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

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ClinicalTrials.gov Identifier: NCT00792207
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : December 4, 2009
Sponsor:
Collaborators:
Northeastern University
FitSense/FitLinxx
Information provided by:
Massachusetts General Hospital

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
Overweight Other: Virtual Coach software Other: Activity monitor and website Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : June 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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.




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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in subject weight. Subjects will be weighed at their first study visit and their final visit. [ Time Frame: 12 weeks ]
  2. Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit [ Time Frame: 12 weeks ]
  3. Subject rating on the working alliance inventory score [ Time Frame: 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). [ Time Frame: 12 weeks ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792207


Locations
United States, Massachusetts
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alice Watson, MBChB,MRCP,MPH, Corporate Manager - Research and Program Evaluation, Center for Connected Health
ClinicalTrials.gov Identifier: NCT00792207     History of Changes
Other Study ID Numbers: 2007-P-001317/2;MGH
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: December 4, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms