The goal of this clinical feasibility trial is to learn whether the investigators can improve sleep and reduce sedentary behaviour in people living with Type 2 diabetes mellitus with sleep problems. The main questions it aims to answer are: • question 1, can objectively measured sleep and sedentary behaviour be improved in the participants and • question 2, what effect will this have on a number of physical and physiological markers. Participants in the intervention group will be asked to keep sleep diaries and attend regular meetings with a qualified coach who will use a specific talking therapy to try to improve sleep and with use behaviour change techniques to help them be less sedentary. Researchers will compare the control group to the intervention group to see if effects differ between groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
A 12 week intervention using CBTi to improve sleep measured using objective and subjective measures. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.
Participants will be given a leaflet summarising good sleep practice and the advantages of reducing sedentary behaviour. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.
Participants will be encouraged to increase activity and thus reduce sedentary time. Investigators will use behaviour change techniques to aid in this goal. Participants will complete a number of questionnaires and tests at baseline and at completion to allow comparisons to be made.
Diabetes Research Centre University Hospitals Leicester
Leicester, Leicestershire, United Kingdom
RECRUITINGSleep Efficiency (SE) measured using accelerometer data.
The primary outcome measure is change in objectively measured SE in the intervention arm compared to the control group.
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - sleep onset latency
Accelerometer data will be used to measure sleep onset latency in minutes.
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - wake after sleep onset
Accelerometer data will be used to measure wake after sleep onset in minutes.
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - total sleep time
Accelerometer data will be used to measure total sleep time in minutes.
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - sleep duration variability
Accelerometer data will be used to measure sleep duration variability in minutes.
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sleep - sleep midpoint variability
Accelerometer data will be used to measure sleep midpoint variability in minutes.
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured sedentary behaviour
Accelerometer data will be used to measure total time spent in sedentary time in minutes.
Time frame: Before and after the 12 week intervention/intervention period
Objectively measured physical activity
Accelerometer data will be used to measure total time spent in physical activity in minutes.
Time frame: Before and after the 12 week intervention/intervention period
Subjectively measured sleep - insomnia
The Insomnia Severity index, will be used to measure the level of insomnia - it is a questionnaire and has a range of 0-28 with higher scores indicating more insomnia.
Time frame: Before and after the 12 week intervention/intervention period
Subjectively measured sleep quality -
The Pittsburgh Sleep Quality Index will be used to measure subjective sleep quality, this is a questionnaire and has a range of 0-21 with higher scores indicating worse sleep quality.
Time frame: Before and after the 12 week intervention/intervention period
Subjectively measured sleepiness
Epworth Sleepiness Scale is a questionnaire and has a range of 0-24 with higher scores indicating more sleepiness.
Time frame: Before and after the 12 week intervention/intervention period
Measurement of fatigue
The Functional assessment of chronic illness therapy (FACIT) scale will be used to subjectively measure fatigue, the range is 0-52 with higher scores indicating less fatigue.
Time frame: Before and after the 12 week intervention/intervention period
Blood pressure
Blood pressure (both diastolic and systolic) will be measured using an automatic electronic device and the units used will be millimetres of mercury.
Time frame: Before and after the 12 week intervention/intervention period
Fasting blood glucose
Fasting measured via a venous sample and in millimoles per litre (Mmol/L)
Time frame: Before and after the 12 week intervention/intervention period
Continuous blood glucose
Continuous blood glucose measured via a continuous glucose monitor and in Mmol/L (Mmol/L)
Time frame: Before and after the 12 week intervention/intervention period
Insulin
Insulin will be measured via a venous sample and in micro units per millilitre.
Time frame: Before and after the 12 week intervention/intervention period
Triglycerides
Triglycerides will be measured via a venous sample and in Mmol/L.
Time frame: Before and after the 12 week intervention/intervention period
Cholesterol
Cholesterol, including Low density lipoprotein and high density lipoprotein and total cholesterol, will be measured via a venous sample and in Mmol/L
Time frame: Before and after the 12 week intervention/intervention period
Physical function - the short physical performance battery
The short physical performance battery consists of 3 physical tests, with a total score range of 0-12 with higher scores indicating better physical function.
Time frame: Before and after the 12 week intervention/intervention period
Physical function - the sit to stand-60
The sit to stand-60 is the number of times the participant can rise from sit to stand in one minute using a designated chair with no arms and without the use of the participants arms, and is reported as a number.
Time frame: Before and after the 12 week intervention/intervention period
Physical and Cognitive function - The World Health Organisation Disability Assessment schedule (WHODAS)
WHODAS is a questionnaire used to assess both physical and cognitive function. Each question is scored 0-4, scores are then averaged for all the questions so the range is 0-4 and the higher the score the more difficulty the participant is experiencing in functioning.
Time frame: Before and after the 12 week intervention/intervention period
Cognitive function - verbal fluency test
Cognitive function will be measured using the verbal fluency test, which is conducted over two 60s periods and is scored by the number of correct answers.
Time frame: Before and after the 12 week intervention/intervention period
Quality of life- European Quality of Life 5 dimension (EQ-5D-5L)
EQ-5D-5L, the five questions are scored 1-5 and each represents a different aspect, it is presented as a five digit number representing each domain. The higher the numbers, the worse quality of life.
Time frame: Before and after the 12 week intervention/intervention period
Weight
Weight in kilograms will be measured.
Time frame: Before and after the 12 week intervention/intervention period
Height
Height in metres will be measured.
Time frame: Before and after the 12 week intervention/intervention period
Body mass index (BMI)
BMI will be calculated using weight and height to produce BMI in kg/m\^2
Time frame: Before and after the 12 week intervention/intervention period
Body composition - via bioimpedance
Bioimpedance scales will be used to measure body composition including percentage fat, muscle mass and water
Time frame: Before and after the 12 week intervention/intervention period
Depression - The Patient Health Questionnaire-9 (PHQ9)
PHQ9 will be used to measure depressive symptoms. The PHQ9 has a range of 0-27 with higher scores indicating more depressive symptoms/depression.
Time frame: Before and after the 12 week intervention/intervention period
Anxiety - The General Anxiety Disorder Assessment-7 (GAD7)
GAD7 will be used to measure anxiety symptoms. It has a range of 0-21, with higher scores indicating more anxiety.
Time frame: Before and after the 12 week intervention/intervention period
Food intake - food diaries
3 Day food diaries will be used to measure food intake.
Time frame: Before and after the 12 week intervention/intervention period
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