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

Overweight Clinical Trial

— StepUp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792207
• Other study ID #: 2007-P-001317/2;MGH
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: December 2, 2009
• Start date: June 2008
• Est. completion date: September 2008

Study information

• Verified date: December 2009
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

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.
• Activity monitor and website
The control group will use an activity monitor and a website to track activity levels.

Locations

Country	Name	City	State
United States	Partners Health Care Center for Connected Health	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	FitSense/FitLinxx, Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in subject weight. Subjects will be weighed at their first study visit and their final visit.		12 weeks	No
Secondary	Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit		12 weeks	No
Secondary	Subject rating on the working alliance inventory score		12 weeks, assessed at the end of the study	No
Secondary	Changes in self-efficacy, quality of or readiness to change (as measured through surveys at the beginning and end of the study).		12 weeks	No