# Multidisciplinary lifestyle treatment for type 2 diabetes in 12 European countries: protocol for a quasi-experimental study

## TL;DR

This study evaluates a lifestyle program to manage type 2 diabetes across 12 European countries, focusing on its effectiveness and cost.

## Contribution

The study introduces a multidisciplinary lifestyle program for type 2 diabetes across multiple European regions.

## Key findings

- The program involves 860 participants and healthcare professionals across 12 countries.
- It includes an intensive 6-month phase and a 6-month aftercare phase for behavioral change.
- Impact, sustainability, and cost-effectiveness will be evaluated using validated questionnaires.

## Abstract

The incidence and prevalence of type 2 diabetes (T2DM) are expected to continue rising. T2DM causes life-threatening, disabling and costly complications, and significantly reduces quality of life and life expectancy. The burden of T2DM can be reduced using comprehensive lifestyle modifications. The aim of this study is to evaluate the applicability and cost-effectiveness of a multicomponent, multidisciplinary lifestyle program in 22 European regions and to generate guidelines for transfer to European health care systems.

A quasi-experimental study (without a control group) will be conducted to evaluate the CARE4DIABETES program, which is based on the Reverse Diabetes 2Now best practice. The program will involve more than 120 healthcare professionals and 860 people with T2DM from 12 European countries - Belgium, Bulgaria, Finland, Hungary, Italy, Greece, Malta, Poland, Portugal, Slovakia, Slovenia and Spain. Patients will be enrolled based on clinical criteria and motivation for change. The program will have two phases, an intensive phase (6 months) with face-to-face and online training to achieve behavioral change, and an online aftercare phase (6 months) to consolidate changes. The program will be evaluated for impact, sustainability and cost-effectiveness using a combination of validated questionnaires at baseline, six months and one year after the start of the intervention.

Trial registration number: ISRCTN62063346.