|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Obesity Type 2 Diabetes||Behavioral: Feel4Diabetes-intervention||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||9000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: High-risk families component
School-based intervention and counselling sessions.
Experimental: All-families component
No Intervention: Control
- Body mass index (BMI) [ Time Frame: 1 year ]
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
|Harokopio University of Athens||Recruiting|
|Kallithea, Attica, Greece, 17671|
|Contact: Yannis Manios, PhD +302109549156 email@example.com|