CARE4DIABETES - Reducing the burden of non-communicable diseases by providing a multi-disciplinary lifestyle treatment intervention for type 2 diabetes

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?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62063346

Enrollment

860

Registered

2025-02-25

Start date

2023-02-17

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus (T2DM) Nutritional, Metabolic, Endocrine

Interventions

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 numb

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Belgium, Bulgaria, Finland, Greece, Hungary, Italy, Malta, Poland, Portugal, Slovakia, Slovenia, Spain

Contacts

Public ContactMarta María Pisano González

martamaria.pisanogonzalez@asturias.org+34 696197060

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026