A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus
NCT ID: NCT06471634
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
44 participants
INTERVENTIONAL
2024-09-02
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CBTi and Sedentary Behaviour support
Participants will be counselled in how to improve their sleep and decrease sedentary behaviour using CBTi and behaviour change techniques.
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.
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.
Control - usual care
Participants will be given a leaflet containing brief information on good sleep hygiene practice and the benefits of decreasing sedentary behaviour.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Participant is willing and able to give informed consent to take part in the study.
* Sleep disorder symptom checklist 25 (SDS-CL-25) of ≥5 on insomnia criteria.
* Not at high risk of undiagnosed Obstructive Sleep Apnoea (OSA), scoring ≥5 on STOP BANG scale (snoring, tired, observed, pressure, body mass index, age, neck size, gender) diagnosed treated OSA is acceptable.
* Glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol) or less
* Male or Females.
* ≥ 18 ≤ 75 years of age.
* Able to walk without the use of an assistive device or requiring assistance from another person.
* Not undertaking more than 75 minutes a week of strenuous exercise or sport.
* Not taking opioids
* Be treatment stable for at least 3 months
* Accelerometer measurement of SE ≤ 85%
* An understanding that CBTi may exacerbate sleep deprivation in the short term which may impact on certain aspects of daily life.
Exclusion Criteria
* Individuals with type 1 diabetes or gestational diabetes
* Recent cardiovascular event (within the last 6 months).
* Currently on opioids
* Diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (ADHD) or schizophrenia (self-reported).
* Individuals living with epilepsy or seizures.
* Shift workers
* Female participant planning to become pregnant with the timeframe of the study or is currently pregnant.
* Terminal illness.
18 Years
75 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
University of Leicester
OTHER
Responsible Party
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Principal Investigators
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Melanie Davies, PhD
Role: PRINCIPAL_INVESTIGATOR
Leicester Diabetes Centre
Locations
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Diabetes Research Centre University Hospitals Leicester
Leicester, Leicestershire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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334347
Identifier Type: OTHER
Identifier Source: secondary_id
0955
Identifier Type: -
Identifier Source: org_study_id
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