<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/NCT04499456</url>
  </required_header>
  <id_info>
    <org_study_id>2017/13831-9</org_study_id>
    <nct_id>NCT04499456</nct_id>
  </id_info>
  <brief_title>Mediators and Moderators of a Web-based Intervention for Alcohol Use</brief_title>
  <official_title>Analysis of Mediators and Moderators of a Web-based Intervention for Alcohol Use Among College Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</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>
      Background: Alcohol use among college students causes health and social problems. However,&#xD;
      even when available, many students do not access alcohol interventions. Web-based&#xD;
      Personalized Normative Feedback (PNF) has been used to disseminate alcohol&#xD;
      brief-interventions, and evidence supports PNF efficacy in reducing alcohol consumption among&#xD;
      this population. On the other hand, studies on PNF mediators and moderators are scarce,&#xD;
      limiting the knowledge on the mechanisms of change and conditions in which their effects&#xD;
      occur. Objective: to evaluate whether normative perceptions mediate, and motivation to&#xD;
      receive the intervention, moderates the effects of a web-based PNF intervention (Pesquisa&#xD;
      Universitária sobre Bebidas - PUB 2.0) for alcohol use among Brazilian college students.&#xD;
      Methods: Pragmatic randomized controlled trial among college students aged 18 and over and&#xD;
      with follow-up assessments after 1, 3 and 6 months. Participants will be randomized into a&#xD;
      Control group (assessment only) or to receive the updated version of the intervention (PUB&#xD;
      2.0). Outcomes are the typical number of drinks (primary outcome) and the total number of&#xD;
      drinks consumed, drinking frequency, maximum number of drinks consumed and number of&#xD;
      consequences (secondary outcomes). Statistical analyses will consider Structural Equation&#xD;
      Models and significance level of 5%. This study will improve knowledge on how and in which&#xD;
      conditions a web-based alcohol PNF effects occur, helping tailor future strategies to reduce&#xD;
      the impact of alcohol problems among college students.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 18, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2022</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Typical alcohol use</measure>
    <time_frame>30 days</time_frame>
    <description>The number of typical drink units consumed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum alcohol use</measure>
    <time_frame>30 days</time_frame>
    <description>The number of maximum drink units consumed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of alcohol use</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of drink units</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of consequences</measure>
    <time_frame>30 days</time_frame>
    <description>The number of consequences</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">685</enrollment>
  <condition>Alcohol Drinking</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Waiting list control receiving the PNF after the last assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single PNF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives PNF after the first assessment only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Boosted PNF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives PNF after every assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalised Normative Feedback</intervention_name>
    <description>The Personalised Normative Feedback provides information on 1) alcohol consumption (the number of drinks consumed, alcohol-pattern use, binge drinking); 2) normative comparisons; 3) alcohol-related consequences; 4) practical costs of alcohol consumption (money spent and calories consumed); 5) strategies to avoid or risks associated with alcohol use.</description>
    <arm_group_label>Boosted PNF</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Single PNF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  College student&#xD;
&#xD;
          -  Alcohol use during the last year&#xD;
&#xD;
          -  Aged 18 or more years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Departamento de Psicobiologia</name>
      <address>
        <city>São Paulo</city>
        <zip>04023062</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>André Bedendo, PhD</last_name>
      <phone>(011) 2149-0155</phone>
      <email>andre.bedendo@unifesp.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>https://www.quantobebo.com.br</url>
    <description>Website delivering by which the intervention is delivered</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 31, 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>December 21, 2021</last_update_submitted>
  <last_update_submitted_qc>December 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>André Bedendo</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04499456
org study id: 2017/13831-9
nct id: NCT04499456
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Alcohol use among college students causes health and social problems. However,
      even when available, many students do not access alcohol interventions. Web-based
      Personalized Normative Feedback (PNF) has been used to disseminate alcohol
      brief-interventions, and evidence supports PNF efficacy in reducing alcohol consumption among
      this population. On the other hand, studies on PNF mediators and moderators are scarce,
      limiting the knowledge on the mechanisms of change and conditions in which their effects
      occur. Objective: to evaluate whether normative perceptions mediate, and motivation to
      receive the intervention, moderates the effects of a web-based PNF intervention (Pesquisa
      Universitária sobre Bebidas - PUB 2.0) for alcohol use among Brazilian college students.
      Methods: Pragmatic randomized controlled trial among college students aged 18 and over and
      with follow-up assessments after 1, 3 and 6 months. Participants will be randomized into a
      Control group (assessment only) or to receive the updated version of the intervention (PUB
      2.0). Outcomes are the typical number of drinks (primary outcome) and the total number of
      drinks consumed, drinking frequency, maximum number of drinks consumed and number of
      consequences (secondary outcomes). Statistical analyses will consider Structural Equation
      Models and significance level of 5%. This study will improve knowledge on how and in which
      conditions a web-based alcohol PNF effects occur, helping tailor future strategies to reduce
      the impact of alcohol problems among college students.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Typical alcohol use
time frame: 30 days
description: The number of typical drink units consumed
measure: Maximum alcohol use
time frame: 30 days
description: The number of maximum drink units consumed
measure: Frequency of alcohol use
time frame: 30 days
measure: Total number of drink units
time frame: 30 days
measure: Number of consequences
time frame: 30 days
description: The number of consequences
arm group label: Control
arm group type: Active Comparator
description: Waiting list control receiving the PNF after the last assessment
arm group label: Single PNF
arm group type: Experimental
description: Receives PNF after the first assessment only
arm group label: Boosted PNF
arm group type: Experimental
description: Receives PNF after every assessment
intervention type: Other
intervention name: Personalised Normative Feedback
description: The Personalised Normative Feedback provides information on 1) alcohol consumption (the number of drinks consumed, alcohol-pattern use, binge drinking); 2) normative comparisons; 3) alcohol-related consequences; 4) practical costs of alcohol consumption (money spent and calories consumed); 5) strategies to avoid or risks associated with alcohol use.
arm group label: Boosted PNF
arm group label: Control
arm group label: Single PNF
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Brazil
url: https://www.quantobebo.com.br
description: Website delivering by which the intervention is delivered
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: André Bedendo
investigator title: Sponsor-Investigator
mesh term: Alcohol Drinking
sharing ipd: Undecided