Clinical trial NCT04457440: 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
Overall status: SUSPENDED
Phase: NA
Conditions: PreDiabetes
Insomnia
Sleep Deprivation
Keywords: Cognitive Behavioral Therapy
Lifestyle Intervention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in HbA1C (%)
timeFrame: 12 weeks from baseline
measure: Changes in fasting glucose concentration (mg/dl)
timeFrame: 12 weeks from baseline
measure: Changes in 2-hr oral glucose tolerance (mg/dl)
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Changes in insomnia symptom severity
timeFrame: 12 weeks from baseline
measure: Changes in subjective sleep onset latency
timeFrame: 12 weeks from baseline
measure: Changes in subjective wake after sleep onset
timeFrame: 12 weeks from baseline
measure: Changes in subjective total sleep time
timeFrame: 12 weeks from baseline
measure: Changes in objective sleep onset latency
timeFrame: 12 weeks from baseline
measure: Changes in objective wake after sleep onset
timeFrame: 12 weeks from baseline
measure: Changes in objective total sleep time
timeFrame: 12 weeks from baseline
measure: Changes in body weight (kg)
timeFrame: 12 weeks from baseline
measure: Changes in psychological distress
timeFrame: 12 weeks from baseline
measure: Changes in quality of life
timeFrame: 12 weeks from baseline
measure: Changes in food craving
timeFrame: 12 weeks from baseline
measure: Changes in acceptance of physical activity
timeFrame: 12 weeks from baseline
measure: Changes in weight loss self efficacy
timeFrame: 12 weeks from baseline
measure: Changes in weight control strategies
timeFrame: 12 weeks from baseline
measure: Changes in dietary composition
timeFrame: 12 weeks from baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hpspital
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Wai Sze Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: