NCT04457440
Suspended
Not Applicable
A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PreDiabetes
- Sponsor
- The University of Hong Kong
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Changes in HbA1C (%)
- Status
- Suspended
- Last Updated
- 4 years ago
Overview
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.
Investigators
Dr. Chan Wai Sze
Assistant Professor
The University of Hong Kong
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
Outcomes
Primary Outcomes
Changes in HbA1C (%)
Time Frame: 12 weeks from baseline
Changes in fasting glucose concentration (mg/dl)
Time Frame: 12 weeks from baseline
Changes in 2-hr oral glucose tolerance (mg/dl)
Time Frame: 12 weeks from baseline
Secondary Outcomes
- Changes in subjective wake after sleep onset(12 weeks from baseline)
- Changes in objective sleep onset latency(12 weeks from baseline)
- Changes in dietary composition(12 weeks from baseline)
- Changes in subjective sleep onset latency(12 weeks from baseline)
- Changes in objective wake after sleep onset(12 weeks from baseline)
- Changes in objective total sleep time(12 weeks from baseline)
- Changes in acceptance of physical activity(12 weeks from baseline)
- Changes in weight loss self efficacy(12 weeks from baseline)
- Changes in insomnia symptom severity(12 weeks from baseline)
- Changes in subjective total sleep time(12 weeks from baseline)
- Changes in body weight (kg)(12 weeks from baseline)
- Changes in psychological distress(12 weeks from baseline)
- Changes in quality of life(12 weeks from baseline)
- Changes in food craving(12 weeks from baseline)
- Changes in weight control strategies(12 weeks from baseline)
Study Sites (2)
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