The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults (StepUp)

Hypothesis: Overweight subjects using a Virtual Coach will demonstrate improved adherence to an exercise regime.

This study is designed to examine the effect of a computer program called a "Virtual Coach" and find out if it helps people become more active. This program acts as a kind of a personal trainer and will give you feedback. All participants in the study will receive an activity monitor to wear during the study and a website to use to track activity. Half of the participants will also receive the virtual coach software. This software will have to be downloaded onto your computer, and we will ask that you check in with the coach using the software three times a week for 12 weeks. The group you will be placed in will be selected by chance.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Other: Virtual Coach software; Other: Activity monitor and website

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Partners Health Care Center for Connected Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults age 20-55 inclusive
• BMI between 25 and 35 inclusive (overweight and Class 1 obese subjects)
• PC Computer with an available USB port, speakers and high-speed internet access in a secure setting (home or private office)
• Fluency in English (spoken and written)
• Have a Primary Care Physician
• Answer "No" to all 7 questions on PAR-Q OR have letter from PCP clearing them to take part in study

Exclusion Criteria:

• Disability, medical or surgical condition preventing or precluding moderate physical activity.
• Cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intervention Group: The intervention being tested, the Virtual Coach, is an automated empathic computer agent which will run on patient's home computer and engage the patient in dialogues to deliver personalized feedback, education and coaching based on physiological data recorded by an activity monitor.	Other: Virtual Coach software; The intervention being tested, the Virtual Coach, is an automated empathic computer agent which will run on patient's home computer and engage the patient in dialogues to deliver personalized feedback, education and coaching based on physiological data.
Active Comparator: Control; The control group will use an activity monitor and will have access to a website to monitor activity, but will not receive the Virtual Coach program.	Other: Activity monitor and website; The control group will use an activity monitor and a website to track activity levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome being measured is the level of activity monitored by the activity monitor. Control and Intervention subjects will be encouraged to wear the activity monitor on a daily basis for the 12 week course of the study.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in subject weight. Subjects will be weighed at their first study visit and their final visit.	12 weeks
Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit	12 weeks
Subject rating on the working alliance inventory score	12 weeks, assessed at the end of the study
Changes in self-efficacy, quality of or readiness to change (as measured through surveys at the beginning and end of the study).	12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Northeastern University; FitSense/FitLinxx
• Investigators: Principal Investigator: Alice Watson, MD,MPH, Massachusetts General Hospital, Partners Center for Connected Health, Harvard Medical School

Publications and helpful links

General Publications

• Watson A, Bickmore T, Cange A, Kulshreshtha A, Kvedar J. An internet-based virtual coach to promote physical activity adherence in overweight adults: randomized controlled trial. J Med Internet Res. 2012 Jan 26;14(1):e1. doi: 10.2196/jmir.1629.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 14, 2008
• First Posted (Estimate): November 17, 2008

Study Record Updates

• Last Update Posted (Estimate): December 4, 2009
• Last Update Submitted That Met QC Criteria: December 2, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 2007-P-001317/2;MGH