Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

Sponsor
The University of Hong Kong (Other)
Overall Status
Suspended
CT.gov ID
NCT04457440
Collaborator
(none)
36
2
2
18
18
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intensive Lifestyle Intervention
  • Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in HbA1C (%) [12 weeks from baseline]

  2. Changes in fasting glucose concentration (mg/dl) [12 weeks from baseline]

  3. Changes in 2-hr oral glucose tolerance (mg/dl) [12 weeks from baseline]

Secondary Outcome Measures

  1. 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

  2. Changes in subjective sleep onset latency [12 weeks from baseline]

    measured by daily sleep diary

  3. Changes in subjective wake after sleep onset [12 weeks from baseline]

    measured by daily sleep diary

  4. Changes in subjective total sleep time [12 weeks from baseline]

    measured by daily sleep diary

  5. Changes in objective sleep onset latency [12 weeks from baseline]

    measured by actigraphy

  6. Changes in objective wake after sleep onset [12 weeks from baseline]

    measured by actigraphy

  7. Changes in objective total sleep time [12 weeks from baseline]

    measured by actigraphy

  8. Changes in body weight (kg) [12 weeks from baseline]

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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

  15. Changes in dietary composition [12 weeks from baseline]

    Measured by the Chinese version of the 7-day Food Frequency Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Mary Hpspital Hong Kong Hong Kong
2 The University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Wai Sze Chan, PhD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Chan Wai Sze, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04457440
Other Study ID Numbers:
  • EA1909037
  • UW20-245
First Posted:
Jul 7, 2020
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Chan Wai Sze, Assistant Professor, The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2021