ObesityFeel4DiabetesNCT02393872
Feel4Diabetes-study
A study testing Feel4Diabetes-intervention in people with Obesity and Type 2 Diabetes, run by Harokopio University at 1 site in Greece.
Trial summary
The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups… Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Feel4Diabetes-intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2016to Aug 2019
- 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 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For children and their parents: low socioeconomic areas and/or vulnerable subgroups of population
- For children: first two grades of compulsory education.
Who cannot join
- Age range not within the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Harokopio University of Athens
Kallithea, Attica, 17671
Yannis Manios, PhD, +302109549156, manios.toybox@hua.gr
About this study
Official title: Developing and Implementing a Community-based Intervention to Create a More Supportive Social and Physical Environment for Lifestyle Changes to Prevent Diabetes in Vulnerable Families Across Europe.
The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe.
Read the detailed description
The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe.
The Feel4Diabetes-intervention will be developed according to the results of systematic literature reviews, narrative reviews and surveys regarding existing research programs, legislation and policies as well as infrastructures, facilities and human resources, which will be conducted during the first phase of the project. It will be implemented in six Eurepean countries, namely Belgium, Bulgaria, Finland, Greece, Hungary and Spain. The process, impact, outcome, cost-effectiveness and scalability of the Feel4Diabetes-intervention will be evaluated and the results of the study will be disseminated via various communication channels.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Feel4Diabetes-intervention
- Keywords
- Prevention
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feel4Diabetes-interventionBehavioural
Community-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| High-risk families component | Experimental | School-based intervention and counselling sessions. Receives: Behavioral: Feel4Diabetes-intervention |
| All-families component | Experimental | School-based intervention. Receives: Behavioral: Feel4Diabetes-intervention |
| Control | No intervention | Control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2018 (estimated)
- Study completionAug 2019 (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 ObesityStudies 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
- Masking
- None (open label)
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, University Ghent, Technische Universität Dresden, National and Kapodistrian University of Athens, International Diabetes Federation, Universidad de Zaragoza, Medical University of Varna, University of Debrecen, Extensive Life Oy
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393872
- Sponsor's protocol ID
- 643708
- Acronym
- Feel4Diabetes
- Status last verified
- Feb 2016
- First submitted
- 16 Mar 2015
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahmood L, Masip G, Moreno LA, Schwarz P, Roth L, Bretschneider M, Willems R, Cardon G, Iotova V, Usheva N, Tankova T, Karaglani E, Manios Y, Gonzalez-Gil EM; Feel4Diabetes-Study Group13. The temporal relationship among socioeconomic vulnerability, dietary intake, and childhood obesity across six European countries: longitudinal results from the Feel4Diabetes-study. Eur J Pediatr. 2026 Sep 16;185(10):753. doi: 10.1007/s00431-026-07415-2.
PubMed 42747589Mahmood L, Moreno LA, Schwarz P, Annemans L, Cardon G, Hilal S, Rurik I, Iotova V, Usheva N, Tankova T, Anastasiou C, Manios Y, Gonzalez-Gil EM; Feel4Diabetes-Study Group. Socioeconomic Vulnerability and Its Associations With Dietary Patterns and Obesity Degree Among Children in Families Across Six European Countries: The Feel4Diabetes-Study. Pediatr Obes. 2026 Jan;21(1):e70072. doi: 10.1111/ijpo.70072.
PubMed 41558509Mahmood L, Moreno LA, Schwarz P, Willems R, Cardon G, Hilal S, Rurik I, Iotova V, Bazdarska Y, Dimova R, Anastasiou K, Manios Y, Gonzalez-Gil EM; Feel4Diabetes-Study Group. A snapshot of country-specific dietary habits and obesity in European children: the Feel4Diabetes study. Eur J Pediatr. 2025 Feb 27;184(3):214. doi: 10.1007/s00431-025-06037-4.
PubMed 40016587Reppas K, Papamichael MM, Usheva N, Iotova V, Chakarova N, Cardon G, Rurik I, Antal E, Valve P, Liatis S, Makrilakis K, Moreno L, Manios Y, Moschonis G. Associations between household food environment and daily intake of regular and diet soft drinks per BMI status of European children: Feel4Diabetes Study. Nutr Bull. 2024 Mar;49(1):82-95. doi: 10.1111/nbu.12659. Epub 2024 Jan 30.
PubMed 38288678Cardon G, Chastin S, Van Stappen V, Huys N, Stefanova T, Chakarova N, Kivela J, Alberto Moreno L, Sandor Istvanne R, Androutsos O, Manios Y, De Craemer M. The Feel4Diabetes intervention: effectiveness on 24-hour physical behaviour composition in families at risk for diabetes development. Health Promot Int. 2022 Oct 1;37(5):daac092. doi: 10.1093/heapro/daac092.
PubMed 36287523Kontochristopoulou AM, Karatzi K, Karaglani E, Cardon G, Kivela J, Wikstrom K, Iotova V, Tsochev K, Tankova T, Rurik I, Radone AS, Liatis S, Makrilakis K, Moreno LA, Manios Y. Sociodemographic, anthropometric, and lifestyle correlates of prediabetes and type 2 diabetes in europe: The Feel4Diabetes study. Nutr Metab Cardiovasc Dis. 2022 Aug;32(8):1851-1862. doi: 10.1016/j.numecd.2022.03.021. Epub 2022 Apr 2.
PubMed 35610084Mahmood L, Gonzalez-Gil EM, Schwarz P, Herrmann S, Karaglani E, Cardon G, De Vylder F, Willems R, Makrilakis K, Liatis S, Iotova V, Tsochev K, Tankova T, Rurik I, Rado S, Moreno LA, Manios Y; Feel4Diabetes-Study Group. Frequency of family meals and food consumption in families at high risk of type 2 diabetes: the Feel4Diabetes-study. Eur J Pediatr. 2022 Jun;181(6):2523-2534. doi: 10.1007/s00431-022-04445-4. Epub 2022 Mar 30.
PubMed 35353229Willems R, Tsoutsoulopoulou K, Brondeel R, Cardon G, Makrilakis K, Liatis S, Lindstrom J, Kivela J, Gonzalez-Gil EM, Gimenez-Legarre N, Usheva N, Iotova V, Tankova T, Antal E, Rurik I, Timpel P, Schwarz PEH, Manios Y, Annemans L. Cost-effectiveness analysis of a school- and community-based intervention to promote a healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: the Feel4Diabetes-study. Prev Med. 2021 Dec;153:106722. doi: 10.1016/j.ypmed.2021.106722. Epub 2021 Jul 14.
PubMed 34271077Huys N, Van Stappen V, Shadid S, De Craemer M, Androutsos O, Wikstrom K, Makrilakis K, Moreno LA, Iotova V, Tankova T, Nanasi A, Manios Y, Cardon G; Feel4Diabetes-study group. Effectiveness of a family-, school- and community-based intervention on physical activity and its correlates in Belgian families with an increased risk for type 2 diabetes mellitus: the Feel4Diabetes-study. BMC Public Health. 2020 Aug 12;20(1):1231. doi: 10.1186/s12889-020-09336-7.
PubMed 32787943Manios Y, Lambrinou CP, Mavrogianni C, Cardon G, Lindstrom J, Iotova V, Tankova T, Rurik I, Stappen VV, Kivela J, Mateo-Gallego R, Moreno LAlpha, Makrilakis K, Androutsos O. Lifestyle Changes Observed among Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe: The 1st Year Results of the Feel4Diabetes-Study. Nutrients. 2020 Jun 30;12(7):1949. doi: 10.3390/nu12071949.
PubMed 32629949Virtanen E, Kivela J, Wikstrom K, Lambrinou CP, De Miguel-Etayo P, Huys N, Vrauko-Toth K, Moreno LA, Usheva N, Chakarova N, Rado SA, Iotova V, Makrilakis K, Cardon G, Liatis S, Manios Y, Lindstrom J; Feel4Diabetes research group. Feel4Diabetes healthy diet score: development and evaluation of clinical validity. BMC Endocr Disord. 2020 May 6;20(Suppl 2):46. doi: 10.1186/s12902-020-0521-x.
PubMed 32370805Androutsos O, Anastasiou C, Lambrinou CP, Mavrogianni C, Cardon G, Van Stappen V, Kivela J, Wikstrom K, Moreno LA, Iotova V, Tsochev K, Chakarova N, Ungvari T, Jancso Z, Makrilakis K, Manios Y; Feel4diabetes-study group. Intra- and inter- observer reliability of anthropometric measurements and blood pressure in primary schoolchildren and adults: the Feel4Diabetes-study. BMC Endocr Disord. 2020 Mar 12;20(Suppl 1):27. doi: 10.1186/s12902-020-0501-1.
PubMed 32164691Kivela J, Wikstrom K, Virtanen E, Georgoulis M, Cardon G, Civeira F, Iotova V, Karuranga E, Ko W, Liatis S, Makrilakis K, Manios Y, Mateo-Gallego R, Nanasi A, Rurik I, Tankova T, Tsochev K, Van Stappen V, Lindstrom J; Feel4Diabetes research group. Obtaining evidence base for the development of Feel4Diabetes intervention to prevent type 2 diabetes - a narrative literature review. BMC Endocr Disord. 2020 Mar 12;20(Suppl 1):140. doi: 10.1186/s12902-019-0468-y.
PubMed 32164690Manios Y, Mavrogianni C, Lambrinou CP, Cardon G, Lindstrom J, Iotova V, Tankova T, Civeira F, Kivela J, Jancso Z, Shadid S, Tsochev K, Mateo-Gallego R, Rado S, Dafoulas G, Makrilakis K, Androutsos O; Feel4Diabetes-study group. Two-stage, school and community-based population screening successfully identifies individuals and families at high-risk for type 2 diabetes: the Feel4Diabetes-study. BMC Endocr Disord. 2020 Mar 12;20(Suppl 1):12. doi: 10.1186/s12902-019-0478-9.
PubMed 32164646Huys N, Van Stappen V, Shadid S, De Craemer M, Androutsos O, Lindstrom J, Makrilakis K, de Sabata MS, Moreno L, De Miguel-Etayo P, Iotova V, Rurik I, Manios Y, Cardon G; Feel4Diabetes-Study Group. Influence of Educational Level on Psychosocial Correlates and Perceived Environmental Correlates of Physical Activity in Adults at Risk for Type 2 Diabetes: The Feel4Diabetes-Study. J Phys Act Health. 2019 Dec 1;16(12):1105-1112. doi: 10.1123/jpah.2019-0003. Epub 2019 Oct 31.
PubMed 31672925
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing a Community-based Intervention to Create a More Supportive Social and Physical Environment for Lifestyle Changes to Prevent Diabetes in Vulnerable Families Across Europe.
- ClinicalTrials.gov ID
- NCT02393872
- Acronym / sponsor ID
- Feel4Diabetes / 643708
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, University Ghent, Technische Universität Dresden, National and Kapodistrian University of Athens, International Diabetes Federation, Universidad de Zaragoza, Medical University of Varna, University of Debrecen, Extensive Life Oy
- Study start
- Jan 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 Mar 2015 (estimated)
- 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.
The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe.
Detailed description
The aim of the Feel4Diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe.
The Feel4Diabetes-intervention will be developed according to the results of systematic literature reviews, narrative reviews and surveys regarding existing research programs, legislation and policies as well as infrastructures, facilities and human resources, which will be conducted during the first phase of the project. It will be implemented in six Eurepean countries, namely Belgium, Bulgaria, Finland, Greece, Hungary and Spain. The process, impact, outcome, cost-effectiveness and scalability of the Feel4Diabetes-intervention will be evaluated and the results of the study will be disseminated via various communication channels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-risk families component | Experimental | Behavioral: Feel4Diabetes-interventionSchool-based intervention and counselling sessions. |
| All-families component | Experimental | Behavioral: Feel4Diabetes-interventionSchool-based intervention. |
| Control | No intervention | –Control group. |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- For children and their parents: low socioeconomic areas and/or vulnerable subgroups of population
- For children: first two grades of compulsory education.
Key exclusion criteria (1 listed)
- Age range not within the inclusion criteria.
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 |
|---|---|---|
| Feel4Diabetes-interventionCommunity-based intervention. | Behavioural | All-families component, High-risk families component |
Primary outcome
Body mass index (BMI)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Derived from this study: PubMed 42747589Mahmood L, Masip G, Moreno LA, Schwarz P, Roth L, Bretschneider M, Willems R, Cardon G, Iotova V, Usheva N, Tankova T, Karaglani E, Manios Y, Gonzalez-Gil EM; Feel4Diabetes-Study Group13. The temporal relationship among socioeconomic vulnerability, dietary intake, and childhood obesity across six European countries: longitudinal results from the Feel4Diabetes-study. Eur J Pediatr. 2026 Sep 16;185(10):753. doi: 10.1007/s00431-026-07415-2.
- Derived from this study: PubMed 41558509Mahmood L, Moreno LA, Schwarz P, Annemans L, Cardon G, Hilal S, Rurik I, Iotova V, Usheva N, Tankova T, Anastasiou C, Manios Y, Gonzalez-Gil EM; Feel4Diabetes-Study Group. Socioeconomic Vulnerability and Its Associations With Dietary Patterns and Obesity Degree Among Children in Families Across Six European Countries: The Feel4Diabetes-Study. Pediatr Obes. 2026 Jan;21(1):e70072. doi: 10.1111/ijpo.70072.
- Derived from this study: PubMed 40016587Mahmood L, Moreno LA, Schwarz P, Willems R, Cardon G, Hilal S, Rurik I, Iotova V, Bazdarska Y, Dimova R, Anastasiou K, Manios Y, Gonzalez-Gil EM; Feel4Diabetes-Study Group. A snapshot of country-specific dietary habits and obesity in European children: the Feel4Diabetes study. Eur J Pediatr. 2025 Feb 27;184(3):214. doi: 10.1007/s00431-025-06037-4.
- Derived from this study: PubMed 38288678Reppas K, Papamichael MM, Usheva N, Iotova V, Chakarova N, Cardon G, Rurik I, Antal E, Valve P, Liatis S, Makrilakis K, Moreno L, Manios Y, Moschonis G. Associations between household food environment and daily intake of regular and diet soft drinks per BMI status of European children: Feel4Diabetes Study. Nutr Bull. 2024 Mar;49(1):82-95. doi: 10.1111/nbu.12659. Epub 2024 Jan 30.
- Derived from this study: PubMed 36287523Cardon G, Chastin S, Van Stappen V, Huys N, Stefanova T, Chakarova N, Kivela J, Alberto Moreno L, Sandor Istvanne R, Androutsos O, Manios Y, De Craemer M. The Feel4Diabetes intervention: effectiveness on 24-hour physical behaviour composition in families at risk for diabetes development. Health Promot Int. 2022 Oct 1;37(5):daac092. doi: 10.1093/heapro/daac092.
- Derived from this study: PubMed 35610084Kontochristopoulou AM, Karatzi K, Karaglani E, Cardon G, Kivela J, Wikstrom K, Iotova V, Tsochev K, Tankova T, Rurik I, Radone AS, Liatis S, Makrilakis K, Moreno LA, Manios Y. Sociodemographic, anthropometric, and lifestyle correlates of prediabetes and type 2 diabetes in europe: The Feel4Diabetes study. Nutr Metab Cardiovasc Dis. 2022 Aug;32(8):1851-1862. doi: 10.1016/j.numecd.2022.03.021. Epub 2022 Apr 2.
- Derived from this study: PubMed 35353229Mahmood L, Gonzalez-Gil EM, Schwarz P, Herrmann S, Karaglani E, Cardon G, De Vylder F, Willems R, Makrilakis K, Liatis S, Iotova V, Tsochev K, Tankova T, Rurik I, Rado S, Moreno LA, Manios Y; Feel4Diabetes-Study Group. Frequency of family meals and food consumption in families at high risk of type 2 diabetes: the Feel4Diabetes-study. Eur J Pediatr. 2022 Jun;181(6):2523-2534. doi: 10.1007/s00431-022-04445-4. Epub 2022 Mar 30.
- Derived from this study: PubMed 34271077Willems R, Tsoutsoulopoulou K, Brondeel R, Cardon G, Makrilakis K, Liatis S, Lindstrom J, Kivela J, Gonzalez-Gil EM, Gimenez-Legarre N, Usheva N, Iotova V, Tankova T, Antal E, Rurik I, Timpel P, Schwarz PEH, Manios Y, Annemans L. Cost-effectiveness analysis of a school- and community-based intervention to promote a healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: the Feel4Diabetes-study. Prev Med. 2021 Dec;153:106722. doi: 10.1016/j.ypmed.2021.106722. Epub 2021 Jul 14.
- Derived from this study: PubMed 32787943Huys N, Van Stappen V, Shadid S, De Craemer M, Androutsos O, Wikstrom K, Makrilakis K, Moreno LA, Iotova V, Tankova T, Nanasi A, Manios Y, Cardon G; Feel4Diabetes-study group. Effectiveness of a family-, school- and community-based intervention on physical activity and its correlates in Belgian families with an increased risk for type 2 diabetes mellitus: the Feel4Diabetes-study. BMC Public Health. 2020 Aug 12;20(1):1231. doi: 10.1186/s12889-020-09336-7.
- Derived from this study: PubMed 32629949Manios Y, Lambrinou CP, Mavrogianni C, Cardon G, Lindstrom J, Iotova V, Tankova T, Rurik I, Stappen VV, Kivela J, Mateo-Gallego R, Moreno LAlpha, Makrilakis K, Androutsos O. Lifestyle Changes Observed among Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe: The 1st Year Results of the Feel4Diabetes-Study. Nutrients. 2020 Jun 30;12(7):1949. doi: 10.3390/nu12071949.
- Derived from this study: PubMed 32370805Virtanen E, Kivela J, Wikstrom K, Lambrinou CP, De Miguel-Etayo P, Huys N, Vrauko-Toth K, Moreno LA, Usheva N, Chakarova N, Rado SA, Iotova V, Makrilakis K, Cardon G, Liatis S, Manios Y, Lindstrom J; Feel4Diabetes research group. Feel4Diabetes healthy diet score: development and evaluation of clinical validity. BMC Endocr Disord. 2020 May 6;20(Suppl 2):46. doi: 10.1186/s12902-020-0521-x.
- Derived from this study: PubMed 32164691Androutsos O, Anastasiou C, Lambrinou CP, Mavrogianni C, Cardon G, Van Stappen V, Kivela J, Wikstrom K, Moreno LA, Iotova V, Tsochev K, Chakarova N, Ungvari T, Jancso Z, Makrilakis K, Manios Y; Feel4diabetes-study group. Intra- and inter- observer reliability of anthropometric measurements and blood pressure in primary schoolchildren and adults: the Feel4Diabetes-study. BMC Endocr Disord. 2020 Mar 12;20(Suppl 1):27. doi: 10.1186/s12902-020-0501-1.
Related trials for Obesity
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of Exercise Training on Breastmilk Composition
Obesity
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feel4Diabetes-intervention in people with Obesity and Type 2 Diabetes, run by Harokopio University at 1 site 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 2 inclusion and 1 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) (time frame: 1 year). 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 NCT02393872, 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 22 Feb 2016; AzTrials last refreshed its copy on 27 Oct 2026.