Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04457440
• Other study ID #: EA1909037
• Secondary ID: UW20-245
• Status: Suspended
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Insomnia
• PreDiabetes
• Sleep Deprivation

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