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

NCT05031299 | Unknown

• 2 other identifiers: 488857223
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; lifestyle intervention; prevention; digital tools; elderly; older adults

Outcome Measures

Primary Outcomes (1)

• Change in Waist circumference (cm) from baseline to 3 months

  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 Outcomes (8)

• Changes in body mass index (kg/m2) from baseline to 3 months

  baseline and monthly until 3-month follow-up

• Changes in percentage of body fat 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 Quality of life on EQ5D (Generic HRQL) from baseline to 3 months

  baseline and 3 months

Study Arms (3)

Control group (Standard care)

ACTIVE COMPARATOR

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

Intervention group 1 (Application)

EXPERIMENTAL

Participants will will be additionally provided with a health-promotion application for self-management for 3 months.

Behavioral: Health-promotion application for self-management

Intervention group 2 (Devices)

EXPERIMENTAL

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

Interventions

Standard care BEHAVIORAL

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.

Control group (Standard care)

Health-promotion application for self-management BEHAVIORAL

Participants will be provided with a health-promotion application for self-management for 3 months, additionally to the standard care.

Intervention group 1 (Application)

Wearables and devices DEVICE

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.

Intervention group 2 (Devices)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead
• CitiesNet: collaborator
• University of Thessaly: collaborator
• University of Patras: collaborator
• BioAssist: collaborator
• University of Ioannina: collaborator
• Centre for Research & Technology Hellas (CERTH): collaborator

Study Sites (2)

Harokopio University of Athens

Kallithea, Attica, 17671, Greece

RECRUITING

University of Thessaly

Trikala, 42132, Greece

RECRUITING

Related Publications (14)

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  PMID: 16371194 BACKGROUND

• Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.

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  PMID: 25126392 BACKGROUND

• Saklayen MG. The Global Epidemic of the Metabolic Syndrome. Curr Hypertens Rep. 2018 Feb 26;20(2):12. doi: 10.1007/s11906-018-0812-z.

  PMID: 29480368 BACKGROUND

• Lesjak V, Stanojevic-Jerkovic O. Physical Activity, Sedentary Behavior and Substance Use among Adolescents in Slovenian Urban Area. Zdr Varst. 2015 Jun 9;54(3):168-74. doi: 10.1515/sjph-2015-0024. eCollection 2015 Sep.

  PMID: 27646724 BACKGROUND

• Scuteri A, Laurent S, Cucca F, Cockcroft J, Cunha PG, Manas LR, Mattace Raso FU, Muiesan ML, Ryliskyte L, Rietzschel E, Strait J, Vlachopoulos C, Volzke H, Lakatta EG, Nilsson PM; Metabolic Syndrome and Arteries Research (MARE) Consortium. Metabolic syndrome across Europe: different clusters of risk factors. Eur J Prev Cardiol. 2015 Apr;22(4):486-91. doi: 10.1177/2047487314525529. Epub 2014 Mar 19.

  PMID: 24647805 BACKGROUND

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  PMID: 27158519 BACKGROUND

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• Athyros VG, Ganotakis ES, Bathianaki M, Monedas I, Goudevenos IA, Papageorgiou AA, Papathanasiou A, Kakafika AI, Mikhailidis DP, Elisaf M; MetS-Greece Collaborative Group. Awareness, treatment and control of the metabolic syndrome and its components: a multicentre Greek study. Hellenic J Cardiol. 2005 Nov-Dec;46(6):380-6.

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• Park MJ, Kim HS. Evaluation of mobile phone and Internet intervention on waist circumference and blood pressure in post-menopausal women with abdominal obesity. Int J Med Inform. 2012 Jun;81(6):388-94. doi: 10.1016/j.ijmedinf.2011.12.011. Epub 2012 Jan 21.

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• Konerding U, Elkhuizen SG, Faubel R, Forte P, Malmstrom T, Pavi E, Janssen MF. The validity of the EQ-5D-3L items: an investigation with type 2 diabetes patients from six European countries. Health Qual Life Outcomes. 2014 Dec 5;12:181. doi: 10.1186/s12955-014-0181-5.

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MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Standard of Care; Self-Management; Equipment and Supplies

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Odysseas Androutsos, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannis Manios, PhD

CONTACT

+30 210 9549156; manios@hua.gr

Eva Karaglani, PhD-c

CONTACT

+30 210 9549340; ekaragl@hua.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 1, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)