<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/NCT04469790</url>
  </required_header>
  <id_info>
    <org_study_id>R01DK123333</org_study_id>
    <nct_id>NCT04469790</nct_id>
  </id_info>
  <brief_title>Effects of Multi-day Interruptions in Sitting on Type 2 Diabetes-relevant Outcomes in Children</brief_title>
  <official_title>Testing the Efficacy of Multi-day Interruptions in Sedentary Behaviors on Metabolic, Cognitive, and Affective Outcomes in Youth at Risk for Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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 overall objective of this in-lab randomized controlled trial is to test the efficacy of&#xD;
      multi-day interruptions in sedentary behavior vs. single bouts of sustained exercise on&#xD;
      metabolic, cognitive, affective, and cardiac autonomic nervous system responses in children&#xD;
      with overweight and obesity who are at risk for type 2 diabetes. The use of continuous&#xD;
      glucose monitoring will provide insight into the daily and cumulative metabolic effects of&#xD;
      each condition that have thus far not been studied. In-lab studies demonstrating sustained&#xD;
      efficacy of this approach in ameliorating negative effects of sedentary behaviors in children&#xD;
      are necessary for the optimization of field-based interventions. Given the lack of success of&#xD;
      interventions to prevent obesity-related diseases and increasing rates of type 2 diabetes in&#xD;
      children and its related healthcare costs, this study addresses a critical public health need&#xD;
      by testing of novel intervention strategies to reduce obesity-related diseases in children&#xD;
      with overweight and obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Sedentary behavior (SB) contributes to increased risk for obesity and metabolic&#xD;
      disease, cognitive deficits, affect disorders, and cardiovascular disease over the lifespan.&#xD;
      These are critical outcomes because children with these risk factors are more likely to&#xD;
      develop type 2 diabetes mellitus (T2DM). SB increases T2DM risk by promoting hyperglycemia&#xD;
      and greater postprandial glycemic variability as well as via cognitive detriments and&#xD;
      depressive symptoms that lead to poor energy balance behaviors, obesity, and worsening&#xD;
      insulin resistance. Additionally, prolonged SB may contribute to dominance of the sympathetic&#xD;
      nervous system and lead to poor cardiovascular disease outcomes. Physical activity can reduce&#xD;
      these risk factors, however less than half of US youth meet guideline recommendations, and&#xD;
      physical activity continues to decline throughout adolescence. Thus, there is a critical need&#xD;
      to test alternative intervention approaches to sustained bouts of exercise for the prevention&#xD;
      of T2DM in children. The investigators were the first to show that interrupting SB with&#xD;
      short, 3-minute, bouts of moderate exercise improved glucose tolerance and negative mood in a&#xD;
      single 3-hour session. However, it is unknown whether these short-term improvements translate&#xD;
      to sustained multi-day benefits to metabolic, cognitive, mood, and cardiac autonomic nervous&#xD;
      system outcomes.&#xD;
&#xD;
      Intervention: This phase II randomized controlled trial (RCT) will compare the effects of SB&#xD;
      interruptions vs. sustained bouts of exercise to prolonged sitting in 7-11-year-old children&#xD;
      with overweight/obesity. Participants (N=150 (50 per group); ages 7-11) will be recruited&#xD;
      from the community and the Children's Hospital Los Angeles (CHLA) pediatric obesity clinic.&#xD;
      The participants will wear continuous glucose monitors for one week and complete pre- and&#xD;
      post- experiment 3-hour oral glucose tolerance tests (OGTT). Children will be randomized to 7&#xD;
      consecutive days of one of the following 3-hour experimental conditions: a) continuous&#xD;
      sitting (SIT); b) sitting interrupted by 3-minute bouts of moderate-intensity walking every&#xD;
      30 minutes (SIT+WALK); or c) a single 18-minute bout of moderate-intensity walking followed&#xD;
      by continuous sitting (EX).&#xD;
&#xD;
      Objectives/Purpose: The overall goal of this study is to test the efficacy of multi-day&#xD;
      effects of interrupting SB as a T2DM prevention strategy in youth with overweight/obesity.&#xD;
      This proposal will address the following aims: (1) determine the multi-day efficacy of&#xD;
      interrupting sitting on glucose homeostasis measured by continuous glucose monitor and oral&#xD;
      glucose tolerance tests; (2) determine the multi-day efficacy of interrupting sitting on&#xD;
      cognitive function improvements; (3) determine the multi-day efficacy of interrupting sitting&#xD;
      on affect and anxiety improvements; and (4) determine the multi-day efficacy of interrupting&#xD;
      sitting on cardiac autonomic nervous system improvements measured by heart rate variability.&#xD;
&#xD;
      Study Population: The study population will consist of children with overweight/obesity&#xD;
      recruited from the greater Los Angeles area and the CHLA pediatric obesity clinic. Children&#xD;
      will be screened for eligibility (no evidence of type 2 diabetes, have overweight/obesity, be&#xD;
      in good health, and be in early pubertal stages).&#xD;
&#xD;
      Study Methodology: This study is a phase II RCT with 3 study arms. Participants (N=150) will&#xD;
      complete one screening visit to determine eligibility, complete a fitness test, and body&#xD;
      composition analysis via dual x-ray absorptiometry (DEXA). All participants will complete two&#xD;
      3-hour in-lab oral glucose tolerance tests (spaced 6 days apart). Participants will wear an&#xD;
      activity monitor on the right thigh and an electrocardiogram (ECG) monitor on the chest 7&#xD;
      days to determine baseline activity levels and heart rate variability, respectively. Then,&#xD;
      participants will complete 7 consecutive in-lab sessions (SIT, SIT+WALK, or EX), with a&#xD;
      3-hour OGTT on Days 1 and 7. Participants will wear activity monitors, continuous glucose&#xD;
      monitors, and ECG monitors during these 7 days of experimental sessions. Questionnaires will&#xD;
      assess dietary intake, affect, anxiety, and mood, and the NIH Toolbox will assess executive&#xD;
      cognitive function.&#xD;
&#xD;
      Study Arms: Participants will be randomized to 7 consecutive days of one of the following&#xD;
      3-hour experimental conditions in the lab: a) continuous sitting (SIT); b) sitting&#xD;
      interrupted by 3-minute bouts of moderate-intensity walking every 30 minutes (SIT+WALK); or&#xD;
      c) a single 18-minute bout of moderate-intensity walking followed by continuous sitting (EX).&#xD;
&#xD;
      Endpoints/Outcomes: The primary endpoints are: insulin, C-peptide, and glucose area under the&#xD;
      curve (AUC) in the in-lab experiments, and glucose AUC from the continuous glucose monitor.&#xD;
      Secondary endpoints are positive and negative affect, anxiety, executive cognitive function,&#xD;
      and heart rate variability metrics.&#xD;
&#xD;
      Follow-up: Study duration is estimated as 14 days minimum and 30 days maximum, to allow for a&#xD;
      7-21 day period between the screening and experimental visits.&#xD;
&#xD;
      Statistical Analyses: The populations for analyses include the full analytical dataset which&#xD;
      consists of all randomized study participants; the investigators will employ per protocol and&#xD;
      intent to treat analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2022</start_date>
  <completion_date type="Anticipated">May 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2026</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>
    <intervention_model_description>Randomized parallel-arm clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In-Lab glucose area under the curve (AUC)</measure>
    <time_frame>3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7</time_frame>
    <description>change in glucose AUC from oral glucose tolerance tests</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-Lab insulin area under the curve (AUC)</measure>
    <time_frame>3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7</time_frame>
    <description>change in insulin AUC from oral glucose tolerance tests</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-Lab c-peptide area under the curve (AUC)</measure>
    <time_frame>3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7</time_frame>
    <description>change in c-peptide AUC from oral glucose tolerance tests</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Continuous glucose monitor measures</measure>
    <time_frame>7 days</time_frame>
    <description>mean daily 24-hr glucose area under the curve (AUC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive function measures</measure>
    <time_frame>change from Day 1 to Day 7</time_frame>
    <description>attention, inhibition, working and episodic memory tasks from NIH Toolbox</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Scale for Children</measure>
    <time_frame>change from Day 1 to Day 7</time_frame>
    <description>10-item positive and negative affect scale with scores for each ranging from 0 to 5, higher scores indicating worse outcome for negative affect and better outcome for positive affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory for Children (STAIC)</measure>
    <time_frame>change from Day 1 to Day 7</time_frame>
    <description>state anxiety will be measured using the STAIC, with a range from 20 to 80 with higher scores indicating more anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac autonomic nervous system measures</measure>
    <time_frame>7 days</time_frame>
    <description>mean daily heart rate variability metrics, including standard deviation of R-R intervals, root mean square of RR interval differences, high frequency, low frequency, and high to low frequency ratio</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Sedentary Behavior</condition>
  <condition>Affect</condition>
  <condition>Metabolic Disturbance</condition>
  <condition>Anxiety</condition>
  <condition>Cardiac Autonomic Nervous System Function</condition>
  <arm_group>
    <arm_group_label>SIT</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Continuous sitting for 3 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIT+WALK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interrupt sitting with 3-minutes of moderate-intensity walking every 30 minutes for 3 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perform 18 consecutive minutes of moderate-intensity walking, then sit for the remaining time</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SIT+WALK</intervention_name>
    <description>Participants will interrupt their sitting for one week</description>
    <arm_group_label>SIT+WALK</arm_group_label>
    <other_name>Interrupted sitting</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EX</intervention_name>
    <description>Participants will perform a single bout of exercise and then sit for the remaining time for one week</description>
    <arm_group_label>EX</arm_group_label>
    <other_name>Sustained exercise</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 7-11 years-old&#xD;
&#xD;
          2. Good general health&#xD;
&#xD;
          3. Fasting plasma glucose &lt; 100 mg/dL&#xD;
&#xD;
          4. BMI≥85th percentile&#xD;
&#xD;
          5. Pre- or peri-puberty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or&#xD;
             decreased perfusion&#xD;
&#xD;
          2. Evidence of impaired glucose tolerance or T2DM, presence of other endocrinologic&#xD;
             disorders leading to obesity (e.g., Cushing Syndrome)&#xD;
&#xD;
          3. Current or past anti-psychotic drug use that would affect metabolism&#xD;
&#xD;
          4. Non-diet treatment for hypertension or dyslipidemia&#xD;
&#xD;
          5. Precocious puberty and/or receiving androgen and estrogen therapy&#xD;
&#xD;
          6. Medication use known to affect body composition/weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Britni Ryan Belcher, PhD, MPH</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Britni R Belcher, PhD, MPH</last_name>
      <phone>323-442-8225</phone>
      <email>bbelcher@usc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Belcher BR, Berrigan D, Papachristopoulou A, Brady SM, Bernstein SB, Brychta RJ, Hattenbach JD, Tigner IL Jr, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. Effects of Interrupting Children's Sedentary Behaviors With Activity on Metabolic Function: A Randomized Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3735-43. doi: 10.1210/jc.2015-2803. Epub 2015 Aug 27.</citation>
    <PMID>26312582</PMID>
  </reference>
  <reference>
    <citation>Broadney MM, Belcher BR, Berrigan DA, Brychta RJ, Tigner IL Jr, Shareef F, Papachristopoulou A, Hattenbach JD, Davis EK, Brady SM, Bernstein SB, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. Effects of Interrupting Sedentary Behavior With Short Bouts of Moderate Physical Activity on Glucose Tolerance in Children With Overweight and Obesity: A Randomized Crossover Trial. Diabetes Care. 2018 Oct;41(10):2220-2228. doi: 10.2337/dc18-0774. Epub 2018 Aug 6.</citation>
    <PMID>30082324</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Britni Ryan Belcher, PhD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>cognitive functions</keyword>
  <keyword>continuous glucose monitoring</keyword>
  <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/NCT04469790
org study id: R01DK123333
nct id: NCT04469790
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall objective of this in-lab randomized controlled trial is to test the efficacy of
      multi-day interruptions in sedentary behavior vs. single bouts of sustained exercise on
      metabolic, cognitive, affective, and cardiac autonomic nervous system responses in children
      with overweight and obesity who are at risk for type 2 diabetes. The use of continuous
      glucose monitoring will provide insight into the daily and cumulative metabolic effects of
      each condition that have thus far not been studied. In-lab studies demonstrating sustained
      efficacy of this approach in ameliorating negative effects of sedentary behaviors in children
      are necessary for the optimization of field-based interventions. Given the lack of success of
      interventions to prevent obesity-related diseases and increasing rates of type 2 diabetes in
      children and its related healthcare costs, this study addresses a critical public health need
      by testing of novel intervention strategies to reduce obesity-related diseases in children
      with overweight and obesity.
Rationale: Sedentary behavior (SB) contributes to increased risk for obesity and metabolic
      disease, cognitive deficits, affect disorders, and cardiovascular disease over the lifespan.
      These are critical outcomes because children with these risk factors are more likely to
      develop type 2 diabetes mellitus (T2DM). SB increases T2DM risk by promoting hyperglycemia
      and greater postprandial glycemic variability as well as via cognitive detriments and
      depressive symptoms that lead to poor energy balance behaviors, obesity, and worsening
      insulin resistance. Additionally, prolonged SB may contribute to dominance of the sympathetic
      nervous system and lead to poor cardiovascular disease outcomes. Physical activity can reduce
      these risk factors, however less than half of US youth meet guideline recommendations, and
      physical activity continues to decline throughout adolescence. Thus, there is a critical need
      to test alternative intervention approaches to sustained bouts of exercise for the prevention
      of T2DM in children. The investigators were the first to show that interrupting SB with
      short, 3-minute, bouts of moderate exercise improved glucose tolerance and negative mood in a
      single 3-hour session. However, it is unknown whether these short-term improvements translate
      to sustained multi-day benefits to metabolic, cognitive, mood, and cardiac autonomic nervous
      system outcomes.

      Intervention: This phase II randomized controlled trial (RCT) will compare the effects of SB
      interruptions vs. sustained bouts of exercise to prolonged sitting in 7-11-year-old children
      with overweight/obesity. Participants (N=150 (50 per group); ages 7-11) will be recruited
      from the community and the Children's Hospital Los Angeles (CHLA) pediatric obesity clinic.
      The participants will wear continuous glucose monitors for one week and complete pre- and
      post- experiment 3-hour oral glucose tolerance tests (OGTT). Children will be randomized to 7
      consecutive days of one of the following 3-hour experimental conditions: a) continuous
      sitting (SIT); b) sitting interrupted by 3-minute bouts of moderate-intensity walking every
      30 minutes (SIT+WALK); or c) a single 18-minute bout of moderate-intensity walking followed
      by continuous sitting (EX).

      Objectives/Purpose: The overall goal of this study is to test the efficacy of multi-day
      effects of interrupting SB as a T2DM prevention strategy in youth with overweight/obesity.
      This proposal will address the following aims: (1) determine the multi-day efficacy of
      interrupting sitting on glucose homeostasis measured by continuous glucose monitor and oral
      glucose tolerance tests; (2) determine the multi-day efficacy of interrupting sitting on
      cognitive function improvements; (3) determine the multi-day efficacy of interrupting sitting
      on affect and anxiety improvements; and (4) determine the multi-day efficacy of interrupting
      sitting on cardiac autonomic nervous system improvements measured by heart rate variability.

      Study Population: The study population will consist of children with overweight/obesity
      recruited from the greater Los Angeles area and the CHLA pediatric obesity clinic. Children
      will be screened for eligibility (no evidence of type 2 diabetes, have overweight/obesity, be
      in good health, and be in early pubertal stages).

      Study Methodology: This study is a phase II RCT with 3 study arms. Participants (N=150) will
      complete one screening visit to determine eligibility, complete a fitness test, and body
      composition analysis via dual x-ray absorptiometry (DEXA). All participants will complete two
      3-hour in-lab oral glucose tolerance tests (spaced 6 days apart). Participants will wear an
      activity monitor on the right thigh and an electrocardiogram (ECG) monitor on the chest 7
      days to determine baseline activity levels and heart rate variability, respectively. Then,
      participants will complete 7 consecutive in-lab sessions (SIT, SIT+WALK, or EX), with a
      3-hour OGTT on Days 1 and 7. Participants will wear activity monitors, continuous glucose
      monitors, and ECG monitors during these 7 days of experimental sessions. Questionnaires will
      assess dietary intake, affect, anxiety, and mood, and the NIH Toolbox will assess executive
      cognitive function.

      Study Arms: Participants will be randomized to 7 consecutive days of one of the following
      3-hour experimental conditions in the lab: a) continuous sitting (SIT); b) sitting
      interrupted by 3-minute bouts of moderate-intensity walking every 30 minutes (SIT+WALK); or
      c) a single 18-minute bout of moderate-intensity walking followed by continuous sitting (EX).

      Endpoints/Outcomes: The primary endpoints are: insulin, C-peptide, and glucose area under the
      curve (AUC) in the in-lab experiments, and glucose AUC from the continuous glucose monitor.
      Secondary endpoints are positive and negative affect, anxiety, executive cognitive function,
      and heart rate variability metrics.

      Follow-up: Study duration is estimated as 14 days minimum and 30 days maximum, to allow for a
      7-21 day period between the screening and experimental visits.

      Statistical Analyses: The populations for analyses include the full analytical dataset which
      consists of all randomized study participants; the investigators will employ per protocol and
      intent to treat analyses.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized parallel-arm clinical trial
primary purpose: Prevention
masking: None (Open Label)
measure: In-Lab glucose area under the curve (AUC)
time frame: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7
description: change in glucose AUC from oral glucose tolerance tests
measure: In-Lab insulin area under the curve (AUC)
time frame: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7
description: change in insulin AUC from oral glucose tolerance tests
measure: In-Lab c-peptide area under the curve (AUC)
time frame: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7
description: change in c-peptide AUC from oral glucose tolerance tests
measure: Continuous glucose monitor measures
time frame: 7 days
description: mean daily 24-hr glucose area under the curve (AUC)
measure: Cognitive function measures
time frame: change from Day 1 to Day 7
description: attention, inhibition, working and episodic memory tasks from NIH Toolbox
measure: Positive and Negative Affect Scale for Children
time frame: change from Day 1 to Day 7
description: 10-item positive and negative affect scale with scores for each ranging from 0 to 5, higher scores indicating worse outcome for negative affect and better outcome for positive affect
measure: State-Trait Anxiety Inventory for Children (STAIC)
time frame: change from Day 1 to Day 7
description: state anxiety will be measured using the STAIC, with a range from 20 to 80 with higher scores indicating more anxiety
measure: Cardiac autonomic nervous system measures
time frame: 7 days
description: mean daily heart rate variability metrics, including standard deviation of R-R intervals, root mean square of RR interval differences, high frequency, low frequency, and high to low frequency ratio
arm group label: SIT
arm group type: No Intervention
description: Continuous sitting for 3 hours
arm group label: SIT+WALK
arm group type: Experimental
description: Interrupt sitting with 3-minutes of moderate-intensity walking every 30 minutes for 3 hours
arm group label: EX
arm group type: Experimental
description: Perform 18 consecutive minutes of moderate-intensity walking, then sit for the remaining time
intervention type: Behavioral
intervention name: SIT+WALK
description: Participants will interrupt their sitting for one week
arm group label: SIT+WALK
other name: Interrupted sitting
intervention type: Behavioral
intervention name: EX
description: Participants will perform a single bout of exercise and then sit for the remaining time for one week
arm group label: EX
other name: Sustained exercise
criteria: 
gender: All
minimum age: 7 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: United States
citation: Belcher BR, Berrigan D, Papachristopoulou A, Brady SM, Bernstein SB, Brychta RJ, Hattenbach JD, Tigner IL Jr, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. Effects of Interrupting Children's Sedentary Behaviors With Activity on Metabolic Function: A Randomized Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3735-43. doi: 10.1210/jc.2015-2803. Epub 2015 Aug 27.
PMID: 26312582
citation: Broadney MM, Belcher BR, Berrigan DA, Brychta RJ, Tigner IL Jr, Shareef F, Papachristopoulou A, Hattenbach JD, Davis EK, Brady SM, Bernstein SB, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. Effects of Interrupting Sedentary Behavior With Short Bouts of Moderate Physical Activity on Glucose Tolerance in Children With Overweight and Obesity: A Randomized Crossover Trial. Diabetes Care. 2018 Oct;41(10):2220-2228. doi: 10.2337/dc18-0774. Epub 2018 Aug 6.
PMID: 30082324
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Britni Ryan Belcher, PhD, MPH
investigator title: Assistant Professor
sharing ipd: No