Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Intervention group: The HEAL-D programme consists of 16 hours of group-based education and support (eight 2-hr sessions) delivered using face-to-face or online delivery modes. Sessions 1-7 are deliver
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic control measured as HbA1c (mmol/mol) at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Glycaemic control measured as HbA1c (mmol/mol) at 6 and 24 months. 2. Blood lipids measured as total cholesterol and HDL-cholesterol (mmol/L) at 6, 12 and 24 months 3. Blood pressure measured as systolic and diastolic blood pressure (mmHg) at 6, 12 and 24 months 4. Body weight (kg) measured using scales at 6, 12 and 24 months 5. Body mass index (kg/m2) calculated from height and weight measurements at 6, 12 and 24 months 6. Waist circumference (cm) measured using a tape measure at 6, 12 and 24 months 7. Body composition measured as fat mass and lean mass (kg) using bioelectrical impedance analysis at 6, 12 and 24 months 8. Quality of life measured using the EQ5D-5L at 6, 12 and 24 months 9. Diabetes-related distress measured using the Problem Areas In Diabetes-5 questionnaire at 6, 12 and 24 months 10. Depressive symptoms measured using the Patient Health Questionnaire at 6, 12 and 24 months 11. Diabetes knowledge measured using the Short Diabetes Knowledge Instrument at 6, 12 and 24 months 12. Diabetes self-efficacy measured using the Diabetes Management Self-Efficacy Scale questionnaire at 6, 12 and 24 months 13. Diabetes dietary competence measured using the Perceived Diabetes & Dietary Competence questionnaire at 6, 12 and 24 months 14. Multimorbidity treatment burden measured using the Multimorbidity Treatment Burden Questionnaire at 6, 12 and 24 months 15. Physical activity measured using the short International Physical Activity Questionnaire at 6, 12 and 24 months 16. Physical activity measured using accelerometery at 12 months 17. Diet quality measured using the Diet Quality Questionnaire at 6, 12 and 24 months 18. Health service resource utilisation measured using the adapted Adult Service Use Schedule at 6, 12 and 24 months | — |
Countries
England, United Kingdom
Contacts
Public ContactLouise Goff
Outcome results
None listed