<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/NCT03774563</url>
  </required_header>
  <id_info>
    <org_study_id>D19005</org_study_id>
    <nct_id>NCT03774563</nct_id>
  </id_info>
  <brief_title>Sleep During Weight Loss and Weight Loss Maintenance</brief_title>
  <official_title>Sleep During Weight Loss and Weight Loss Maintenance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine the changes of sleep during weight loss and weight&#xD;
      loss management. The research staff will also obtain data on sleep disturbances, insomnia&#xD;
      symptoms, risk of sleep apnea, circadian preferences, weight loss self-efficacy, emotional&#xD;
      eating, executive functioning, loneliness and social isolation, and patients' beliefs about&#xD;
      how sleep might impact their weight control or vice versa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an observational study using a longitudinal data collection design with&#xD;
      non-invasive measures. Fifty participants who are about to begin the Healthy Lifestyle&#xD;
      Program (HLP) at the Weight and Wellness Clinic (WWC) and another 50 participants who are&#xD;
      about to complete HLP will be recruited to the study. After informed consent is obtained, the&#xD;
      patient will be asked to complete several questionnaires about sleep and wellbeing. Their&#xD;
      height and weight will also be measured by the research staff. The patient will then be given&#xD;
      a wrist-worn accelerometer to wear for 16 weeks to measure their sleep and physical activity.&#xD;
      They will be asked to complete the same set of questions at approximately the 8th and 16th&#xD;
      week at a research visit. Data on existing diagnosis of sleep disorders will be extracted&#xD;
      from the patients' electronic medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">November 5, 2019</completion_date>
  <primary_completion_date type="Actual">November 5, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sleep duration</measure>
    <time_frame>Week 1 and 16th week</time_frame>
    <description>Sleep parameters measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. Measured in minutes of sleep per night. Higher number indicating longer sleep duration. Change from week 1 to week 16 will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in physical activity</measure>
    <time_frame>Week 1 and 16th week</time_frame>
    <description>Measured by the Actigraph model wGT3X-BT, a wrist accelerometer. Measured in minutes of moderate to vigorous activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sleep quality</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI) will be used to assess a range of sleep disturbances including insomnia, sleep-related breathing difficulties, and use of sleep aids. A total score of 5 or more is indicative of poor sleep quality. Possible score range is 0-21.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Severity of Insomnia</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>Insomnia Severity Index (ISI) will be used to assess the severity of insomnia symptoms and subjective daytime impairments.The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Risk for sleep apnea</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>The STOP-BANG Questionnaire will be used to assess the patient's risk for sleep apnea. Scores range from 0-8. The higher the score indicates an increase in the probability of sleep apnea.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Peak alertness</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>The Morningness-Eveningness Questionnaire (MEQ) will be used to assess whether the patient's circadian rhythm produces peak alertness in the morning or the evening. Multiple choice, 4-5 point scale. The sum gives a score ranging from 16 to 86; scores of 41 and below indicate &quot;evening types&quot;, scores of 59 and above indicate &quot;morning types&quot;, scores between 42-58 indicate &quot;intermediate types&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-efficacy in one's ability to lose or maintain weight</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>The Weight Loss Self-Efficacy Scale will be used to assess self-efficacy in one's ability to lose or maintain weight. Measured by subjective rating percentages of confidence, 0-100%. The higher the percentage the higher the ability to maintain or lose weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in strategies to lose weight</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>The Weight Control Strategies Scale will be used to assess strategies used to lose weight. The sum of scores ranges from 0-120. The higher the scores the more strategies being used to lose weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in emotional and disinhibited eating</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>Three Factors Eating Questionnaire will be used to measure emotional and disinhibited eating. Comprised of 18 items , which are aggregated to three separate scale scores. A 4-point response format is used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mood symptoms</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>will be assessed using the Patient Healthy Questionnaire (PHQ9). The PHQ9 scores range from 0-27, with lower numbers indicating minimal to no depression and higher numbers indicating severe depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Delayed Discounting Index</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>Executive functioning will be assessed using the delay discounting task and the response disinhibition task. K index corresponding to the degree to which a participant discounts future rewards compared to immediate rewards. Will be computed based on a validated algorithm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in social isolation</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>Social isolation will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) isolation scale. The PROMIS scale has six items each with a response options ranging in value from one to five. The lowest possible score is 6 and highest possible score is 30.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>Week 1, 8th week, and 16th week</time_frame>
    <description>will be assessed using the Generalized Anxiety Disorder-7 (GAD7). The GAD7 scores range from 5-21, with 5-9 indicating mild, 10-14 moderate, and greater than 15 severe anxiety.</description>
  </primary_outcome>
  <enrollment type="Actual">32</enrollment>
  <condition>Sleep</condition>
  <condition>Weight Loss</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who are about to begin the Healthy Lifestyle Program at the Weight and Wellness&#xD;
        Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult overweight or obese patients who are enrolled in or who completed the Healthy&#xD;
             Lifestyle Program at Weight and Wellness Center.Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Wai S Chan, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sivan Rotenberg, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jessica K Salwen-Deremer, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Jessica.K.Salwen-Deremer</investigator_full_name>
    <investigator_title>Clinical Psychologist, Phd</investigator_title>
  </responsible_party>
  <keyword>weight loss</keyword>
  <keyword>sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03774563/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03774563
org study id: D19005
nct id: NCT03774563
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to examine the changes of sleep during weight loss and weight
      loss management. The research staff will also obtain data on sleep disturbances, insomnia
      symptoms, risk of sleep apnea, circadian preferences, weight loss self-efficacy, emotional
      eating, executive functioning, loneliness and social isolation, and patients' beliefs about
      how sleep might impact their weight control or vice versa.
This study is an observational study using a longitudinal data collection design with
      non-invasive measures. Fifty participants who are about to begin the Healthy Lifestyle
      Program (HLP) at the Weight and Wellness Clinic (WWC) and another 50 participants who are
      about to complete HLP will be recruited to the study. After informed consent is obtained, the
      patient will be asked to complete several questionnaires about sleep and wellbeing. Their
      height and weight will also be measured by the research staff. The patient will then be given
      a wrist-worn accelerometer to wear for 16 weeks to measure their sleep and physical activity.
      They will be asked to complete the same set of questions at approximately the 8th and 16th
      week at a research visit. Data on existing diagnosis of sleep disorders will be extracted
      from the patients' electronic medical records.
observational model: Cohort
time perspective: Prospective
measure: Change in sleep duration
time frame: Week 1 and 16th week
description: Sleep parameters measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. Measured in minutes of sleep per night. Higher number indicating longer sleep duration. Change from week 1 to week 16 will be measured.
measure: Changes in physical activity
time frame: Week 1 and 16th week
description: Measured by the Actigraph model wGT3X-BT, a wrist accelerometer. Measured in minutes of moderate to vigorous activity.
measure: Change in sleep quality
time frame: Week 1, 8th week, and 16th week
description: Pittsburgh Sleep Quality Index (PSQI) will be used to assess a range of sleep disturbances including insomnia, sleep-related breathing difficulties, and use of sleep aids. A total score of 5 or more is indicative of poor sleep quality. Possible score range is 0-21.
measure: Change in Severity of Insomnia
time frame: Week 1, 8th week, and 16th week
description: Insomnia Severity Index (ISI) will be used to assess the severity of insomnia symptoms and subjective daytime impairments.The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.
measure: Change in Risk for sleep apnea
time frame: Week 1, 8th week, and 16th week
description: The STOP-BANG Questionnaire will be used to assess the patient's risk for sleep apnea. Scores range from 0-8. The higher the score indicates an increase in the probability of sleep apnea.
measure: Change in Peak alertness
time frame: Week 1, 8th week, and 16th week
description: The Morningness-Eveningness Questionnaire (MEQ) will be used to assess whether the patient's circadian rhythm produces peak alertness in the morning or the evening. Multiple choice, 4-5 point scale. The sum gives a score ranging from 16 to 86; scores of 41 and below indicate "evening types", scores of 59 and above indicate "morning types", scores between 42-58 indicate "intermediate types".
measure: Change in self-efficacy in one's ability to lose or maintain weight
time frame: Week 1, 8th week, and 16th week
description: The Weight Loss Self-Efficacy Scale will be used to assess self-efficacy in one's ability to lose or maintain weight. Measured by subjective rating percentages of confidence, 0-100%. The higher the percentage the higher the ability to maintain or lose weight.
measure: Change in strategies to lose weight
time frame: Week 1, 8th week, and 16th week
description: The Weight Control Strategies Scale will be used to assess strategies used to lose weight. The sum of scores ranges from 0-120. The higher the scores the more strategies being used to lose weight.
measure: Change in emotional and disinhibited eating
time frame: Week 1, 8th week, and 16th week
description: Three Factors Eating Questionnaire will be used to measure emotional and disinhibited eating. Comprised of 18 items , which are aggregated to three separate scale scores. A 4-point response format is used.
measure: Mood symptoms
time frame: Week 1, 8th week, and 16th week
description: will be assessed using the Patient Healthy Questionnaire (PHQ9). The PHQ9 scores range from 0-27, with lower numbers indicating minimal to no depression and higher numbers indicating severe depression.
measure: Change in Delayed Discounting Index
time frame: Week 1, 8th week, and 16th week
description: Executive functioning will be assessed using the delay discounting task and the response disinhibition task. K index corresponding to the degree to which a participant discounts future rewards compared to immediate rewards. Will be computed based on a validated algorithm.
measure: Change in social isolation
time frame: Week 1, 8th week, and 16th week
description: Social isolation will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) isolation scale. The PROMIS scale has six items each with a response options ranging in value from one to five. The lowest possible score is 6 and highest possible score is 30.
measure: Anxiety symptoms
time frame: Week 1, 8th week, and 16th week
description: will be assessed using the Generalized Anxiety Disorder-7 (GAD7). The GAD7 scores range from 5-21, with 5-9 indicating mild, 10-14 moderate, and greater than 15 severe anxiety.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Wai S Chan, Phd
role: Principal Investigator
affiliation: Dartmouth College
last name: Sivan Rotenberg, Phd
role: Principal Investigator
affiliation: Dartmouth College
last name: Jessica K Salwen-Deremer, Phd
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Jessica.K.Salwen-Deremer
investigator title: Clinical Psychologist, Phd
mesh term: Body Weight
mesh term: Weight Loss
provided document: 