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

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight

Intervention / Treatment
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* Other: Virtual Coach software
* Other: Activity monitor and website


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| Active Comparator: Control<br>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<br>* The control group will use an activity monitor and a website to track activity levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subject weight. Subjects will be weighed at their first study visit and their final visit. |  | 12 weeks | 
| Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit |  | 12 weeks | 
| Subject rating on the working alliance inventory score |  | 12 weeks, assessed at the end of the study | 
| Changes in self-efficacy, quality of or readiness to change (as measured through surveys at the beginning and end of the study). |  | 12 weeks |