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

NCT06471634 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-03-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospitals, Leicester

    collaborator OTHER

  • University of Leicester

    lead OTHER

Principal Investigators

  • Melanie Davies, PhD · Leicester Diabetes Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06471634 on ClinicalTrials.gov