Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

The University of Hong Kong (HKU)

Status: Suspended

Conditions: Insomnia; Sleep Deprivation; PreDiabetes

Treatments: Behavioral: Intensive Lifestyle Intervention; Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04457440

EA1909037

UW20-245 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Intensive Lifestyle Intervention (ILI)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Intensive Lifestyle Intervention

ILI enhanced with cognitive behavioral sleep intervention

Experimental group

Description:

The ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session.

Treatment:

Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention