The Step Up 2 Sleep Study
Research type
Research Study
Full title
An efficacy study exploring the optimisation of sleep and the reduction of sedentary behaviour in those living with type 2 diabetes mellitus
IRAS ID
334347
Contact name
Joe Henson
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
There are currently about 5 million people in the UK living with type 2 diabetes. This is worrying as these people are at a higher risk of other conditions including heart and kidney disease. They are also likely to be more sedentary.
Trouble sleeping is also more common in those living with type 2 diabetes. Reduced time or quality of sleep increases the risks for heart disease, stroke, and depression. One effective treatment for insomnia is called cognitive behavioural therapy insomnia (CBTi). Trials to reduce sedentary time have also been effective.
However, we don’t know if combining CBTi and help to be less sedentary will improve both sleep and decrease sedentary time. We also don’t know how this could help with physical function and wellbeing in those living with type 2 diabetes.
The main aims of the trial are to improve sleep and reduce sedentary time. Then we will see if this leads to improved blood sugar control, physical function and wellbeing, compared to standard care.
The assessments at the beginning and end of the trial will be at the Leicester Diabetes Centre. A total of 44 people (aged 40-75) will be randomly allocated to either standard care or a combination of CBTi and a programme aimed to reduce sedentary time.
Standard care – this group will receive their normal diabetes care, together with a leaflet outlining sleep education and good sleep hygiene and the benefits of being less sedentary. At the end of the trial, they will also be offered CBTi sessions.
The combined CBTi/sedentary reduction programme will start with 3 sessions of CBTi alone. Then add in the help to be less sedentary for a total of 12 weeks. We will then look at how sleep and sedentary time changes and how this affects blood sugar, physical function, and wellbeing.REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0252
Date of REC Opinion
30 Apr 2024
REC opinion
Further Information Favourable Opinion