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Engaging Women With the Gabby System to Deliver Multiple Health-Related Behavioral Changes: A Feasibility Study

A Randomized Controlled Trial of A Virtual Patient Advocate System: Go to Gabby for Health and Wellness Information

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02965651
Enrollment
61
Registered
2016-11-17
Start date
2015-01-31
Completion date
2016-01-31
Last updated
2017-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Emotional

Keywords

embodied conversational agent, virtual patient agent, meditation, mindfulness based stress reduction, nutrition

Brief 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.

Interventions

BEHAVIORALECA System

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.

Sponsors

Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* English fluency sufficient to follow treatment instructions and answer survey questions * Access to a telephone (landline, cellular phone) * Access to a computer/laptop with internet/Wi-Fi access

Exclusion criteria

* Known or planned pregnancy * Mental health or substance abuse problems that would bar completion of study * Refusal of consent

Design outcomes

Primary

MeasureTime frameDescription
Number of people recruited1 year
Number of participants who completed the study1 month
Number of participants whom outcome data can be collected1 month
Number of participants who were racial minorities (non-white)1 month
Participant satisfaction with either treatment arm1 monthLikert scale of 1-7 (1=not satisfied, 7=very satisfied)

Secondary

MeasureTime frameDescription
Age1 month
Race1 month
Ethnicity1 month
Education Level1 month
Work Status1 month
Income Level1 month
BMI1 monthHeight (ft) and weight (lbs)
Food Access1 monthHousehold Food Insecurity Access Scale
Medication Use1 monthSelf-reported; cross-checked with medical records
Smoking Status1 month
Pain Levels1 monthPain scale of 0-10 (0=no pain, 10=worst possible pain)
Depression1 monthPatient Health Questionnaire - 9 items
Stress Level1 monthPerceived Stress Scale - 4 items
Dietary Patterns1 monthNutrition Survey
Health Conditions1 monthSelf-reported; cross-checked with medical records
Physical Activity1 monthStanford Patient Education Research Center Exercise Behaviors
Number of Logins into the ECA1 monthIntervention users only
Duration of ECA Use1 monthIntervention users only (minutes)
Technical issues1 monthIntervention users only

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026