Type 2 Diabetes4DI PLAN'EATNCT07887477
Different Diets in Different Diabetes - 4DI PLAN'EAT Pilot Study
A study testing Culturally adapted Mediterranean diet, Supervised walking programme and Standard dietary and behavioural counselling in people with Type 2 Diabetes, run by University of Bologna at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn whether a diet adapted to a person's cultural background, combined with a supervised physical activity programme, improves blood sugar control better than standard dietary advice in adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Culturally adapted Mediterranean diet, Supervised walking programme and Standard dietary and behavioural counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years at the time of signing the informed consent
- Belonging to one of the following ethnic groups: Italian, Eastern European, North African, or from the Indian subcontinent (India, Pakistan, Bangladesh, Sri Lanka)
- Diagnosis of type 2 diabetes mellitus
- Understanding of the Italian or English language
Who cannot join
- Type 1 diabetes mellitus
- Inability or unwillingness to participate in a structured physical activity program
- Active malignancy
- Chronic kidney disease (GFR < 30 ml/min), heart failure (NYHA class 3 or 4), or hepatic failure
- Previous bariatric surgery
- Adherence to a weight-loss diet in the 3 months preceding the study
- Use of illicit or abused substances in the 3 months preceding the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O.C. Endocrinologia e Prevenzione e Cura del Diabete, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, 40138
About this study
Official title: "Different Diets in Different Diabetes" - Diete Diverse Per Diversi Diabetici
The goal of this clinical trial is to learn whether a diet adapted to a person's cultural background, combined with a supervised physical activity programme, improves blood sugar control better than standard dietary advice in adults with type 2 diabetes. Participants come from four cultural backgrounds (Italian, Eastern European, North African, and South Asian) and live in Italy.
The main questions it aims to answer are:
Read more
- Does a culturally adapted Mediterranean diet combined with structured physical activity lower glycated haemoglobin (HbA1c) more than standard dietary advice?
- Does it reduce body weight, body mass index and waist circumference more than standard dietary advice?
Researchers will compare participants who receive the culturally adapted diet and the supervised walking programme with participants who receive standard dietary and behavioural advice, to see whether the adapted approach improves blood sugar control and body measurements more. Participants in both groups continue to receive their diabetes medication, adjusted as needed according to clinical guidelines.
Participants will:
- Attend medical visits at the start of the study and after 3, 6 and 12 months, where body weight, waist circumference, blood pressure and heart rate are measured and blood test results are reviewed;
- Meet a dietitian at the start of the study and after 3, 6 and 12 months;
- Complete questionnaires on perceived stress, sleep quality, mood and general health at each medical visit;
- Provide a finger-prick dried blood spot sample and a saliva sample at the beginning and end of each medical visit;
- If they choose to be assigned to the culturally adapted group, follow a personalised diet built around traditional dishes from their country of origin and take part in supervised group walks at least once a week for 12 months.
- Conditions
- Type 2 Diabetes
- Being tested
- Culturally adapted Mediterranean diet, Supervised walking programme, Standard dietary and behavioural counselling
- Keywords
- Plan'Eat, PLANEAT, Type 2 Diabetes, Migrant, Diet, Cultural, Low SES
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted Mediterranean dietBehavioural
Individualised dietary plan designed by a registered dietitian starting from the participant's habitual food intake, in collaboration with professional cooks. The plan retains the macronutrient composition of a Mediterranean-style prescription but delivers it through traditional dishes and ingredients of the participant's country of origin (Italy, Eastern Europe, North Africa, or the Indian subcontinent), and accommodates religious dietary restrictions. Delivery is supported by short recipe videos, co-developed with a local hospitality school, demonstrating healthy preparation of traditional dishes. Adherence is reviewed by the dietitian at baseline, 3, 6 and 12 months.
Supervised walking programmeBehavioural
Structured group walking programme delivered by trained staff over 12 months, with sessions offered on a regular weekly basis. Exercise intensity is prescribed using heart rate reserve calculated with the Karvonen equation, beginning at a low intensity appropriate for untrained individuals and increasing progressively over the course of the programme, with session duration also increasing progressively. Sessions are conducted in groups within the participant's local neighbourhood. The programme is offered free of charge and is additional to the general physical activity advice given to all participants.
Standard dietary and behavioural counsellingBehavioural
Dietary and behavioural recommendations for type 2 diabetes delivered according to Italian national guidelines (SID-AMD) and international standards, without adaptation to the participant's cultural food practices. Advice to increase physical activity is provided, without supervision or attendance monitoring. Counselling is delivered by the same dietetic team and reviewed at the same intervals as the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Culturally adapted diet plus supervised physical activity | Experimental | Participants receive a personalised dietary plan developed by a registered dietitian in collaboration with professional cooks. The plan follows Mediterranean diet principles while being built around traditional dishes and ingredients from the participant's country of origin, respecting religious dietary requirements. Participants also take part in a supervised walking programme with a flexible schedule, with heart rate monitored at each session. Glucose-lowering therapy is adjusted as needed according to clinical guidelines. Receives: Behavioral: Culturally adapted Mediterranean diet; Behavioral: Supervised walking programme |
| Standard dietary and behavioural advice | Active comparator | Participants receive standard dietary and behavioural recommendations in accordance with national and international guidelines, together with general advice to increase physical activity. They do not receive the culturally adapted dietary plan or the supervised walking programme. Glucose-lowering therapy is adjusted as needed according to clinical guidelines. Receives: Behavioral: Standard dietary and behavioural counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c)
Change from baseline in HbA1c, expressed in mmol/mol, measured on venous blood samples obtained as part of routine clinical care. A reduction indicates improved glycaemic control.
Measured: Baseline, 3 months, 6 months, 12 months
Change in body weight
Change from baseline in body weight, measured in kilograms by trained staff using a calibrated clinical scale with the participant wearing light clothing and no shoes.
Measured: Baseline, 3 months, 6 months, 12 months
Change in body mass index (BMI)
Change from baseline in body mass index, calculated as body weight in kilograms divided by the square of height in metres (kg/m^2).
Measured: Baseline, 3 months, 6 months, 12 months
Change in waist circumference
Change from baseline in waist circumference, measured in centimetres by trained staff using a standardised procedure. A reduction indicates a decrease in central adiposity, a marker of cardiovascular risk.
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start3 Jun 2024
- Primary completion31 Jul 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Responsible party
- Principal investigator, Uberto Pagotto, University of Bologna
- Investigators
- Uberto Pagotto, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887477
- Sponsor's protocol ID
- 248/2023/Sper/AOUBo
- Other IDs
- 101061023
- Acronym
- 4DI PLAN'EAT
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marchesini G, Bernardi D, Miccoli R, Rossi E, Vaccaro O, De Rosa M, Bonora E, Bruno G. Under-treatment of migrants with diabetes in a universalistic health care system: the ARNO Observatory. Nutr Metab Cardiovasc Dis. 2014 Apr;24(4):393-9. doi: 10.1016/j.numecd.2013.09.012. Epub 2013 Nov 1.
PubMed 24462046
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Different Diets in Different Diabetes" - Diete Diverse Per Diversi Diabetici
- ClinicalTrials.gov ID
- NCT07887477
- Acronym / sponsor ID
- 4DI PLAN'EAT / 248/2023/Sper/AOUBo
- Conditions
- Type 2 Diabetes
- Keywords
- Plan'Eat, PLANEAT, Type 2 Diabetes, Migrant, Diet, Cultural, Low SES
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a diet adapted to a person's cultural background, combined with a supervised physical activity programme, improves blood sugar control better than standard dietary advice in adults with type 2 diabetes. Participants come from four cultural backgrounds (Italian, Eastern European, North African, and South Asian) and live in Italy.
The main questions it aims to answer are:
- Does a culturally adapted Mediterranean diet combined with structured physical activity lower glycated haemoglobin (HbA1c) more than standard dietary advice?
- Does it reduce body weight, body mass index and waist circumference more than standard dietary advice?
Researchers will compare participants who receive the culturally adapted diet and the supervised walking programme with participants who receive standard dietary and behavioural advice, to see whether the adapted approach improves blood sugar control and body measurements more. Participants in both groups continue to receive their diabetes medication, adjusted as needed according to clinical guidelines.
Participants will:
- Attend medical visits at the start of the study and after 3, 6 and 12 months, where body weight, waist circumference, blood pressure and heart rate are measured and blood test results are reviewed;
- Meet a dietitian at the start of the study and after 3, 6 and 12 months;
- Complete questionnaires on perceived stress, sleep quality, mood and general health at each medical visit;
- Provide a finger-prick dried blood spot sample and a saliva sample at the beginning and end of each medical visit;
- If they choose to be assigned to the culturally adapted group, follow a personalised diet built around traditional dishes from their country of origin and take part in supervised group walks at least once a week for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted diet plus supervised physical activity | Experimental | Behavioral: Culturally adapted Mediterranean diet, Behavioral: Supervised walking programmeParticipants receive a personalised dietary plan developed by a registered dietitian in collaboration with professional cooks. The plan follows Mediterranean diet principles while being built around traditional dishes and ingredients from the participant's country of origin, respecting religious dietary requirements. Participants also take part in a supervised walking programme with a flexible schedule, with heart rate monitored at each session. Glucose-lowering therapy is adjusted as needed according to clinical guidelines. |
| Standard dietary and behavioural advice | Active comparator | Behavioral: Standard dietary and behavioural counsellingParticipants receive standard dietary and behavioural recommendations in accordance with national and international guidelines, together with general advice to increase physical activity. They do not receive the culturally adapted dietary plan or the supervised walking programme. Glucose-lowering therapy is adjusted as needed according to clinical guidelines. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 70 years at the time of signing the informed consent
- Belonging to one of the following ethnic groups: Italian, Eastern European, North African, or from the Indian subcontinent (India, Pakistan, Bangladesh, Sri Lanka)
- Diagnosis of type 2 diabetes mellitus
- Understanding of the Italian or English language
Key exclusion criteria (7 listed)
- Type 1 diabetes mellitus
- Inability or unwillingness to participate in a structured physical activity program
- Active malignancy
- Chronic kidney disease (GFR < 30 ml/min), heart failure (NYHA class 3 or 4), or hepatic failure
- Previous bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally adapted Mediterranean dietIndividualised dietary plan designed by a registered dietitian starting from the participant's habitual food intake, in collaboration with professional cooks. The plan retains the macronutrient composition of a Mediterranean-style prescription but delivers it through traditional dishes and ingredients of the participant's country of origin (Italy, Eastern Europe, North Africa, or the Indian subcontinent), and accommodates religious dietary restrictions. Delivery is supported by short recipe videos, co-developed with a local hospitality school, demonstrating healthy preparation of traditional dishes. Adherence is reviewed by the dietitian at baseline, 3, 6 and 12 months. | Behavioural | Culturally adapted diet plus supervised physical activity |
| Supervised walking programmeStructured group walking programme delivered by trained staff over 12 months, with sessions offered on a regular weekly basis. Exercise intensity is prescribed using heart rate reserve calculated with the Karvonen equation, beginning at a low intensity appropriate for untrained individuals and increasing progressively over the course of the programme, with session duration also increasing progressively. Sessions are conducted in groups within the participant's local neighbourhood. The programme is offered free of charge and is additional to the general physical activity advice given to all participants. | Behavioural | Culturally adapted diet plus supervised physical activity |
| Standard dietary and behavioural counsellingDietary and behavioural recommendations for type 2 diabetes delivered according to Italian national guidelines (SID-AMD) and international standards, without adaptation to the participant's cultural food practices. Advice to increase physical activity is provided, without supervision or attendance monitoring. Counselling is delivered by the same dietetic team and reviewed at the same intervals as the experimental arm. | Behavioural | Standard dietary and behavioural advice |
Primary outcome
Change in glycated haemoglobin (HbA1c)
Time frame: Baseline, 3 months, 6 months, 12 months
Change from baseline in HbA1c, expressed in mmol/mol, measured on venous blood samples obtained as part of routine clinical care. A reduction indicates improved glycaemic control.
Change in body weight
Time frame: Baseline, 3 months, 6 months, 12 months
Change from baseline in body weight, measured in kilograms by trained staff using a calibrated clinical scale with the participant wearing light clothing and no shoes.
Change in body mass index (BMI)
Time frame: Baseline, 3 months, 6 months, 12 months
Change from baseline in body mass index, calculated as body weight in kilograms divided by the square of height in metres (kg/m^2).
Change in waist circumference
Time frame: Baseline, 3 months, 6 months, 12 months
Change from baseline in waist circumference, measured in centimetres by trained staff using a standardised procedure. A reduction indicates a decrease in central adiposity, a marker of cardiovascular risk.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 24462046Marchesini G, Bernardi D, Miccoli R, Rossi E, Vaccaro O, De Rosa M, Bonora E, Bruno G. Under-treatment of migrants with diabetes in a universalistic health care system: the ARNO Observatory. Nutr Metab Cardiovasc Dis. 2014 Apr;24(4):393-9. doi: 10.1016/j.numecd.2013.09.012. Epub 2013 Nov 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uberto Pagotto principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted Mediterranean diet, Supervised walking programme and Standard dietary and behavioural counselling in people with Type 2 Diabetes, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) (time frame: Baseline, 3 months, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07887477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.