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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Harokopio University
- Enrollment
- 9,000
- Locations
- 1
- Primary Endpoint
- Body mass index (BMI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
High-risk families component
School-based intervention and counselling sessions.
Intervention: Feel4Diabetes-intervention (Behavioral)
All-families component
School-based intervention.
Intervention: Feel4Diabetes-intervention (Behavioral)
Control
Control group.
Outcomes
Primary Outcomes
Body mass index (BMI)
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Yannis Manios
Associate Professor
Harokopio University