CARE4DIABETES - Reducing the burden of non-communicable diseases by providing a multi-disciplinary lifestyle treatment intervention for type 2 diabetes
| ISRCTN | ISRCTN62063346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62063346 |
| Secondary identifying numbers | EU4H-J2021-JA2-IBA-101082427, GA 101082427 |
- Submission date
- 21/01/2025
- Registration date
- 25/02/2025
- Last edited
- 25/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 Diabetes Mellitus (T2DM) is a major health issue in many countries. The CARE4DIABETES study aims to help EU countries reduce diabetes risk factors through a lifestyle treatment based on a successful Dutch program called Reverse Diabetes2Now.
Who can participate?
Participants must be 20-80 years old, diagnosed with T2DM, taking diabetes medication, and have a BMI of 25-40 kg/m². They should be able to use digital devices and be committed to making lifestyle changes. Participants should not have severe comorbidities like COPD, kidney or heart failure, have had bariatric surgery, have an eating disorder, or be pregnant or planning to become pregnant during the 12-month study period.
What does the study involve?
The study involves an initial 6-month phase where a team of experts works with groups of 20 people with T2DM. Participants receive counseling on nutrition, physical activity, sleep, and stress management, biometric information, and cooking classes. They also use a digital platform for personal advice and medical follow-up on their medication. The next 6 months focus on maintaining these changes.
What are the possible benefits and risks of participating?
Participants may benefit from improved health and better management of their diabetes through lifestyle changes. However, the study does not have a control group, and different cultural contexts in various European settings might affect the results.
Where is the study run from?
The study is conducted in 22 locations across 12 countries: Belgium, Bulgaria, Finland, Greece, Hungary, Italy, Malta, Poland, Portugal, Slovakia, Slovenia, and Spain.
When is the study starting and how long is it expected to run for?
The study started in February 2023 and is expected to run until January 2026.
Who is funding the study?
The study is funded by the European Commission under the EU4H-2021-C4D-08.1 program, Grant Agreement 101082427.
Who is the main contact?
Dr. Marta Maria Pisano González, martamaria.pisanogonzalez@asturias.org
Contact information
Public, Scientific, Principal Investigator
C/Ciriaco Miguel Vigil 9
Oviedo. Asturias
33006
Spain
 ORCID ID |
0000-0002-6485-9370 |
|---|---|
| Phone | +34 696197060 |
| martamaria.pisanogonzalez@asturias.org |
Study information
| Study design | Quasi-experimental prospective multicenter study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Home |
| Study type | Other, Prevention, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | In patients with Type 2 diabetes, how does a multidisciplinary lifestyle intervention compared to other approaches affect patients' well-being and quality of life, reduce healthcare-associated costs, and promote capacity building of health systems towards more innovative and integrated interventions based on lifestyle changes? |
| Study acronym | CARE4DIABETES Joint Action |
| Study objectives | Non-communicable diseases (NCDs), such as type 2 diabetes (T2D), represent major causes of disability, ill-health, health-related retirement, and premature death in the EU and cause a considerable social and economic impact. The European project Care4Diabetes Joint Action (C4D) will foster transfer and implementation of an innovative practice that has the potential to reduce the health burden of T2D by increasing the quality of life and extending life expectancy and decrease the cost of usual T2D management, including medications and/or improve the outcomes for a given investment. |
| Ethics approval(s) |
1. Approved 11/10/2023, Comité De Ética De La Investigación Con Medicamentos Del Principado De Asturias (Hospital Universitario De Asturias. Avd/ Roma S/n, Oviedo, 33011, Spain; +34 985107927; ceim.asturias@asturias.org), ref: 2023.244 2. Approved 27/12/2023, Komisija Za Deontološka in Etična Vprašanja - KDEV (Trubarjeva cesta 2, Ljubljana, 1000, Slovenia; +386 1 2441 400; info@nijz.si), ref: 631-21/2023-11 (013) 3. Approved 13/11/2023, Bioethics Committee at Medical University of Warsaw (Żwirki i Wigury 61, Warsaw, 02-091, Poland; +48 22 57 20 303; komisja.bioetyczna@wum.edu.pl), ref: KB/270/2023 4. Approved 24/10/2023, CEN (Comitato Etico Nazionale) (Viale Regina Elena 299, Rome, 00161, Italy; +39 06 49904022; segreteria.comitatoetico@iss.it), ref: 48519 5. Approved 21/09/2023, Ethics Comittee of General Alexandra Hospital (Vassilisis Sofias 80 , Athens, 11528 , Greece; +30 213 216 2653 ; grafeio.poiotitas@hosp-alexandra.gr), ref: 668/12-09-2023 6. Approved 17/02/2024, APDP local EC (Rua Rodrigo da Fonseca, 1, Lisbon, 1250-189, Portugal; +351 213816101; comissaoetica@apdp.pt), ref: 41/2024 7. Approved 06/02/2024, Gabinete de Projetos de Investigação Centro Académico Clínico ICBAS- CHUdS (Largo Prof. Abel Salazar, Porto, 4099- 001, Portugal; +351 222 077 500 | Ext: 1429; secretariado.etica@chporto.min-saude.pt), ref: 011-24 (010-DEFI/010-CE) 8. Approved 29/04/2024, Comissão de Ética para a Saúde da ARSLVT (Av. Estados Unidos da América, 75-77, Lisbon, 1749- 096, Portugal; +351 21 842 52 03; etica@arslvt.min-saude.pt), ref: 131/CES/INV/2023 9. Approved 16/01/2024, Comissão de Ética da ULS Baixo Alentejo (Rua Dr. António Fernando Covas Lima, Beja, 7801- 849, Portugal; +351 284 310 200; geral@ulsba.min-saude.pt), ref: EDOC/2023/5239 10. Approved 15/01/2024, Comissão de Ética da ARS Algarve (E.N.125 Sítio das Figuras, Lote 1, 2º andar, Faro, 8005- 145, Portugal; +351 284 310 200; ces@arsalgarve.min-saude.pt), ref: - 11. Approved 07/01/2025, Medical Research Council (Egészségügyi Tudományos Tanács) (Báthory u. 10, Budapest, 1054, Hungary; +36 1 795-5639; tukeb@bm.gov.hu), ref: - |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus (T2DM) |
| Intervention | In the project all the eligible participants will be provided with a lifestyle intervention based on the Reverse Diabetes2 Now (R2N BP.) There is a maximum of 20 participants per group. The total number of people involved in the intervention will be 860 across 12 countries. The intervention will be carried out in two rounds: First round (January-March 2024 to January-March 2025) with 340 participants and second round (October-December 2025 to October-December 2026) with 520 participants. All participants will receive the same intervention, in one of its modalities (face-to-face or virtual). Each country will establish its own modalities when it comes to the online community, such as developing an ad hoc platform, embedding it into existing digital platforms of the national/regional health systems, or using social media tools, etc. This digital environment will favour knowledge and experience sharing, facilitate exchanges, and increase motivation and commitment of the patients by learning from peers. Patients will be able to consult background information, recipes, and tips shared by the community. In CARE4DIABETES project, Reverse Diabetes2 Now is a 1-year lifestyle treatment and consists of two phases : a six-month intensive phase and an after-care phase of six-months. In order to start the program participants are referred to the program by their health professional. After a medical screening to determine if participants meet the inclusion and exclusion criteria participants can start the program. During the first six months of the program five group-based program days are organized. After 1, 3 and 6 months there are ‘return days’. Every program day participants receive presentations and workshops (e.g., cooking workshop, exercise workshop, coach sessions around the four pillars of the program: nutrition, exercise, relaxation and sleep). On the first return day participants are invited to bring a relative or friend to get acquainted with the program so they can support the participant at home. The intervention will be carried out by a multidisciplinary team that will take on different roles to meet the objectives of the intervention: nurse, nutritionist, coach and coordinator role. To maximise the results of the implementation, the consortium has decided to adopt the approach of the Deming / Plan-Do-Study-Act (PDSA) cycles to support the evidence-based adaptations of the primary pilot action plans and to monitor the pilot implementation in different stages and enable continuous improvement. Phase I and II pilot actions will be implemented on a total number of 860 type 2 diabetes patients. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Height is measured using a stadiometer at enrolment, 6 months, and 12 months 2. Weight is measured using a calibrated scale at enrolment, 6 months, and 12 months 3. BMI is calculated using height and weight measurements at enrolment, 6 months, and 12 months 4. Waist circumference is measured using a tape measure at enrolment, 6 months, and 12 months 5. Blood pressure is measured using a sphygmomanometer at enrolment, 6 months, and 12 months 6. Serum lipids (total cholesterol, HDL, LDL, triglycerides) are measured using a laboratory test at enrolment, 6 months, and 12 months 7. HbA1c is measured using a laboratory test at enrolment, 6 months, and 12 months 8. Medication for diabetes is recorded using medical records/interviews at enrolment, 6 months, and 12 months 9. Medication for blood pressure and lipids is self-reported using a questionnaire at enrolment, 6 months, and 12 months 10. Quality of life is measured using the EQ-5D-5L questionnaire at enrolment, 6 months, and 12 months 11. Perceived health is measured using a Likert scale question at enrolment, 6 months, and 12 months 12. Fatigue is measured using a Likert scale question at enrolment, 6 months, and 12 months 13. Sleep problems are measured using a Likert scale question at enrolment, 6 months, and 12 months 14. Physical activity (aerobic and muscle-strengthening) is measured using a self-report questionnaire at enrolment, 6 months, and 12 months 15. Diet is measured using a short food frequency questionnaire and Healthy Diet Index at enrolment, 6 months, and 12 months 16. Self-efficacy is measured using validated questions at enrolment, 6 months, and 12 months 17. Satisfaction in intervention is measured using NPS and additional questions at enrolment, 6 months, and 12 months |
| Secondary outcome measures | 1. Age is measured using a questionnaire at baseline 2. Sex is measured using a questionnaire at baseline 3. Diabetes duration is measured using a questionnaire at baseline 4. Immigrant background is measured using a questionnaire at baseline 5. Highest level of education is measured using a questionnaire at baseline 6. Income adequacy is measured using a Likert scale question at baseline 7. Family status is measured using a questionnaire at baseline 8. Employment status is measured using a questionnaire at baseline 9. Present smoking is measured using a questionnaire at baseline 10. Alcohol consumption is measured using a questionnaire at baseline 11. Special diet is measured using a questionnaire at baseline |
| Overall study start date | 01/02/2023 |
| Completion date | 31/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 860 |
| Total final enrolment | 860 |
| Key inclusion criteria | 1. Age 20-80 years 2. T2DM treated with medication (oral or injected medicines or insulin) 3. T2DM duration 1-10 years 4. BMI 25-40 kg/m² 5. No COPD or kidney or heart failure diagnosis 6. No bariatric surgery (self-reported/medical record) 7. No eating disorder (self-reported/medical record) 8. No pregnancy (self-reported/medical record) 9. Committed to make lifestyle changes to control T2DM 10. Ability to use necessary digital devices 11. Access to internet 12. Sufficient language skills to take part in the program 13. Possibility to take part in the program as provided (schedule, location) 14. Willingness to measure glucose at home |
| Key exclusion criteria | 1. Severe COPD 2. Bariatric surgery 3. Kidney failure 4. Heart failure 5. Pregnancy or planning to get pregnant during coming 12 months (self-report) 6. Eating disorder, with symptoms during the past 5 years (self-reported diagnosis) |
| Date of first enrolment | 17/02/2023 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- Belgium
- Bulgaria
- Finland
- Greece
- Hungary
- Italy
- Malta
- Poland
- Portugal
- Slovakia
- Slovenia
- Spain
Study participating centres
Mérida
06800
Spain
Warsaw
02-091
Poland
Warsaw
02-528
Poland
Rome
0161
Italy
Pisa Italy
56126
Italy
Rome
00159
Italy
Rome I
168
Italy
Athens
11528
Greece
Porto
4099-001
Portugal
Alenquer
2580-393
Portugal
Beja
7800-528
Portugal
Tavira
8800-534
Portugal
Budapest
1097
Hungary
Ixelles
1050
Belgium
Merche-en-Famenne
6900
Belgium
Ciney
5590
Belgium
Oviedo
33001
Spain
Oviedo
33011
Spain
Oviedo, Asturias
33005
Spain
Sponsor information
Government
Ciriaco Miguel Vigil, 9
Oviedo. Asturias
33006
Spain
| Phone | +34 696197060 |
|---|---|
| dgcuidados@asturias.org | |
| Website | http://www.asturias.es |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 01/02/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The Care4diabetes Joint action includes an strategy to widespread results among other EU population, medical professionals , and other relevant stakeholders. Planned publication in a peer-revieed journal too. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. All data shared during or after the project execution will be anonymized and agroupated. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 22/01/2025 | No | No | ||
| Protocol article | 19/03/2025 | 25/03/2025 | Yes | No |
Additional files
Editorial Notes
25/03/2025: Publication reference added.
03/03/2025: Internal review.
22/01/2025: Trial's existence confirmed by Comité De Ética De La Investigación Con Medicamentos Del Principado De Asturias.
