Actively Recruiting
Optimizing Sleep and Reducing Sedentary Behaviour in Adults with Type 2 Diabetes Mellitus: An Efficacy Study
Led by University of Leicester · Updated on 2025-03-27
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
U
University Hospitals, Leicester
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether it is possible to improve sleep quality and reduce sedentary behavior in adults living with Type 2 diabetes who have sleep problems. This clinical feasibility trial aims to find out if objectively measured sleep and sedentary habits can be improved and what effects these changes may have on physical and physiological health markers. The study will compare outcomes between participants who receive a special talking therapy and behavior change support and those who receive usual care. Participants in the intervention group will receive counseling on improving sleep and reducing sedentary time through Cognitive Behavioral Therapy for Insomnia (CBTi) and behavior change techniques over a 12-week period. They will keep sleep diaries and attend regular meetings with a qualified coach. The control group will receive a leaflet about good sleep hygiene and the benefits of less sedentary behavior. Both groups will complete tests and questionnaires at the start and end of the 12 weeks. During the study, researchers will collect data using devices like accelerometers to measure sleep efficiency and physical activity, along with questionnaires on sleep quality, fatigue, mood, and quality of life. They will also monitor blood pressure, blood glucose, body composition, and cognitive function before and after the intervention period. The total participation involves assessments at baseline and after 12 weeks, allowing researchers to compare changes across several health and lifestyle measures.
CONDITIONS
Brief Title
A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 2 diabetes for longer than 3 months
- Willing and able to give informed consent
- Sleep disorder symptom checklist score of 5 or higher on insomnia criteria
- Not at high risk of undiagnosed Obstructive Sleep Apnoea (score 5 or less on STOP BANG scale)
- Glycated haemoglobin (HbA1c) of 10% (86 mmol/mol) or less
- Male or female aged 18 to 75 years
- Able to walk without assistance or assistive device
- Not undertaking more than 75 minutes per week of strenuous exercise or sport
- Not taking opioids
- Treatment stable for at least 3 months
- Accelerometer-measured sleep efficiency of 85% or less
- Understand that CBTi may temporarily worsen sleep deprivation affecting daily life
You will not qualify if you...
- Diagnosed with narcolepsy or parasomnia
- Diagnosed with type 1 diabetes or gestational diabetes
- Recent cardiovascular event within the last 6 months
- Currently taking opioids
- Diagnosed with borderline personality disorder, psychosis, adult ADHD, or schizophrenia
- Living with epilepsy or seizures
- Shift workers
- Female planning pregnancy during the study period or currently pregnant
- Living with a terminal illness
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive a 12 week behavioral intervention to improve sleep and reduce sedentary behaviour using cognitive behavioral therapy for insomnia and behavior change techniques. Participants in the control group receive usual care with educational materials. Questionnaires and tests are completed at baseline and after the intervention for comparison.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Diabetes Research Centre University Hospitals Leicester
Leicester, Leicestershire, United Kingdom, LE5 4PW
Actively Recruiting
Research Team
A
Alix HA Covenant, MSc
J
Joe Henson, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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