The Healthy Eating & Active Lifestyles for Diabetes ('HEAL-D') Trial.

• Research type

  Research Study

• Full title

  HEAL-D (Healthy Eating & Active Lifestyles for Diabetes): a multicentre, pragmatic randomised controlled trial comparing effectiveness and cost-effectiveness of culturally tailored versus standard diabetes self-management programmes in Black-African and Black-Caribbean adults with type 2 diabetes

• IRAS ID

  326064

• Contact name

  Louise Goff

• Contact email

  louise.goff@leicester.ac.uk

• Sponsor organisation

  University of Leicester

• ISRCTN Number

  ISRCTN14344948

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  BACKGROUND.
  Type 2 diabetes (T2D) disproportionately affects people of Black-African and Black-Caribbean heritage in the UK and can have serious health consequences e.g. blindness and kidney failure, which affect people’s quality of life and costs the NHS a lot of money. One of the most important ways to avoid T2D complications is to follow a healthy diet and increase physical activity.

  AIM.
  Healthy Eating and Active Lifestyles for Diabetes ('HEAL-D’) is a culturally tailored diet and physical activity education and support programme for adults of African and Caribbean heritage who have T2D. The aim of this study is to assess the benefits of HEAL-D compared to standard T2D education courses and to determine if HEAL-D is cost effective.

  RESEARCH PROPOSAL.
  We will run the study in London, West Midlands and Greater Manchester. Adults of African and Caribbean heritage with T2D will be identified through their GP or through referral to existing T2D education courses. People who are eligible and want to take part will be contacted by the study team, using a short video to explain the study. Those who want to take part will be randomly allocated by a computer into one of two groups:
  •HEAL-D
  •Standard diabetes education course
  Participants will decide if they want to attend their education course face-to-face or using online video calling facilities. We will recruit 300 people over 11 months and collect data from participants for 2 years to measure their diabetes control and other measures such as blood pressure and quality of life. We will assess the value for money of the HEAL-D programme. We will investigate which parts of HEAL-D are helpful by interviewing a group of participants as well as the people who delivered it.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  24/EM/0079

• Date of REC Opinion

  22 Apr 2024

• REC opinion

  Further Information Favourable Opinion