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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04457440
Other study ID # EA1909037
Secondary ID UW20-245
Status Suspended
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date December 30, 2021

Study information

Verified date October 2021
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 36
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Hong Kong Queen Mary Hpspital Hong Kong
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in HbA1C (%) 12 weeks from baseline
Primary Changes in fasting glucose concentration (mg/dl) 12 weeks from baseline
Primary Changes in 2-hr oral glucose tolerance (mg/dl) 12 weeks from baseline
Secondary 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 12 weeks from baseline
Secondary Changes in subjective sleep onset latency measured by daily sleep diary 12 weeks from baseline
Secondary Changes in subjective wake after sleep onset measured by daily sleep diary 12 weeks from baseline
Secondary Changes in subjective total sleep time measured by daily sleep diary 12 weeks from baseline
Secondary Changes in objective sleep onset latency measured by actigraphy 12 weeks from baseline
Secondary Changes in objective wake after sleep onset measured by actigraphy 12 weeks from baseline
Secondary Changes in objective total sleep time measured by actigraphy 12 weeks from baseline
Secondary Changes in body weight (kg) 12 weeks from baseline
Secondary 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 12 weeks from baseline
Secondary 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 12 weeks from baseline
Secondary 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 12 weeks from baseline
Secondary 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. 12 weeks from baseline
Secondary 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 12 weeks from baseline
Secondary 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 12 weeks from baseline
Secondary Changes in dietary composition Measured by the Chinese version of the 7-day Food Frequency Questionnaire 12 weeks from baseline
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