Feel4Diabetes-study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Feel4Diabetes-intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-risk families component<br>School-based intervention and counselling sessions. | Behavioral: Feel4Diabetes-intervention<br>* Community-based intervention.<br>|
| Experimental: All-families component<br>School-based intervention. | Behavioral: Feel4Diabetes-intervention<br>* Community-based intervention.<br>|
| No Intervention: Control<br>Control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention