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

Sponsors and Collaborators:	Massachusetts General Hospital Northeastern University FitSense/FitLinxx
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00792207

Purpose

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	Intervention
Overweight	Other: Virtual Coach software Other: Activity monitor and website

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults

Further study details as provided by Massachusetts General Hospital:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in subject weight. Subjects will be weighed at their first study visit and their final visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Subject rating on the working alliance inventory score [ Time Frame: 12 weeks, assessed at the end of the study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	June 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention: Experimental 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.
Control: Active Comparator 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.

Eligibility

Ages Eligible for Study:	20 Years to 55 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Responsible Party:	Center for Connected Health ( Alice Watson, MBChB,MRCP,MPH, Corporate Manager - Research and Program Evaluation )
Study ID Numbers:	2007-P-001317/2;MGH
Study First Received:	November 13, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00792207
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Overweight

ClinicalTrials.gov processed this record on January 15, 2009