Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

October 17, 2021 updated by: Dr. Chan Wai Sze, The University of Hong Kong

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hpspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 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.
Behavioral: 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.
EXPERIMENTAL: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in HbA1C (%)
Time Frame: 12 weeks from baseline
12 weeks from baseline
Changes in fasting glucose concentration (mg/dl)
Time Frame: 12 weeks from baseline
12 weeks from baseline
Changes in 2-hr oral glucose tolerance (mg/dl)
Time Frame: 12 weeks from baseline
12 weeks from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in insomnia symptom severity
Time Frame: 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
12 weeks from baseline
Changes in subjective sleep onset latency
Time Frame: 12 weeks from baseline
measured by daily sleep diary
12 weeks from baseline
Changes in subjective wake after sleep onset
Time Frame: 12 weeks from baseline
measured by daily sleep diary
12 weeks from baseline
Changes in subjective total sleep time
Time Frame: 12 weeks from baseline
measured by daily sleep diary
12 weeks from baseline
Changes in objective sleep onset latency
Time Frame: 12 weeks from baseline
measured by actigraphy
12 weeks from baseline
Changes in objective wake after sleep onset
Time Frame: 12 weeks from baseline
measured by actigraphy
12 weeks from baseline
Changes in objective total sleep time
Time Frame: 12 weeks from baseline
measured by actigraphy
12 weeks from baseline
Changes in body weight (kg)
Time Frame: 12 weeks from baseline
12 weeks from baseline
Changes in psychological distress
Time Frame: 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
12 weeks from baseline
Changes in quality of life
Time Frame: 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
12 weeks from baseline
Changes in food craving
Time Frame: 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
12 weeks from baseline
Changes in acceptance of physical activity
Time Frame: 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.
12 weeks from baseline
Changes in weight loss self efficacy
Time Frame: 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
12 weeks from baseline
Changes in weight control strategies
Time Frame: 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
12 weeks from baseline
Changes in dietary composition
Time Frame: 12 weeks from baseline
Measured by the Chinese version of the 7-day Food Frequency Questionnaire
12 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA1909037
  • UW20-245 (OTHER: HKU/HA HKW IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared with other researchers for review purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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