An interventional study of Culturally adapted Mediterranean diet and Supervised walking programme in Type 2 Diabetes, sponsored by University of Bologna. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Bologna · Not applicable, Interventional, and Treatment
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:
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:
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 101 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Behavioral: Culturally adapted Mediterranean diet · Behavioral: Supervised walking programme
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.
Behavioral: Standard dietary and behavioural counselling
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.
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.
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 3 months, 6 months, 12 months
Change in LDL cholesterol
Change from baseline in LDL cholesterol, expressed in mg/dL, measured on venous blood samples obtained as part of routine clinical care.
Time frame: Baseline, 3 months, 6 months, 12 months
Plan to share: No
Ran from Jun 2024 to primary completion in Jul 2026, 25 months.
Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 25 months is above that.
Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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