Feel4Diabetes-study

NCT ID: NCT02393872

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

9000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-08-31

Brief Summary

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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

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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

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Obesity Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High-risk families component

School-based intervention and counselling sessions.

Group Type EXPERIMENTAL

Feel4Diabetes-intervention

Intervention Type BEHAVIORAL

Community-based intervention.

All-families component

School-based intervention.

Group Type EXPERIMENTAL

Feel4Diabetes-intervention

Intervention Type BEHAVIORAL

Community-based intervention.

Control

Control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Feel4Diabetes-intervention

Community-based intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* For children and their parents: low socioeconomic areas and/or vulnerable subgroups of population
* For children: first two grades of compulsory education.
Minimum Eligible Age

6 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

International Diabetes Federation

OTHER

Sponsor Role collaborator

Universidad de Zaragoza

OTHER

Sponsor Role collaborator

Medical University of Varna

OTHER

Sponsor Role collaborator

University of Debrecen

OTHER

Sponsor Role collaborator

Extensive Life Oy

UNKNOWN

Sponsor Role collaborator

Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Yannis Manios

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Harokopio University of Athens

Kallithea, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Facility Contacts

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Yannis Manios, PhD

Role: primary

+302109549156

References

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Mahmood 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.

Reference Type DERIVED
PMID: 40016587 (View on PubMed)

Cardon 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.

Reference Type DERIVED
PMID: 36287523 (View on PubMed)

Kontochristopoulou 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.

Reference Type DERIVED
PMID: 35610084 (View on PubMed)

Mahmood 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.

Reference Type DERIVED
PMID: 35353229 (View on PubMed)

Willems 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.

Reference Type DERIVED
PMID: 34271077 (View on PubMed)

Huys 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.

Reference Type DERIVED
PMID: 32787943 (View on PubMed)

Manios 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.

Reference Type DERIVED
PMID: 32629949 (View on PubMed)

Virtanen 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.

Reference Type DERIVED
PMID: 32370805 (View on PubMed)

Androutsos 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.

Reference Type DERIVED
PMID: 32164691 (View on PubMed)

Kivela 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.

Reference Type DERIVED
PMID: 32164690 (View on PubMed)

Manios 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.

Reference Type DERIVED
PMID: 32164646 (View on PubMed)

Huys 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.

Reference Type DERIVED
PMID: 31672925 (View on PubMed)

Other Identifiers

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643708

Identifier Type: -

Identifier Source: org_study_id

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