Balanced Lifestyle for Undergraduate Excellence - Mobile (Project BLUEM)
Condition: Binge Drinking; Alcohol Drinking in College; Behavior, Drinking; Behavior and Behavior Mechanisms
MeSH terms: Binge Drinking; Alcohol Drinking; Alcohol Drinking in College; Drinking Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a text-message delivered approach for improving
      college adjustment and experience and reducing risky alcohol use in young adult college
      students. The study compares a text-message delivered brief motivational intervention for
      reducing alcohol use and increasing engagement in alcohol-free activities, to text-message
      delivered alcohol and nutrition education sessions. The investigators predict that
      individuals who receive the brief motivational intervention will report less alcohol use and
      fewer related problems 3 months following the intervention compared to those who receive the
      education sessions. The investigators also expect that these individuals will report greater
      engagement in alcohol-free activities compared to those who receive the education sessions.
    

Detailed description: 
      The proposed project will develop and empirically evaluate a mobile-based alcohol brief
      intervention and substance-free activity session. To do this, study personnel will develop
      and systematically evaluate an intervention that includes efficacious elements of brief
      alcohol interventions along with personalized feedback. Intervention elements will be
      delivered remotely via personalized web-based feedback and text-messages. The proposed
      project will evaluate the efficacy of the mobile-based brief alcohol intervention compared to
      mobile-based alcohol and nutrition education in the context of a randomized pilot trial.

      This research will be divided into two stages: Stage 1, the screening stage, and Stage 2, the
      randomized pilot trial stage. During the screening stage, participants will be recruited and
      screened for eligibility to participate in Stage 2. The randomized controlled trial stage
      (stage 2) will test the feasibility and efficacy of a mobile-based BMI + SFAS in the context
      of a two-group experimental design. All students (N = 100) will complete a baseline
      assessment and will then be randomly assigned to either receive a mobile-based BMI + SFAS, or
      mobile-based alcohol and nutrition education. Each group will receive 4 weeks of booster
      contact (1 booster session per week) on material from their respective study condition.
      Outcomes will be assessed after the fourth booster session and at a 3-month follow-up.

      Participants will complete a brief screening survey via the SONA system or through a secure
      web-link sent via email or posted in flyers to identify those students who might be eligible
      to participate in the study. In order to be contacted about the clinical trial, respondents
      will be asked to provide contact information. Ads and flyers will also include study contact
      information for interested respondents/participants to contact study staff directly and
      screen for eligibility.

      If the participant meets eligibility criteria, the researcher will speak with the participant
      via phone call to explain the project procedures and confidentiality in more detail, and
      allow the participant the opportunity to ask any questions they may have about the study.
      Text messaging and email may also be used as methods to communicate with participants who
      meet the eligibility criteria and will be used as the primary method of communication if the
      student prefers. Participants will be informed that the study is designed to learn more about
      college students' lifestyle and health behaviors and that the study will involve random
      assignment to one of two treatment conditions, along with 4 booster sessions by text-message,
      a post-intervention survey immediately following the 4th booster session, and a survey
      follow-up three months after their last booster session. If the participant expresses
      interest in the study, the study administrator will invite them to participate in further
      phases of the study. If students do not meet the eligibility criteria at the time of
      screening, but indicate drinking in the past 6-months, they may be contacted later and
      re-screened via phone, text message or email and then enrolled if interested in the study.
      Eligible and interested individuals will remotely read and e-sign the consent form, provide
      contact information, and complete the initial baseline assessment via a secure web-link.

      All self-report measures will be completed by the participant via a secure, web-based survey.
      Prior to completing baseline measures, participants will be provided with a consent form and
      will be informed of the study's purpose, risks, benefits, compensation, and all other
      pertinent study details. Participants will be provided with a phone number and email address
      should they have questions and will also be informed in the consent that they can discontinue
      the study at any time. If participants choose not to e-sign the consent form or decide not to
      participate in the study at any time, they will be provided with information about college
      student alcohol misuse on websites, hotlines, and local resources to learn more about their
      drinking if they are interested. The remote web-based assessment will last approximately 30
      minutes. After completing the assessment, participants will be randomized to either a) the
      mobile-based BMI+SFAS (mBMI+SFAS); or b) mobile-based alcohol and nutrition education (mA+NE)
      (both described below). Immediately following the baseline assessment and random assignment,
      participants will take part in a 60-minute session of either the mobile BMI or mobile Alcohol
      Education. Later the same week, participants will take part in either one 60-minute session
      of the mobile SFAS or mobile Nutrition Education. The interventionist conducting the mobile
      BMI or Alcohol Education earlier in the week will also conduct the mobile SFAS or Nutrition
      Education, respectively, as well as all booster contact. A brief 3-item survey will be
      administered immediately following the mobile SFAS or Nutrition Education session that will
      solicit initial impressions and feedback on these respective sessions.

      Booster contact will take place once a week for four weeks for approximately 20 minutes.
      Booster contact for the mBMI+SFAS group will also collect information on past week time
      allocation, level of discounting of future monetary rewards (delay discounting), and the
      subjective reward value of alcohol, which are associated with problematic alcohol use. Upon
      completion of the booster contact, participants will complete a 5-week assessment survey via
      secure web link. The post-intervention survey will collect information on the participants'
      experiences with the mobile-based interventions and will solicit feedback about the
      interventions. They will then be thanked for their participation and reminded of their
      3-month follow-up appointment.

      All participants will be asked to download on to their smartphone or personal computer a
      secure messaging web app called Babelnet (https://www.babelnet.com/en/). Babelnet is free to
      download and use, and study personnel will assist participants in the download and use of the
      app. Participants will be assigned a username that will be similar to their study
      identification number and a password that will be saved in a secure, password protected file
      only accessible to study personnel. In the event a participant has forgotten or lost their
      Babelnet login information, they may contact study personnel to retrieve it and log in
      securely. Messages sent through Babelnet are heavily encrypted by the app. However, study
      personnel will record (via screenshot or copy-and-paste) the text conversations to facilitate
      later communication and for intervention supervisory, as well as fidelity, purposes. These
      recordings will be saved on a secure server in a password protected shared drive that is
      accessible only to study personnel.

      Three months post-booster completion, participants will be asked to remotely complete a
      web-based follow-up self-report assessment battery. The follow-up will assess the impact of
      the interventions on attitudes and behaviors toward alcohol use, as well as patterns of
      alcohol-related problems and drinking levels, and will last approximately 30 minutes.

      After the 3-month assessment, participants will be given the option to complete any of the
      intervention sessions that they did not complete as a part of the study or to complete a
      session for a second time.
    

Intervention name(s): Brief Motivational Intervention+Substance-Free Activity Session; Alcohol + Nutrition Education Session
Intervention type(s): Behavioral; Other
Intervention description(s): A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.; Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.
Other intervention name(s): BMI+SFAS; mBMI+SFAS; mobile BMI+SFAS; A+NE; mA+NE; mobile A+NE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention