Feel4Diabetes-study (Feel4Diabetes)

February 19, 2016 updated by: Yannis Manios, Harokopio University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

9000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Kallithea, Attica, Greece, 17671
        • Recruiting
        • Harokopio University of Athens
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body mass index (BMI)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

National and Kapodistrian University of Athens
Technische Universität Dresden
University Ghent
Universidad de Zaragoza
Finnish Institute for Health and Welfare
University of Debrecen
International Diabetes Federation
Medical University Varna
Extensive Life Oy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 643708

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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