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

NCT07887477 | Active Not Recruiting

• 2 other identifiers: 248/2023/Sper/AOUBo101061023
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Plan'Eat; PLANEAT; Type 2 Diabetes; Migrant; Diet; Cultural; Low SES

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  Baseline, 3 months, 6 months, 12 months

Other Outcomes (1)

• Change in LDL cholesterol

  Baseline, 3 months, 6 months, 12 months

Study Arms (2)

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.

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.

Behavioral: Standard dietary and behavioural counselling

Interventions

Culturally adapted Mediterranean diet BEHAVIORAL

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.

Culturally adapted diet plus supervised physical activity

Supervised walking programme BEHAVIORAL

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.

Culturally adapted diet plus supervised physical activity

Standard dietary and behavioural counselling BEHAVIORAL

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.

Standard dietary and behavioural advice

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator

Study Sites (1)

U.O.C. Endocrinologia e Prevenzione e Cura del Diabete, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, BO, 40138, Italy

Location

Related Publications (1)

• 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.

  PMID: 24462046 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Uberto Pagotto

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 21, 2026
• Study Start: June 3, 2024
• Primary Completion: July 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)