Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

Not Applicable

Suspended

• Conditions: Insomnia; PreDiabetes; Sleep Deprivation
• Interventions: Behavioral: Intensive Lifestyle Intervention; Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention

• Registration Number: NCT04457440
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-30
• Study Start: 2020-07-01
• Study First Posted: 2020-07-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-17
• Last Update Posted: 2021-10-25
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Lifestyle Intervention (ILI)	Intensive Lifestyle Intervention	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.
ILI enhanced with cognitive behavioral sleep intervention	Intensive Lifestyle Intervention 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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Queen Mary Hpspital; 🇭🇰 Hong Kong, Hong Kong

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong