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Feel4Diabetes-study (Feel4Diabetes)

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ClinicalTrials.gov Identifier: NCT02393872
Recruitment Status : Unknown
Verified February 2016 by Yannis Manios, Harokopio University.
Recruitment status was:  Recruiting
First Posted : March 20, 2015
Last Update Posted : February 22, 2016
Sponsor:
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 Varna
University of Debrecen
Extensive Life Oy
Information provided by (Responsible Party):
Yannis Manios, Harokopio University

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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Behavioral: Feel4Diabetes-intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-risk families component
School-based intervention and counselling sessions.
Behavioral: Feel4Diabetes-intervention
Community-based intervention.

Experimental: All-families component
School-based intervention.
Behavioral: Feel4Diabetes-intervention
Community-based intervention.

No Intervention: Control
Control group.



Primary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age range not within the inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393872


Locations
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Greece
Harokopio University of Athens Recruiting
Kallithea, Attica, Greece, 17671
Contact: Yannis Manios, PhD    +302109549156    manios.toybox@hua.gr   
Sponsors and Collaborators
Harokopio University
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 Varna
University of Debrecen
Extensive Life Oy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yannis Manios, Associate Professor, Harokopio University
ClinicalTrials.gov Identifier: NCT02393872    
Other Study ID Numbers: 643708
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Keywords provided by Yannis Manios, Harokopio University:
Prevention
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases