Insomnia, PreDiabetes, Sleep Deprivation
Conditions
Keywords
Cognitive Behavioral Therapy, Lifestyle Intervention
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.
Interventions
BEHAVIORALIntensive 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.
BEHAVIORALIntensive 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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1C (%) | 12 weeks from baseline |
| Changes in fasting glucose concentration (mg/dl) | 12 weeks from baseline |
| Changes in 2-hr oral glucose tolerance (mg/dl) | 12 weeks from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Changes in subjective sleep onset latency | 12 weeks from baseline | measured by daily sleep diary |
| Changes in subjective wake after sleep onset | 12 weeks from baseline | measured by daily sleep diary |
| Changes in subjective total sleep time | 12 weeks from baseline | measured by daily sleep diary |
| Changes in objective sleep onset latency | 12 weeks from baseline | measured by actigraphy |
| Changes in objective wake after sleep onset | 12 weeks from baseline | measured by actigraphy |
| 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. |
| Changes in body weight (kg) | 12 weeks from baseline | — |
| 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 |
| 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 |
| 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 |
| Changes in dietary composition | 12 weeks from baseline | Measured by the Chinese version of the 7-day Food Frequency Questionnaire |
| Changes in objective total sleep time | 12 weeks from baseline | measured by actigraphy |
| 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 |
| 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 |
Countries
Hong Kong
Outcome results
None listed