PreDiabetesNCT04457440
Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes
A study testing Intensive Lifestyle Intervention and Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention in people with PreDiabetes and Insomnia, run by The University of Hong Kong at 2 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PreDiabetes, Insomnia, Sleep Deprivation
- What is being tested?
- Intensive Lifestyle Intervention and Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jul 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hpspital
Hong Kong
The University of Hong Kong
Hong Kong
About this study
Official title: A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes
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.
- Conditions
- PreDiabetes, Insomnia, Sleep Deprivation
- Being tested
- Intensive Lifestyle Intervention, Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention
- Keywords
- Cognitive Behavioral Therapy, Lifestyle Intervention
- Medical subject headings
- Prediabetic State, Sleep Initiation and Maintenance Disorders, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Lifestyle Intervention (ILI) | Active comparator | The ILI will consist of 8 group-based 90-min sessions focusing on modifying dietary and exercise habits with the goal of reducing 450kcal of daily calories and increasing physical activity to 150 minutes of exercise per week. Receives: Behavioral: Intensive Lifestyle Intervention |
| ILI enhanced with cognitive behavioral sleep intervention | Experimental | The ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session. Receives: Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1C (%)
Measured: 12 weeks from baseline
Changes in fasting glucose concentration (mg/dl)
Measured: 12 weeks from baseline
Changes in 2-hr oral glucose tolerance (mg/dl)
Measured: 12 weeks from baseline
Secondary outcomes (15)
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
Measured: 12 weeks from baseline
Changes in subjective sleep onset latency
measured by daily sleep diary
Measured: 12 weeks from baseline
Changes in subjective wake after sleep onset
measured by daily sleep diary
Measured: 12 weeks from baseline
Changes in subjective total sleep time
measured by daily sleep diary
Measured: 12 weeks from baseline
Changes in objective sleep onset latency
measured by actigraphy
Measured: 12 weeks from baseline
Changes in objective wake after sleep onset
measured by actigraphy
Measured: 12 weeks from baseline
Changes in objective total sleep time
measured by actigraphy
Measured: 12 weeks from baseline
Changes in body weight (kg)
Measured: 12 weeks from baseline
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
Measured: 12 weeks from baseline
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
Measured: 12 weeks from baseline
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
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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
Measured: 12 weeks from baseline
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
Measured: 12 weeks from baseline
Changes in dietary composition
Measured by the Chinese version of the 7-day Food Frequency Questionnaire
Measured: 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: COVID pandemic affected recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Wai Sze, The University of Hong Kong
- Investigators
- Wai Sze Chan, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457440
- Sponsor's protocol ID
- EA1909037
- Other IDs
- UW20-245
- Status last verified
- Oct 2021
- First submitted
- 26 Jun 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared with other researchers for review purposes.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04457440
- Acronym / sponsor ID
- EA1909037
- Conditions
- PreDiabetes, Insomnia, Sleep Deprivation
- Keywords
- Cognitive Behavioral Therapy, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID pandemic affected recruitment.
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Lifestyle Intervention (ILI) | Active comparator | Behavioral: Intensive Lifestyle InterventionThe ILI will consist of 8 group-based 90-min sessions focusing on modifying dietary and exercise habits with the goal of reducing 450kcal of daily calories and increasing physical activity to 150 minutes of exercise per week. |
| ILI enhanced with cognitive behavioral sleep intervention | Experimental | Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep InterventionThe ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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
Key exclusion criteria (5 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Lifestyle InterventionThis 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. | Behavioural | Intensive Lifestyle Intervention (ILI) |
| Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep InterventionThis 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. | Behavioural | ILI enhanced with cognitive behavioral sleep intervention |
Primary outcome
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
15 secondary outcomes
Changes in insomnia symptom severity
Time frame: 12 weeks from baseline
Changes in subjective sleep onset latency
Time frame: 12 weeks from baseline
Changes in subjective wake after sleep onset
Time frame: 12 weeks from baseline
Changes in subjective total sleep time
Time frame: 12 weeks from baseline
Changes in objective sleep onset latency
Time frame: 12 weeks from baseline
Changes in objective wake after sleep onset
Time frame: 12 weeks from baseline
Changes in objective total sleep time
Time frame: 12 weeks from baseline
Changes in body weight (kg)
Time frame: 12 weeks from baseline
Changes in psychological distress
Time frame: 12 weeks from baseline
Changes in quality of life
Time frame: 12 weeks from baseline
Changes in food craving
Time frame: 12 weeks from baseline
Changes in acceptance of physical activity
Time frame: 12 weeks from baseline
Changes in weight loss self efficacy
Time frame: 12 weeks from baseline
Changes in weight control strategies
Time frame: 12 weeks from baseline
Changes in dietary composition
Time frame: 12 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with other researchers for review purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Sze Chan, PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Lifestyle Intervention and Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention in people with PreDiabetes and Insomnia, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1C (%) (time frame: 12 weeks from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.