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Different Diets in Different Diabetes - 4DI PLAN'EAT Pilot Study
Sponsor: University of Bologna
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. 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.
Official title: "Different Diets in Different Diabetes" - Diete Diverse Per Diversi Diabetici
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2024-06-03
Completion Date
2026-11-30
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Culturally adapted Mediterranean diet
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 programme
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 counselling
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.
Locations (1)
U.O.C. Endocrinologia e Prevenzione e Cura del Diabete, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, Italy