NCT06471634

A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus

An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Insomnia
• Sedentary Behavior

Interventions

Type	Name	Description
BEHAVIORAL	CBTi	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.
OTHER	Control - usual care	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.
BEHAVIORAL	Sedentary behaviour reduction	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.

Timeline

• Start date: 2024-09-02
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-06-24
• Last updated: 2025-03-27

Locations

1 site across 1 country: United Kingdom