A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
NCT Number: NCT06471634
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2|Insomnia|Sedentary Behavior
Interventions: BEHAVIORAL: CBTi|OTHER: Control - usual care|BEHAVIORAL: Sedentary behaviour reduction
Sponsor: University of Leicester
Collaborators: University Hospitals, Leicester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-07
Locations: Diabetes Research Centre University Hospitals Leicester, Leicester, Leicestershire, LE5 4PW, United Kingdom

Summary:
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.

Primary Outcome Measures: Sleep 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., Before and after the 12 week intervention/intervention period
Secondary Outcome Measures: Objectively measured sleep - sleep onset latency, Accelerometer data will be used to measure sleep onset latency in minutes., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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), 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), Before and after the 12 week intervention/intervention period|Insulin, Insulin will be measured via a venous sample and in micro units per millilitre., Before and after the 12 week intervention/intervention period|Triglycerides, Triglycerides will be measured via a venous sample and in Mmol/L., 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, 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., 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., 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., 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., 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., Before and after the 12 week intervention/intervention period|Weight, Weight in kilograms will be measured., Before and after the 12 week intervention/intervention period|Height, Height in metres will be measured., 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, 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, 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., 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., Before and after the 12 week intervention/intervention period|Food intake - food diaries, 3 Day food diaries will be used to measure food intake., Before and after the 12 week intervention/intervention period