via the UTAUT questionnaire [Liu D et al. 2019] or other validated questionnaire.
baseline and 3 months
Changes in Diet quality on FFQ and healthy diet score from baseline to 3 months
Time Frame: baseline and 3 months
Diet quality will be assessed via the food-frequency questionnaire (FFQ) and the healthy diet score developed and validated in the EU-funded Feel4Diabetes-study (www.feel4diabetes-study.eu) or other validated questionnaires at baseline and at the 3rd month follow-up visit.
baseline and 3 months
Changes in Quality of life on EQ5D (Generic HRQL) from baseline to 3 months
Time Frame: baseline and 3 months
Quality of life will be assessed via the EQ5D (Generic HRQL) [Konerding U et al. 2014] at baseline and at the 3rd month follow-up visit.
baseline and 3 months
Changes in Physical activity on validated questionnaires from baseline to 3 months
Time Frame: baseline and 3 months
Physical activity will be assessed via validated questionnaires at baseline and at the 3rd month follow-up visit.
baseline and 3 months
Changes in sedentary time on validated questionnaires from baseline to 3 months
Time Frame: baseline and 3 months
Sedentary time will be assessed via validated questionnaires at baseline and at the 3rd month follow-up visit.
baseline and 3 months
Changes in Sleep duration/quality on Athens Insomnia Scale questionnaire from baseline to 3 months
Time Frame: baseline and 3 months
Sleep duration and sleep quality will be assessed via the Athens Insomnia Scale questionnaire [Soldatos CR et al. 2000] or other validated questionnaires at baseline and at the 3rd month follow-up visit.
baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

University of Thessaly
University of Ioannina
University of Patras
CitiesNet
BioAssist
Centre for Research & Technology Hellas (CERTH)

Investigators

  • Principal Investigator: Odysseas Androutsos, PhD, University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 488
  • 857223 (Other Grant/Funding Number: European Union Horizon 2020 research & innovation programme)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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