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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Coach software
Activity monitor and website
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Partners Health Care Center for Connected Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 13, 2008
Last Updated
December 2, 2009
Sponsor
Massachusetts General Hospital
Collaborators
Northeastern University, FitSense/FitLinxx
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1. Study Identification

Unique Protocol Identification Number
NCT00792207
Brief Title
The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults
Acronym
StepUp
Official Title
The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
Northeastern University, FitSense/FitLinxx

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Coach software
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Activity monitor and website
Intervention Description
The control group will use an activity monitor and a website to track activity levels.
Primary Outcome Measure Information:
Title
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in subject weight. Subjects will be weighed at their first study visit and their final visit.
Time Frame
12 weeks
Title
Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit
Time Frame
12 weeks
Title
Subject rating on the working alliance inventory score
Time Frame
12 weeks, assessed at the end of the study
Title
Changes in self-efficacy, quality of or readiness to change (as measured through surveys at the beginning and end of the study).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Watson, MD,MPH
Organizational Affiliation
Massachusetts General Hospital, Partners Center for Connected Health, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Partners Health Care Center for Connected Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22281837
Citation
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.
Results Reference
derived

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

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