Feel4Diabetes-study

Not Applicable

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Behavioral: Feel4Diabetes-intervention

• Registration Number: NCT02393872
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Study Start: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22
• Primary Completion: 2018-06
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-risk families component	Feel4Diabetes-intervention	School-based intervention and counselling sessions.
All-families component	Feel4Diabetes-intervention	School-based intervention.

Primary Outcome Measures

Name	Time	Method
Body mass index (BMI)	1 year

Trial Locations

Locations (1)

Harokopio University of Athens; 🇬🇷 Kallithea, Attica, Greece