<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/NCT04499547</url>
  </required_header>
  <id_info>
    <org_study_id>2728</org_study_id>
    <nct_id>NCT04499547</nct_id>
  </id_info>
  <brief_title>YouTube-Delivered Physical Activity Intervention</brief_title>
  <official_title>Effect of a YouTube-Delivered Physical Activity Intervention on College Students' Aerobic and Muscle-Strengthening Physical Activity: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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>
      This study will be an 8-week randomized controlled trial examining the effects of a&#xD;
      YouTube-delivered aerobic and muscle strengthening physical activity intervention on&#xD;
      university students' physical activity, fitness, sleep quality, and psychosocial health&#xD;
      outcomes. Participants will be randomized into 1 of 2 groups: (1) intervention group (receive&#xD;
      twice-weekly YouTube videos [1 aerobic workout video; 1 muscle-strengthening workout video]&#xD;
      for 8 weeks); or (2) control group (receive twice-weekly YouTube videos with general health&#xD;
      information [no physical activity-related information or workouts] for 8 weeks). Baseline (0&#xD;
      weeks), mid-point (4 weeks), and post-test (8 weeks) testing will take place and the&#xD;
      following outcome measures will be assessed at these time points: participants' free-living&#xD;
      (7-day) objectively-measured physical activity and sleep quality data will be collected;&#xD;
      anthropometric measures (height, weight, percent body fat); cardiorespiratory and muscular&#xD;
      fitness; and psychosocial assessments (perceived physical activity barriers and social&#xD;
      support).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2020</start_date>
  <completion_date type="Actual">April 28, 2021</completion_date>
  <primary_completion_date type="Actual">March 27, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in objectively measured free-living physical activity</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>7-day measurement using wrist-worn ActiGraph tri-axial accelerometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in adherence to muscle-strengthening guidelines</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>Assessed by 7-day physical activity recall interview to see if participants engaged in muscle-strengthening activity at least 2 days per week.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>7-day measurement using wrist-worn ActiGraph tri-axial accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiorespiratory Fitness</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>YMCA 3-minute step test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in muscular fitness</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>60 second pushups and sit-ups muscular endurance tests (maximal repetitions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intrinsic Motivation</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>Psychosocial survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in social support</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>Psychosocial survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceived physical activity barriers</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>Psychosocial survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight (kg)</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>Measured using stadiometer to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height (cm</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured using digital bodyweight scale to the nearest 0.1 cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body fat percentage</measure>
    <time_frame>Baseline, 4 weeks (mid), and 8 weeks (end)</time_frame>
    <description>Measured using the digital weight scale used to assess body weight via bioelectrical impedance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Physical activity intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive twice-weekly, YouTube-delivered aerobic and muscle-strengthening physical activity videos for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General health education control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Will receive twice-weekly, YouTube-delivered videos with general health education information for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>YouTube-delivered aerobic and muscle-strengthening physical activity intervention</intervention_name>
    <description>Participants in the intervention group will receive two YouTube-delivered videos each week, for 8 weeks. In detail, on Monday, participants will receive an aerobic-based physical activity video with information and a workout to complete and on Thursdays, the participants will receive a video with muscle-strengthening physical activity information and a workout to complete.</description>
    <arm_group_label>Physical activity intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-35 years of age; able to participate in aerobic and muscle-strengthening exercise;&#xD;
             healthy (i.e., no diseases or clinical/mental health conditions which will prevent&#xD;
             physical activity participation); does not meet minimum physical activity guidelines&#xD;
             criteria for aerobic (≥ 150 minutes per week of moderate-to-vigorous intensity&#xD;
             physical activity) and muscle-strengthening (≥ 2 days per week; 8-10 exercises for all&#xD;
             major muscle groups) physical activity at time of enrollment; willing to be randomized&#xD;
             to the intervention or control group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years old or greater than 35 years old; physical or mental health&#xD;
             contradictions which do not allow participants to participate in physical activity;&#xD;
             exceed minimum aerobic or muscle-strengthening physical activity guideline&#xD;
             recommendations; unwilling to be randomized to either intervention or control group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel J McDonough, M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota - Twin Cities</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>youtube</keyword>
  <keyword>physical activity</keyword>
  <keyword>fitness</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/NCT04499547
org study id: 2728
nct id: NCT04499547
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be an 8-week randomized controlled trial examining the effects of a
      YouTube-delivered aerobic and muscle strengthening physical activity intervention on
      university students' physical activity, fitness, sleep quality, and psychosocial health
      outcomes. Participants will be randomized into 1 of 2 groups: (1) intervention group (receive
      twice-weekly YouTube videos [1 aerobic workout video; 1 muscle-strengthening workout video]
      for 8 weeks); or (2) control group (receive twice-weekly YouTube videos with general health
      information [no physical activity-related information or workouts] for 8 weeks). Baseline (0
      weeks), mid-point (4 weeks), and post-test (8 weeks) testing will take place and the
      following outcome measures will be assessed at these time points: participants' free-living
      (7-day) objectively-measured physical activity and sleep quality data will be collected;
      anthropometric measures (height, weight, percent body fat); cardiorespiratory and muscular
      fitness; and psychosocial assessments (perceived physical activity barriers and social
      support).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in objectively measured free-living physical activity
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: 7-day measurement using wrist-worn ActiGraph tri-axial accelerometer
measure: Change in adherence to muscle-strengthening guidelines
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: Assessed by 7-day physical activity recall interview to see if participants engaged in muscle-strengthening activity at least 2 days per week.
measure: Change in sleep quality
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: 7-day measurement using wrist-worn ActiGraph tri-axial accelerometer
measure: Change in cardiorespiratory Fitness
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: YMCA 3-minute step test
measure: Change in muscular fitness
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: 60 second pushups and sit-ups muscular endurance tests (maximal repetitions)
measure: Change in intrinsic Motivation
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: Psychosocial survey
measure: Change in social support
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: Psychosocial survey
measure: Change in perceived physical activity barriers
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: Psychosocial survey
measure: Change in body weight (kg)
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: Measured using stadiometer to the nearest 0.1 kg
measure: Height (cm
time frame: Baseline
description: Measured using digital bodyweight scale to the nearest 0.1 cm
measure: Change in body fat percentage
time frame: Baseline, 4 weeks (mid), and 8 weeks (end)
description: Measured using the digital weight scale used to assess body weight via bioelectrical impedance
arm group label: Physical activity intervention
arm group type: Experimental
description: Will receive twice-weekly, YouTube-delivered aerobic and muscle-strengthening physical activity videos for 8 weeks.
arm group label: General health education control
arm group type: No Intervention
description: Will receive twice-weekly, YouTube-delivered videos with general health education information for 8 weeks.
intervention type: Behavioral
intervention name: YouTube-delivered aerobic and muscle-strengthening physical activity intervention
description: Participants in the intervention group will receive two YouTube-delivered videos each week, for 8 weeks. In detail, on Monday, participants will receive an aerobic-based physical activity video with information and a workout to complete and on Thursdays, the participants will receive a video with muscle-strengthening physical activity information and a workout to complete.
arm group label: Physical activity intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel J McDonough, M.S.
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No