Different Diets in Different Diabetes - 4DI PLAN'EAT Pilot Study

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 101
• From 3 Jun 2024 to the primary completion date, 31 Jul 2026
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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