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Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

Primary Purpose

PreDiabetes, Insomnia, Sleep Deprivation

Status
Suspended
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Intensive Lifestyle Intervention
Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring Cognitive Behavioral Therapy, Lifestyle Intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen Mary Hpspital
  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intensive Lifestyle Intervention (ILI)

ILI enhanced with cognitive behavioral sleep intervention

Arm 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.

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

Outcomes

Primary Outcome Measures

Changes in HbA1C (%)
Changes in fasting glucose concentration (mg/dl)
Changes in 2-hr oral glucose tolerance (mg/dl)

Secondary Outcome Measures

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
Changes in subjective sleep onset latency
measured by daily sleep diary
Changes in subjective wake after sleep onset
measured by daily sleep diary
Changes in subjective total sleep time
measured by daily sleep diary
Changes in objective sleep onset latency
measured by actigraphy
Changes in objective wake after sleep onset
measured by actigraphy
Changes in objective total sleep time
measured by actigraphy
Changes in body weight (kg)
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
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
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
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.
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
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
Changes in dietary composition
Measured by the Chinese version of the 7-day Food Frequency Questionnaire

Full Information

First Posted
June 26, 2020
Last Updated
October 17, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04457440
Brief Title
Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes
Official Title
A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Suspended
Why Stopped
COVID pandemic affected recruitment.
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Insomnia, Sleep Deprivation
Keywords
Cognitive Behavioral Therapy, Lifestyle Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive Lifestyle Intervention (ILI)
Arm Type
Active Comparator
Arm 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.
Arm Title
ILI enhanced with cognitive behavioral sleep intervention
Arm Type
Experimental
Arm Description
The ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Lifestyle Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in HbA1C (%)
Time Frame
12 weeks from baseline
Title
Changes in fasting glucose concentration (mg/dl)
Time Frame
12 weeks from baseline
Title
Changes in 2-hr oral glucose tolerance (mg/dl)
Time Frame
12 weeks from baseline
Secondary Outcome Measure Information:
Title
Changes in insomnia symptom severity
Description
measured by the Insomnia Severity Index. The score ranges from 0 to 28. The higher the score, the greater the symptom severity
Time Frame
12 weeks from baseline
Title
Changes in subjective sleep onset latency
Description
measured by daily sleep diary
Time Frame
12 weeks from baseline
Title
Changes in subjective wake after sleep onset
Description
measured by daily sleep diary
Time Frame
12 weeks from baseline
Title
Changes in subjective total sleep time
Description
measured by daily sleep diary
Time Frame
12 weeks from baseline
Title
Changes in objective sleep onset latency
Description
measured by actigraphy
Time Frame
12 weeks from baseline
Title
Changes in objective wake after sleep onset
Description
measured by actigraphy
Time Frame
12 weeks from baseline
Title
Changes in objective total sleep time
Description
measured by actigraphy
Time Frame
12 weeks from baseline
Title
Changes in body weight (kg)
Time Frame
12 weeks from baseline
Title
Changes in psychological distress
Description
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
Time Frame
12 weeks from baseline
Title
Changes in quality of life
Description
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
Time Frame
12 weeks from baseline
Title
Changes in food craving
Description
Measured by the Food Craving Questionnaire. The score ranges from 10 to 70. The higher the score, the greater the food craving
Time Frame
12 weeks from baseline
Title
Changes in acceptance of physical activity
Description
Measured by the Physical Activity Acceptance and Action Questionnaire. The score ranges from 10 to 70. The higher the score, the greater acceptance.
Time Frame
12 weeks from baseline
Title
Changes in weight loss self efficacy
Description
Measured by the Weight Loss Self Efficacy Scale. The score ranges from 0 to 100%. The higher the percentage, the greater the self-efficacy
Time Frame
12 weeks from baseline
Title
Changes in weight control strategies
Description
Measured by the Weight Control Strategy Scale. The score ranges from 0 to 120. The higher the percentage, the more effective strategies are used
Time Frame
12 weeks from baseline
Title
Changes in dietary composition
Description
Measured by the Chinese version of the 7-day Food Frequency Questionnaire
Time Frame
12 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Sze Chan, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hpspital
City
Hong Kong
Country
Hong Kong
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be shared with other researchers for review purposes.

Learn more about this trial

Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

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