Metabolic SyndromeGATEKEEPERNCT05031299
Lifestyle-related Early Detection and Intervention for Older Adults & Elderly at Risk for Metabolic Syndrome
A study testing Health-promotion application for self-management and Wearables and devices in people with Metabolic Syndrome, run by Harokopio University at 2 sites in Greece.
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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Health-promotion application for self-management and Wearables and devices
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Mar 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Blood pressure ≥130 /≥85 mm Hg
- Living at home (either alone or with relatives)
- Informed consent form provided
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
Harokopio University of Athens
Kallithea, Attica, 17671
Yannis Manios, PhD, +30 2109549156, manios@hua.gr
Eva Karaglani, PhD-c, +30 210 9549340, ekaragl@hua.gr
- Recruiting
University of Thessaly
Trikala, 42132
Odysseas Androutsos, PhD, +30 6944290774, oandroutsos@uth.gr
Maria Vlahava, PhD, +30 6945751020, vlachavamaria@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Standard care, Health-promotion application for self-management, Wearables and devices
- Keywords
- metabolic syndrome, lifestyle intervention, prevention, digital tools, elderly, older adults
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careBehavioural
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-managementBehavioural
Participants will be provided with a health-promotion application for self-management for 3 months, additionally to the standard care.
Wearables and devicesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Wearables and devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and monthly until 3-month follow-up
Secondary outcomes (8)
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.
Measured: baseline and monthly until 3-month follow-up
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.
Measured: baseline and monthly until 3-month follow-up
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.
Measured: baseline and 3 months
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.
Measured: baseline and 3 months
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.
Measured: baseline and 3 months
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.
Measured: baseline and 3 months
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.
Measured: baseline and 3 months
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.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Mar 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- CitiesNet, University of Thessaly, University of Patras, BioAssist, University of Ioannina, Centre for Research and Technology Hellas
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
- Investigators
- Odysseas Androutsos, PhD, Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031299
- Sponsor's protocol ID
- 488
- Other IDs
- 857223
- Acronym
- GATEKEEPER
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zimmet P, M M Alberti KG, Serrano Rios 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. No abstract available. Spanish.
PubMed 16371194Alberti 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.
PubMed 19805654Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez 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.
PubMed 25126392Saklayen MG. The Global Epidemic of the Metabolic Syndrome. Curr Hypertens Rep. 2018 Feb 26;20(2):12. doi: 10.1007/s11906-018-0812-z.
PubMed 29480368Lesjak 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.
PubMed 27646724Scuteri 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.
PubMed 24647805Devers 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.
PubMed 27158519Kraja 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. doi: 10.1186/1743-7075-3-41.
PubMed 17147796Athyros 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.
PubMed 16422124Park 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.
PubMed 22265810Konerding 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.
PubMed 25479769Kokaliari 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.
PubMed 32539776Liu 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.
PubMed 31507269Soldatos 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. doi: 10.1016/s0022-3999(00)00095-7.
PubMed 11033374Makri R, Evangelou I, Karaglani E, Vlachava M, Dafoulas GE, Drympeta I, Votis K, Georga EI, Fotiadis DI, Lupianez-Villanueva F, Folkvord F, Pecchia L, Fico G, Panagiotakos D, Androutsos O, Manios Y; GATEKEEPER study (Greek Use Case 1) group. Impact of Dietetic Counseling Combined With Digital Tools on Obesity-Related Indices in Greek Adults: The GATEKEEPER Study. Obesity (Silver Spring). 2026 Sep 18. doi: 10.1002/oby.70284. Online ahead of print.
PubMed 42759999
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle-related Early Detection and Intervention for Older Adults & Elderly at Risk for Metabolic Syndrome: GATEKEEPER
- ClinicalTrials.gov ID
- NCT05031299
- Acronym / sponsor ID
- GATEKEEPER / 488
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, lifestyle intervention, prevention, digital tools, elderly, older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- CitiesNet, University of Thessaly, University of Patras, BioAssist, University of Ioannina, Centre for Research and Technology Hellas
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group (Standard care) | Active comparator | Behavioral: Standard careParticipants 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. |
| Intervention group 1 (Application) | Experimental | Behavioral: Health-promotion application for self-managementParticipants will will be additionally provided with a health-promotion application for self-management for 3 months. |
| Intervention group 2 (Devices) | Experimental | Device: Wearables and devicesParticipants 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females aged ≥55 years old
- Having any of the following risk factors for MetS:
- Living at home (either alone or with relatives)
- Informed consent form provided
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careParticipants 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. | Behavioural | Control group (Standard care) |
| Health-promotion application for self-managementParticipants will be provided with a health-promotion application for self-management for 3 months, additionally to the standard care. | Behavioural | Intervention group 1 (Application) |
| Wearables and devicesParticipants 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. | Device | Intervention group 2 (Devices) |
Primary outcome
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.
8 secondary outcomes
Changes in body mass index (kg/m2) from baseline to 3 months
Time frame: 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
Patient-reported outcome measures (PROMs)
Time frame: 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
Changes in Quality of life on EQ5D (Generic HRQL) from baseline to 3 months
Time frame: baseline and 3 months
Changes in Physical activity on validated questionnaires from baseline to 3 months
Time frame: baseline and 3 months
Changes in sedentary time on validated questionnaires from baseline to 3 months
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 16371194Zimmet P, M M Alberti KG, Serrano Rios 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. No abstract available. Spanish.
- Background: PubMed 19805654Alberti 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.
- Background: PubMed 25126392Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez 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.
- Background: PubMed 29480368Saklayen MG. The Global Epidemic of the Metabolic Syndrome. Curr Hypertens Rep. 2018 Feb 26;20(2):12. doi: 10.1007/s11906-018-0812-z.
- Background: PubMed 27646724Lesjak 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.
- Background: PubMed 24647805Scuteri 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.
- Background: PubMed 27158519Devers 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.
- Background: PubMed 17147796Kraja 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. doi: 10.1186/1743-7075-3-41.
- Background: PubMed 16422124Athyros 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.
- Background: PubMed 22265810Park 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.
- Background: PubMed 25479769Konerding 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.
- Background: PubMed 32539776Kokaliari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odysseas Androutsos, PhD principal investigator
University of Thessaly
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-promotion application for self-management and Wearables and devices in people with Metabolic Syndrome, run by Harokopio University at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannis Manios, PhD (+30 210 9549156, manios@hua.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Waist circumference (cm) from baseline to 3 months (time frame: baseline and monthly until 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031299, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.