<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/NCT02979860</url>
  </required_header>
  <id_info>
    <org_study_id>24131</org_study_id>
    <nct_id>NCT02979860</nct_id>
  </id_info>
  <brief_title>Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk</brief_title>
  <official_title>Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</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>
      Enhancing children's sleep duration and/or timing may represent a novel approach for weight&#xD;
      regulation and prevention of T2DM. The proposed study will assess how experimental changes in&#xD;
      children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African&#xD;
      American children ages 8-11 years old who sleep approximately 9.5 hours or less each night&#xD;
      will be enrolled into a 4-arm randomized controlled pilot to compare three experimental&#xD;
      manipulations in children's sleep to a &quot;typical sleep&quot; (TYP) control. Experimental arms will&#xD;
      include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45&#xD;
      minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2-&#xD;
      and 4-week follow-up, participants be weighed and measured for height, have body fat assessed&#xD;
      (bod pod), and their blood drawn (following an overnight fast). The pilot will provide&#xD;
      important data on the potential role of sleep in combating disparities in cardiometabolic&#xD;
      risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose&#xD;
      regulation and 2) to determine the effect of changes in sleep on additional measures of&#xD;
      glucose regulation and adiposity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible families who provide consent/assent will be enrolled into a five week study. All&#xD;
      families will complete assessments at baseline, two weeks and four weeks. Each assessment&#xD;
      lasts one week and children will be asked to wear an actigraph on their wrist (to measure&#xD;
      sleep) and an accelerometer on their hip (to measure physical activity). At the end of the&#xD;
      week families will be scheduled for a visit at the research center first thing in the morning&#xD;
      approximately one hour after waking and following an overnight fast. During this visit,&#xD;
      actigraphs and accelerometers will be downloaded and data will be reviewed with families.&#xD;
      Children will be weighed and measured for height and have their body composition assessed. To&#xD;
      measure glucose regulation, children will first have 5 ml of blood drawn in a fasted state.&#xD;
      They will then ingest a glucose solution (1.75 g/kg; maximum of 75 g) over 2 minutes, and&#xD;
      blood will be drawn (1.5 ml) 120 min after the child consumes the solution. At week 4, 5 ml&#xD;
      blood will be drawn fasting; OGTT will not be administered (see note below). Research staff&#xD;
      will also complete one-day dietary recalls with participants at each center-based assessment&#xD;
      to obtain information on all foods consumed over the previous 24-hour period. In addition, at&#xD;
      the baseline assessment only, parents will complete questionnaires on basic demographic&#xD;
      information and child sleep. It is anticipated that the total time for each assessment will&#xD;
      take approximately 2.5-3 hours (1 hour at 4 weeks). Following eligibility confirmation at the&#xD;
      baseline assessment, families will be randomized to one of four protocols: 1) Enhance TIB by&#xD;
      90 min/night; 2) Enhance TIB by 45 min/night; 3) Regularize Sleep Schedule; or 4) Typical&#xD;
      Sleep Schedule.&#xD;
&#xD;
      Continuous glucose monitoring In a voluntary subset of randomly selected children&#xD;
      (approximately n = 4/group) 72-hour continuous glucose monitoring (CGM) will be performed. If&#xD;
      the child and family agree to participate in CGM, they will come to the Center for an&#xD;
      additional visit during which a disposable subcutaneous glucose-sensing device connected to a&#xD;
      battery-operated recorder will be inserted subcutaneously (a thin tube under the surface of&#xD;
      the skin). This sensor measures glucose every ten seconds and records an average value every&#xD;
      five minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 8, 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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin Resistance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fasting plasma insulin and glucose will be used to compute the homeostatic model assessment of insulin resistance (HOMA-IR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic Measures</measure>
    <time_frame>3 3-hour assessment visits</time_frame>
    <description>Blood will be drawn before and after the consumption of a glucose solution to compute an Insulin Sensitivity Index (ISI) and glucose tolerance.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Anthropometrics</measure>
    <time_frame>3 3-hour assessment visits</time_frame>
    <description>Child weight will be obtained on a digital scale and height on a wall-mounted stadiometer using standard procedures and while in street clothes, without shoes. Measures will be converted to BMI, BMIz, and BMI percentile using age and sex-adjusted normative data from the CDC.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body Composition</measure>
    <time_frame>3 3-hour assessment visits</time_frame>
    <description>Youth body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA).</description>
  </other_outcome>
  <other_outcome>
    <measure>Acceptability/Feasibility</measure>
    <time_frame>2 3-hour assesment Visit</time_frame>
    <description>Acceptability and feasibility of each experimental approach for changing sleep will be assessed with semi-structured qualitative interviews.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Type2 Diabetes</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Typical sleep schedule</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Children in this arm will be asked to maintain their current sleep schedule. No prescription will be provided other than to sleep how they &quot;typically&quot; would sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhance time in bed by 90 min/night</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sleep duration - 90 minutes: Children in this arm will be asked to get into bed and to turn their lights out 90 minutes earlier than their typical bedtime. Bedtimes and wake times will remain consistent across the 4-week experimental phase of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhance time in bed by 45 min/night</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sleep duration - 45 minutes:Children in this arm will be asked to get into bed and to turn their lights out 45 minutes earlier than their typical bedtime. Bedtimes and wake times will remain consistent across the 4-week experimental phase of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regularize sleep schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sleep timing: Children in this arm will be asked to get into bed at a consistent bedtime each night and wake at a consistent time each morning such that time in bed achieved during baseline is maintained during the 4-week experimental phase; only timing of bedtimes/wake times will be manipulated in this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep duration 90 min</intervention_name>
    <description>Sleep duration: time in bed increased by 90 minutes</description>
    <arm_group_label>Enhance time in bed by 90 min/night</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep duration 45 min</intervention_name>
    <description>Sleep duration: time in bed increased by 45 minutes</description>
    <arm_group_label>Enhance time in bed by 45 min/night</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep timing</intervention_name>
    <description>Sleep timing: bed time kept consistent</description>
    <arm_group_label>Regularize sleep schedule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parent-reported child race African American/Black.&#xD;
&#xD;
          2. Parent-reported child age of 8-11 years&#xD;
&#xD;
          3. Less than or equal to approximately 9.5 hours time in bed (TIB; based on actigraphy&#xD;
             and sleep diaries)&#xD;
&#xD;
          4. Variability in Sleep Patterns (based on actigraphy and sleep diaries)&#xD;
&#xD;
          5. BMI for age and gender &gt; 85th percentile (but no greater than 100% overweight)&#xD;
&#xD;
          6. Self-reported parent age of 18 years, primary caretaker, and at home throughout the&#xD;
             study (i.e., at bedtimes and wake times)&#xD;
&#xD;
          7. Reported willingness to complete all study tasks, including blood draws&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosable Sleep Disorder&#xD;
&#xD;
          2. Parent-reported diagnosis of medical or psychiatric condition that may impact&#xD;
             sleep/weight status&#xD;
&#xD;
          3. Actively trying to lose weight&#xD;
&#xD;
          4. Inability to Understand or Complete Protocol&#xD;
&#xD;
          5. Sibling of enrolled subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chantelle Hart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Obesity Research and Education, Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>October 22, 2021</last_update_submitted>
  <last_update_submitted_qc>October 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxymetazoline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02979860
org study id: 24131
nct id: NCT02979860
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Enhancing children's sleep duration and/or timing may represent a novel approach for weight
      regulation and prevention of T2DM. The proposed study will assess how experimental changes in
      children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African
      American children ages 8-11 years old who sleep approximately 9.5 hours or less each night
      will be enrolled into a 4-arm randomized controlled pilot to compare three experimental
      manipulations in children's sleep to a "typical sleep" (TYP) control. Experimental arms will
      include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45
      minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2-
      and 4-week follow-up, participants be weighed and measured for height, have body fat assessed
      (bod pod), and their blood drawn (following an overnight fast). The pilot will provide
      important data on the potential role of sleep in combating disparities in cardiometabolic
      risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose
      regulation and 2) to determine the effect of changes in sleep on additional measures of
      glucose regulation and adiposity.
Eligible families who provide consent/assent will be enrolled into a five week study. All
      families will complete assessments at baseline, two weeks and four weeks. Each assessment
      lasts one week and children will be asked to wear an actigraph on their wrist (to measure
      sleep) and an accelerometer on their hip (to measure physical activity). At the end of the
      week families will be scheduled for a visit at the research center first thing in the morning
      approximately one hour after waking and following an overnight fast. During this visit,
      actigraphs and accelerometers will be downloaded and data will be reviewed with families.
      Children will be weighed and measured for height and have their body composition assessed. To
      measure glucose regulation, children will first have 5 ml of blood drawn in a fasted state.
      They will then ingest a glucose solution (1.75 g/kg; maximum of 75 g) over 2 minutes, and
      blood will be drawn (1.5 ml) 120 min after the child consumes the solution. At week 4, 5 ml
      blood will be drawn fasting; OGTT will not be administered (see note below). Research staff
      will also complete one-day dietary recalls with participants at each center-based assessment
      to obtain information on all foods consumed over the previous 24-hour period. In addition, at
      the baseline assessment only, parents will complete questionnaires on basic demographic
      information and child sleep. It is anticipated that the total time for each assessment will
      take approximately 2.5-3 hours (1 hour at 4 weeks). Following eligibility confirmation at the
      baseline assessment, families will be randomized to one of four protocols: 1) Enhance TIB by
      90 min/night; 2) Enhance TIB by 45 min/night; 3) Regularize Sleep Schedule; or 4) Typical
      Sleep Schedule.

      Continuous glucose monitoring In a voluntary subset of randomly selected children
      (approximately n = 4/group) 72-hour continuous glucose monitoring (CGM) will be performed. If
      the child and family agree to participate in CGM, they will come to the Center for an
      additional visit during which a disposable subcutaneous glucose-sensing device connected to a
      battery-operated recorder will be inserted subcutaneously (a thin tube under the surface of
      the skin). This sensor measures glucose every ten seconds and records an average value every
      five minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Insulin Resistance
time frame: 4 weeks
description: Fasting plasma insulin and glucose will be used to compute the homeostatic model assessment of insulin resistance (HOMA-IR).
measure: Metabolic Measures
time frame: 3 3-hour assessment visits
description: Blood will be drawn before and after the consumption of a glucose solution to compute an Insulin Sensitivity Index (ISI) and glucose tolerance.
measure: Anthropometrics
time frame: 3 3-hour assessment visits
description: Child weight will be obtained on a digital scale and height on a wall-mounted stadiometer using standard procedures and while in street clothes, without shoes. Measures will be converted to BMI, BMIz, and BMI percentile using age and sex-adjusted normative data from the CDC.
measure: Body Composition
time frame: 3 3-hour assessment visits
description: Youth body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA).
measure: Acceptability/Feasibility
time frame: 2 3-hour assesment Visit
description: Acceptability and feasibility of each experimental approach for changing sleep will be assessed with semi-structured qualitative interviews.
arm group label: Typical sleep schedule
arm group type: No Intervention
description: Children in this arm will be asked to maintain their current sleep schedule. No prescription will be provided other than to sleep how they "typically" would sleep.
arm group label: Enhance time in bed by 90 min/night
arm group type: Experimental
description: Sleep duration - 90 minutes: Children in this arm will be asked to get into bed and to turn their lights out 90 minutes earlier than their typical bedtime. Bedtimes and wake times will remain consistent across the 4-week experimental phase of the study.
arm group label: Enhance time in bed by 45 min/night
arm group type: Experimental
description: Sleep duration - 45 minutes:Children in this arm will be asked to get into bed and to turn their lights out 45 minutes earlier than their typical bedtime. Bedtimes and wake times will remain consistent across the 4-week experimental phase of the study.
arm group label: Regularize sleep schedule
arm group type: Experimental
description: Sleep timing: Children in this arm will be asked to get into bed at a consistent bedtime each night and wake at a consistent time each morning such that time in bed achieved during baseline is maintained during the 4-week experimental phase; only timing of bedtimes/wake times will be manipulated in this arm.
intervention type: Behavioral
intervention name: Sleep duration 90 min
description: Sleep duration: time in bed increased by 90 minutes
arm group label: Enhance time in bed by 90 min/night
intervention type: Behavioral
intervention name: Sleep duration 45 min
description: Sleep duration: time in bed increased by 45 minutes
arm group label: Enhance time in bed by 45 min/night
intervention type: Behavioral
intervention name: Sleep timing
description: Sleep timing: bed time kept consistent
arm group label: Regularize sleep schedule
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chantelle Hart, PhD
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Oxymetazoline
sharing ipd: No