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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00792207
Collaborator
Northeastern University (Other), FitSense/FitLinxx (Other)
70
1
2
3
23.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Coach software
  • Other: Activity monitor and website
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Change in subject weight. Subjects will be weighed at their first study visit and their final visit. [12 weeks]

  2. Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit [12 weeks]

  3. Subject rating on the working alliance inventory score [12 weeks, assessed at the end of the study]

  4. Changes in self-efficacy, quality of or readiness to change (as measured through surveys at the beginning and end of the study). [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Partners Health Care Center for Connected Health Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Northeastern University
  • FitSense/FitLinxx

Investigators

  • Principal Investigator: Alice Watson, MD,MPH, Massachusetts General Hospital, Partners Center for Connected Health, Harvard Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00792207
Other Study ID Numbers:
  • 2007-P-001317/2;MGH
First Posted:
Nov 17, 2008
Last Update Posted:
Dec 4, 2009
Last Verified:
Dec 1, 2009
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2009