Engaging Women With the Gabby System to Deliver Multiple Health-Related Behavioral Changes: A Feasibility Study
Condition: Stress, Emotional
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial is to evaluate the feasibility of introducing
      an innovative eHealth technology, the Embodied Conversational Agent (ECA), to diverse women
      from an urban outpatient setting.
    

Detailed description: 
      This trial focuses on using an embodied conversational agent (ECA) named Gabby to teach
      healthy lifestyle behaviors (healthy eating, exercise, stress reduction). This feasibility
      randomized control trial will include 70 women in the outpatient setting (35 intervention and
      35 controls). The control group will receive usual care (patient information sheets on
      healthy eating, exercise, stress reduction and a CD with meditation, body scan, and mindful
      yoga).

      The ECA is an animated conversational character who simulates face-to-face interaction with a
      patient. During the intervention, the ECA talks using synthetic speech and synchronized
      animation; patients "talk" by clicking what they want to say using a computer's mouse. The
      ECA delivers information and experiential on stress (principles of mindfulness based stress
      reduction such as: meditation, yoga, body scan), nutrition, and exercise.

      If participants are randomized to the intervention, a research assistant (RA) will teach the
      subject how to use the ECA workstation. The ECA will review with the patients their
      nutrition, stress, exercise, using the ECA workstation which will also be programmed with the
      subject's baseline information (e.g., name, age). Subjects will be asked to log onto the
      system once a day and interact with the system for as long as they wish.

      Prior to the midpoint survey, participants will receive a reminder phone call/email. At 14
      days, the RA will survey all participants regarding satisfaction with either the ECA or the
      paper handouts, and whether or not they are adhering to the lifestyle modification
      recommendations. This will be conducted either by email, phone or in person.

      Prior to the end of the 30 day study participation, the RA will call or email to schedule a
      visit to complete the post intervention questionnaire. The RA will call/email 1-2 days before
      the final study visit to remind the participant.

      The RA will conduct the post intervention interview in person or by phone. All participants
      received compensation for completion of surveys.

      Control Group: The control subjects will receive usual care (patient information sheets on
      stress, nutrition and exercise and a CD). The RA will administer the same baseline, mid-point
      and final surveys to the control participants.

      The investigators do not know, however, whether health information technology can be used
      effectively to deliver information on exercise, nutrition and stress in the outpatient
      setting. This study will add new information to the viability of using the ECA in women in
      the outpatient setting compared to patient information sheets.
    

Intervention name(s): ECA System
Intervention type(s): Behavioral
Intervention description(s): The ECA system, named "Gabby", included content pertaining to stress management, nutrition and physical activity as well as dialogue scripts and media such as meditations. The scripts included motivational interviewing dialogue: dialogue to simulate shared decision making interactions and additional longitudinal interaction using techniques such as "goal setting," "problem solving," "tips," and "homework". Gabby was available on a web browser through a username and secure password login.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: embodied conversational agent; virtual patient agent; meditation; mindfulness based stress reduction; nutrition