Feel4Diabetes-study

Obesity Clinical Trial

— Feel4Diabetes  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02393872
• Other study ID #: 643708
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: February 19, 2016
• Start date: January 2016
• Est. completion date: August 2019

Study information

• Verified date: February 2016
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBulgaria: Ethics committeeFinland: Ethics CommitteeGreece: Ethics CommitteeHungary: Ethics CommitteeSpain: Ethics Committee
• Study type: Interventional

Clinical 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 in high income countries in Europe.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: August 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Feel4Diabetes-intervention
Community-based intervention.

Locations

Country	Name	City	State
Greece	Harokopio University of Athens	Kallithea	Attica

Sponsors (10)

Lead Sponsor	Collaborator
Harokopio University	Extensive Life Oy, International Diabetes Federation, Medical University Varna, National and Kapodistrian University of Athens, National Institute for Health and Welfare, Finland, Technische Universität Dresden, Universidad de Zaragoza, University Ghent, University of Debrecen

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index (BMI)		1 year	No