Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes
NCT ID: NCT04457440
Last Updated: 2021-10-25
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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SUSPENDED
NA
36 participants
INTERVENTIONAL
2020-07-01
2021-12-30
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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Intensive Lifestyle Intervention (ILI)
The ILI will consist of 8 group-based 90-min sessions focusing on modifying dietary and exercise habits with the goal of reducing 450kcal of daily calories and increasing physical activity to 150 minutes of exercise per week.
Intensive Lifestyle Intervention
This intervention is an abbreviated version of the Diabetes Prevention Program, which has been shown to be effective in reducing the risk of developing type 2 diabetes.
ILI enhanced with cognitive behavioral sleep intervention
The ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session.
Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention
This intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session. The additional sleep components will include (a) psychoeducation about the importance of sleep in weight control and glycemic control, (b) sleep hygiene, (c) stimulus control, (d) modifying maladaptive beliefs about sleep, (e) and, setting individualized sleep schedule and reviewing sleep schedule.
Interventions
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Intensive Lifestyle Intervention
This intervention is an abbreviated version of the Diabetes Prevention Program, which has been shown to be effective in reducing the risk of developing type 2 diabetes.
Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention
This intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session. The additional sleep components will include (a) psychoeducation about the importance of sleep in weight control and glycemic control, (b) sleep hygiene, (c) stimulus control, (d) modifying maladaptive beliefs about sleep, (e) and, setting individualized sleep schedule and reviewing sleep schedule.
Eligibility Criteria
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Inclusion Criteria
* (b) BMI \> 23kg/m2,
* (c) aged 18 to 65 year-old,
* (d) have prediabetes, defined by a plasma fasting glucose concentration of 5.6 to 6.9 mmol/L, impaired glucose tolerance (2hglucose 7.8-11.0 on OGTT), or HbA1c 5.7-6.4%,
* (e) have average habitual sleep duration \< 6.5 hours, confirmed by actigraphy measure of sleep for 2 weeks or have insomnia, confirmed in a clinical sleep interview and actigraph-measure of greater than 30 minutes of sleep onset latency or nighttime awakening for 3 nights or more per week
Exclusion Criteria
* (b) have any current severe mental illnesses,
* (c) have any medical conditions or medication use that could undermine the efficacy of the sleep intervention,
* (d) have shift work schedules,
* (e) have any environmental constraints on the feasibility of implementing a sleep schedule of at least 7.5 hours
18 Years
65 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Chan Wai Sze
Assistant Professor
Principal Investigators
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Wai Sze Chan, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Queen Mary Hpspital
Hong Kong, , Hong Kong
The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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UW20-245
Identifier Type: OTHER
Identifier Source: secondary_id
EA1909037
Identifier Type: -
Identifier Source: org_study_id