Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

Study Overview
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Brief Summary
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The proposed study aims to evaluate if improving sleep could enhance the intensive lifestyle intervention for improving weight loss and glycemic control in prediabetic individuals who have insomnia with short sleep duration. A cognitive behavioral intervention for insomnia with adjustments aimed at increasing sleep duration (CBT-Sleep) will be used for this study.

Official Title
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A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes

Conditions
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PreDiabetes, Insomnia, Sleep Deprivation

Intervention / Treatment
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* Behavioral: Intensive Lifestyle Intervention
* Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (a) Hong Kong residents, (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: (a) have unmanaged sleep apnea or other sleep disorders, (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive Lifestyle Intervention (ILI)<br>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. | Behavioral: Intensive Lifestyle Intervention<br>* 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.<br>|
| Experimental: ILI enhanced with cognitive behavioral sleep intervention<br>The ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session. | Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1C (%) |  | 12 weeks from baseline | 
| Changes in fasting glucose concentration (mg/dl) |  | 12 weeks from baseline | 
| Changes in 2-hr oral glucose tolerance (mg/dl) |  | 12 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in insomnia symptom severity | measured by the Insomnia Severity Index. The score ranges from 0 to 28. The higher the score, the greater the symptom severity | 12 weeks from baseline | 
| Changes in subjective sleep onset latency | measured by daily sleep diary | 12 weeks from baseline | 
| Changes in subjective wake after sleep onset | measured by daily sleep diary | 12 weeks from baseline | 
| Changes in subjective total sleep time | measured by daily sleep diary | 12 weeks from baseline | 
| Changes in objective sleep onset latency | measured by actigraphy | 12 weeks from baseline | 
| Changes in objective wake after sleep onset | measured by actigraphy | 12 weeks from baseline | 
| Changes in objective total sleep time | measured by actigraphy | 12 weeks from baseline | 
| Changes in body weight (kg) |  | 12 weeks from baseline | 
| Changes in psychological distress | the validated Chinese version of the Depression Anxiety Stress Scales (DASS-21)will be used. The score ranges from 0 to 63. The higher the score, the greater the distress | 12 weeks from baseline | 
| Changes in quality of life | the validated Chinese version of the Satisfaction with Life Scale will be used to measure quality of life. The score ranges from 5 to 35. The higher the score, the greater the quality of life | 12 weeks from baseline | 
| Changes in food craving | Measured by the Food Craving Questionnaire. The score ranges from 10 to 70. The higher the score, the greater the food craving | 12 weeks from baseline | 
| Changes in acceptance of physical activity | Measured by the Physical Activity Acceptance and Action Questionnaire. The score ranges from 10 to 70. The higher the score, the greater acceptance. | 12 weeks from baseline | 
| Changes in weight loss self efficacy | Measured by the Weight Loss Self Efficacy Scale. The score ranges from 0 to 100%. The higher the percentage, the greater the self-efficacy | 12 weeks from baseline | 
| Changes in weight control strategies | Measured by the Weight Control Strategy Scale. The score ranges from 0 to 120. The higher the percentage, the more effective strategies are used | 12 weeks from baseline | 
| Changes in dietary composition | Measured by the Chinese version of the 7-day Food Frequency Questionnaire | 12 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, Lifestyle Intervention