<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04457440</url>
  </required_header>
  <id_info>
    <org_study_id>EA1909037</org_study_id>
    <secondary_id>UW20-245</secondary_id>
    <nct_id>NCT04457440</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes</brief_title>
  <official_title>A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study aims to evaluate if improving sleep could enhance the intensive lifestyle&#xD;
      intervention for improving weight loss and glycemic control in prediabetic individuals who&#xD;
      have insomnia with short sleep duration. A cognitive behavioral intervention for insomnia&#xD;
      with adjustments aimed at increasing sleep duration (CBT-Sleep) will be used for this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    COVID pandemic affected recruitment.&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in HbA1C (%)</measure>
    <time_frame>12 weeks from baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in fasting glucose concentration (mg/dl)</measure>
    <time_frame>12 weeks from baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in 2-hr oral glucose tolerance (mg/dl)</measure>
    <time_frame>12 weeks from baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in insomnia symptom severity</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>measured by the Insomnia Severity Index. The score ranges from 0 to 28. The higher the score, the greater the symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in subjective sleep onset latency</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>measured by daily sleep diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in subjective wake after sleep onset</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>measured by daily sleep diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in subjective total sleep time</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>measured by daily sleep diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective sleep onset latency</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>measured by actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective wake after sleep onset</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>measured by actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in objective total sleep time</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>measured by actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight (kg)</measure>
    <time_frame>12 weeks from baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychological distress</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in food craving</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>Measured by the Food Craving Questionnaire. The score ranges from 10 to 70. The higher the score, the greater the food craving</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in acceptance of physical activity</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>Measured by the Physical Activity Acceptance and Action Questionnaire. The score ranges from 10 to 70. The higher the score, the greater acceptance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight loss self efficacy</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>Measured by the Weight Loss Self Efficacy Scale. The score ranges from 0 to 100%. The higher the percentage, the greater the self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight control strategies</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>Measured by the Weight Control Strategy Scale. The score ranges from 0 to 120. The higher the percentage, the more effective strategies are used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dietary composition</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>Measured by the Chinese version of the 7-day Food Frequency Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>PreDiabetes</condition>
  <condition>Insomnia</condition>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>Intensive Lifestyle Intervention (ILI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ILI enhanced with cognitive behavioral sleep intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Lifestyle Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Intensive Lifestyle Intervention (ILI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>ILI enhanced with cognitive behavioral sleep intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (a) Hong Kong residents,&#xD;
&#xD;
          -  (b) BMI &gt; 23kg/m2,&#xD;
&#xD;
          -  (c) aged 18 to 65 year-old,&#xD;
&#xD;
          -  (d) have prediabetes, defined by a plasma fasting glucose concentration of 5.6 to 6.9&#xD;
             mmol/L, impaired glucose tolerance (2hglucose 7.8-11.0 on OGTT), or HbA1c 5.7-6.4%,&#xD;
&#xD;
          -  (e) have average habitual sleep duration &lt; 6.5 hours, confirmed by actigraphy measure&#xD;
             of sleep for 2 weeks or have insomnia, confirmed in a clinical sleep interview and&#xD;
             actigraph-measure of greater than 30 minutes of sleep onset latency or nighttime&#xD;
             awakening for 3 nights or more per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (a) have unmanaged sleep apnea or other sleep disorders,&#xD;
&#xD;
          -  (b) have any current severe mental illnesses,&#xD;
&#xD;
          -  (c) have any medical conditions or medication use that could undermine the efficacy of&#xD;
             the sleep intervention,&#xD;
&#xD;
          -  (d) have shift work schedules,&#xD;
&#xD;
          -  (e) have any environmental constraints on the feasibility of implementing a sleep&#xD;
             schedule of at least 7.5 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wai Sze Chan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hpspital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 17, 2021</last_update_submitted>
  <last_update_submitted_qc>October 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Chan Wai Sze</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Lifestyle Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified data will be shared with other researchers for review purposes.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04457440
org study id: EA1909037
secondary id: UW20-245
nct id: NCT04457440
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in HbA1C (%)
time frame: 12 weeks from baseline
measure: Changes in fasting glucose concentration (mg/dl)
time frame: 12 weeks from baseline
measure: Changes in 2-hr oral glucose tolerance (mg/dl)
time frame: 12 weeks from baseline
measure: Changes in insomnia symptom severity
time frame: 12 weeks from baseline
description: measured by the Insomnia Severity Index. The score ranges from 0 to 28. The higher the score, the greater the symptom severity
measure: Changes in subjective sleep onset latency
time frame: 12 weeks from baseline
description: measured by daily sleep diary
measure: Changes in subjective wake after sleep onset
time frame: 12 weeks from baseline
description: measured by daily sleep diary
measure: Changes in subjective total sleep time
time frame: 12 weeks from baseline
description: measured by daily sleep diary
measure: Changes in objective sleep onset latency
time frame: 12 weeks from baseline
description: measured by actigraphy
measure: Changes in objective wake after sleep onset
time frame: 12 weeks from baseline
description: measured by actigraphy
measure: Changes in objective total sleep time
time frame: 12 weeks from baseline
description: measured by actigraphy
measure: Changes in body weight (kg)
time frame: 12 weeks from baseline
measure: Changes in psychological distress
time frame: 12 weeks from baseline
description: 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
measure: Changes in quality of life
time frame: 12 weeks from baseline
description: 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
measure: Changes in food craving
time frame: 12 weeks from baseline
description: Measured by the Food Craving Questionnaire. The score ranges from 10 to 70. The higher the score, the greater the food craving
measure: Changes in acceptance of physical activity
time frame: 12 weeks from baseline
description: Measured by the Physical Activity Acceptance and Action Questionnaire. The score ranges from 10 to 70. The higher the score, the greater acceptance.
measure: Changes in weight loss self efficacy
time frame: 12 weeks from baseline
description: Measured by the Weight Loss Self Efficacy Scale. The score ranges from 0 to 100%. The higher the percentage, the greater the self-efficacy
measure: Changes in weight control strategies
time frame: 12 weeks from baseline
description: Measured by the Weight Control Strategy Scale. The score ranges from 0 to 120. The higher the percentage, the more effective strategies are used
measure: Changes in dietary composition
time frame: 12 weeks from baseline
description: Measured by the Chinese version of the 7-day Food Frequency Questionnaire
arm group label: Intensive Lifestyle Intervention (ILI)
arm group type: Active Comparator
description: 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.
arm group label: ILI enhanced with cognitive behavioral sleep intervention
arm group type: Experimental
description: The ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session.
intervention type: Behavioral
intervention name: Intensive Lifestyle Intervention
description: 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.
arm group label: Intensive Lifestyle Intervention (ILI)
intervention type: Behavioral
intervention name: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention
description: 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.
arm group label: ILI enhanced with cognitive behavioral sleep intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wai Sze Chan, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Chan Wai Sze
investigator title: Assistant Professor
mesh term: Sleep Deprivation
sharing ipd: Yes
ipd description: Deidentified data will be shared with other researchers for review purposes.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)