Feel4Diabetes-study

Harokopio University

Status: Unknown

Conditions: Obesity; Type 2 Diabetes

Treatments: Behavioral: Feel4Diabetes-intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02393872

643708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,000 estimated patients

Sex: All

Ages: 6 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,000 participants in 3 patient groups

High-risk families component

Experimental group

Description:

School-based intervention and counselling sessions.

Treatment:

Behavioral: Feel4Diabetes-intervention

All-families component

Experimental group

Description:

School-based intervention.

Treatment:

Behavioral: Feel4Diabetes-intervention

Control

No Intervention group

Description:

Control group.