Clinical trial NCT00792207: The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults
Official title: The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: FitSense/FitLinxx
First posted: 2008-11-17
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in subject weight. Subjects will be weighed at their first study visit and their final visit.
timeFrame: 12 weeks
measure: Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit
timeFrame: 12 weeks
measure: Subject rating on the working alliance inventory score
timeFrame: 12 weeks, assessed at the end of the study
measure: Changes in self-efficacy, quality of or readiness to change (as measured through surveys at the beginning and end of the study).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Partners Health Care Center for Connected Health
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital, Partners Center for Connected Health, Harvard Medical School
name: Alice Watson, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watson A, Bickmore T, Cange A, Kulshreshtha A, Kvedar J. An internet-based virtual coach to promote physical activity adherence in overweight adults: randomized controlled trial. J Med Internet Res. 2012 Jan 26;14(1):e1. doi: 10.2196/jmir.1629.