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

Metabolic Syndrome Clinical Trial

— GATEKEEPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031299
• Other study ID #: 488
• Secondary ID: 857223
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Harokopio University
• Contact: Yannis Manios, PhD
• Phone: +30 210 9549156
• Email: manios[@]hua.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Greece	Harokopio University of Athens	Kallithea	Attica
Greece	University of Thessaly	Trikala

Sponsors (7)

Lead Sponsor	Collaborator
Harokopio University	BioAssist, Centre for Research & Technology Hellas (CERTH), CitiesNet, University of Ioannina, University of Patras, University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (14)

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. — View Citation

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. — View Citation

Devers MC, Campbell S, Simmons D. Influence of age on the prevalence and components of the metabolic syndrome and the association with cardiovascular disease. BMJ Open Diabetes Res Care. 2016 Apr 25;4(1):e000195. doi: 10.1136/bmjdrc-2016-000195. eCollection 2016. — View Citation

Kokaliari ED, Roy AW. Validation of the Greek translation of the multicultural quality of life index (MQLI-gr). Health Qual Life Outcomes. 2020 Jun 15;18(1):183. doi: 10.1186/s12955-020-01426-9. — View Citation

Konerding U, Elkhuizen SG, Faubel R, Forte P, Malmström 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. — View Citation

Kraja AT, Borecki IB, North K, Tang W, Myers RH, Hopkins PN, Arnett D, Corbett J, Adelman A, Province MA. Longitudinal and age trends of metabolic syndrome and its risk factors: the Family Heart Study. Nutr Metab (Lond). 2006 Dec 5;3:41. — View Citation

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. — View Citation

Liu D, Maimaitijiang R, Gu J, Zhong S, Zhou M, Wu Z, Luo A, Lu C, Hao Y. Using the Unified Theory of Acceptance and Use of Technology (UTAUT) to Investigate the Intention to Use Physical Activity Apps: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2019 Aug 22;7(9):e13127. doi: 10.2196/13127. — View Citation

Martín-Timón I, Sevillano-Collantes C, Segura-Galindo A, Del Cañizo-Gómez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Scuteri A, Laurent S, Cucca F, Cockcroft J, Cunha PG, Mañas LR, Mattace Raso FU, Muiesan ML, Ryliškyte L, Rietzschel E, Strait J, Vlachopoulos C, Völzke 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. — View Citation

Soldatos CR, Dikeos DG, Paparrigopoulos TJ. Athens Insomnia Scale: validation of an instrument based on ICD-10 criteria. J Psychosom Res. 2000 Jun;48(6):555-60. — View Citation

Zimmet P, M M Alberti KG, Serrano Ríos M. [A new international diabetes federation worldwide definition of the metabolic syndrome: the rationale and the results]. Rev Esp Cardiol. 2005 Dec;58(12):1371-6. Spanish. Erratum in: Rev Esp Cardiol. 2006 Feb;59(2):185. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in body mass index (kg/m2) from baseline to 3 months	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
Secondary	Changes in percentage of body fat from baseline to 3 months	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
Secondary	Patient-reported outcome measures (PROMs)	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
Secondary	Changes in Diet quality on FFQ and healthy diet score from baseline to 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
Secondary	Changes in Quality of life on EQ5D (Generic HRQL) from baseline to 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
Secondary	Changes in Physical activity on validated questionnaires from baseline to 3 months	Physical activity will be assessed via validated questionnaires at baseline and at the 3rd month follow-up visit.	baseline and 3 months
Secondary	Changes in sedentary time on validated questionnaires from baseline to 3 months	Sedentary time will be assessed via validated questionnaires at baseline and at the 3rd month follow-up visit.	baseline and 3 months
Secondary	Changes in Sleep duration/quality on Athens Insomnia Scale questionnaire from baseline to 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