The healthy eating & active lifestyles for diabetes trial

Not Applicable

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN14344948
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-24
• Last Update Posted: 29 July 2024
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Adult =18 years of age
2. People of Black African, Black Caribbean, Black British, Black other, and Mixed race with either African or Caribbean ancestry
3. Type 2 diabetes
4. HbA1c =100 mmol/mol (or fructosamine <450 µmol for individuals with sickle cell trait/disease)
5. Suitable for group-based training
6. Suitable for participation in physical activity
7. Willing to undergo randomisation
8. Able to provide informed consent

Exclusion Criteria

1. Current pregnancy
2. Complex medical or lifestyle needs that require personalised advice or for which group-based training is unsuitable e.g. advanced chronic kidney disease
3. Complex learning needs that require personalised advice or for which group-based training is unsuitable e.g. people with learning disabilities
4. Need for language translation services (spoken or written)
5. Unable or unwilling to provide informed consent
6. Current participation in a competing clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control measured as HbA1c (mmol/mol) at 12 months