NCT02393872

Brief 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 in high income countries in Europe.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

March 16, 2015

Last Update Submit

February 19, 2016

Conditions

ObesityType 2 Diabetes

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

  • Body mass index (BMI)

    1 year

Study Arms (3)

High-risk families component

EXPERIMENTAL

School-based intervention and counselling sessions.

Behavioral: Feel4Diabetes-intervention

All-families component

EXPERIMENTAL

School-based intervention.

Behavioral: Feel4Diabetes-intervention

Control

NO INTERVENTION

Control group.

Interventions

Feel4Diabetes-interventionBEHAVIORAL

Community-based intervention.

All-families componentHigh-risk families component

Eligibility Criteria

Age6 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harokopio University of Athens

Kallithea, Attica, 17671, Greece

RECRUITING

Related Publications (13)

  • Mahmood 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.

    PMID: 41558509DERIVED

  • 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.

    PMID: 40016587DERIVED

  • 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.

    PMID: 36287523DERIVED

  • 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.

    PMID: 35610084DERIVED

  • 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.

    PMID: 35353229DERIVED

  • 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.

    PMID: 34271077DERIVED

  • 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.

    PMID: 32787943DERIVED

  • 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.

    PMID: 32629949DERIVED

  • 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.

    PMID: 32370805DERIVED

  • 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.

    PMID: 32164691DERIVED

  • 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.

    PMID: 32164690DERIVED

  • 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.

    PMID: 32164646DERIVED

  • 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.

    PMID: 31672925DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

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
Associate Professor

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2018

Study Completion

August 1, 2019

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

GR(1)