NCT00792207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

Enrollment Period

3 months

First QC Date

November 13, 2008

Last Update Submit

December 2, 2009

Conditions

Overweight

Outcome Measures

Primary Outcomes (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.

    12 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

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

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

Interventions

Virtual Coach softwareOTHER

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.

Intervention
Activity monitor and websiteOTHER

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

Control

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Disability, medical or surgical condition preventing or precluding moderate physical activity.
  • Cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Partners Health Care Center for Connected Health

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 22281837DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Alice Watson, MD,MPH

    Massachusetts General Hospital, Partners Center for Connected Health, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 17, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 4, 2009

Record last verified: 2009-12

Locations

US(1)