Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

NCT04457440 | Suspended DMC

• 2 other identifiers: EA1909037UW20-245
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

PreDiabetes; Insomnia; Sleep Deprivation

Keywords

Cognitive Behavioral Therapy; Lifestyle Intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• Changes in insomnia symptom severity

  12 weeks from baseline

• Changes in subjective sleep onset latency

  12 weeks from baseline

• Changes in subjective wake after sleep onset

  12 weeks from baseline

• Changes in subjective total sleep time

  12 weeks from baseline

• Changes in objective sleep onset latency

  12 weeks from baseline

Study Arms (2)

Intensive Lifestyle Intervention (ILI)

ACTIVE COMPARATOR

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

ILI enhanced with cognitive behavioral sleep intervention

EXPERIMENTAL

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

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

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 (ILI)

Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention BEHAVIORAL

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.

ILI enhanced with cognitive behavioral sleep intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hpspital

Hong Kong, Hong Kong

Location

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Prediabetic State; Sleep Initiation and Maintenance Disorders; Sleep Deprivation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wai Sze Chan, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

HK (2)