OverweightStepUpNCT00792207
The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults
A study testing Virtual Coach software and Activity monitor and website in people with Overweight, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Virtual Coach software and Activity monitor and website
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Disability, medical or surgical condition preventing or precluding moderate physical activity.
- Cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Partners Health Care Center for Connected Health
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Overweight
- Being tested
- Virtual Coach software, Activity monitor and website
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Activity monitor and websiteOther
The control group will use an activity monitor and a website to track activity levels.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Activity monitor and website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
Change in subject weight. Subjects will be weighed at their first study visit and their final visit.
Measured: 12 weeks
Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit
Measured: 12 weeks
Subject rating on the working alliance inventory score
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, FitSense/FitLinxx
- Investigators
- Alice Watson, MD,MPH, Principal investigator, Massachusetts General Hospital, Partners Center for Connected Health, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792207
- Sponsor's protocol ID
- 2007-P-001317/2;MGH
- Acronym
- StepUp
- Status last verified
- Dec 2009
- First submitted
- 13 Nov 2008
- Last updated
- 4 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22281837
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults
- ClinicalTrials.gov ID
- NCT00792207
- Acronym / sponsor ID
- StepUp / 2007-P-001317/2;MGH
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Northeastern University, FitSense/FitLinxx
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Virtual Coach softwareIntervention 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. |
| Control | Active comparator | Other: Activity monitor and websiteThe 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Disability, medical or surgical condition preventing or precluding moderate physical activity.
- Cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Coach softwareThe 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. | Other | Intervention |
| Activity monitor and websiteThe control group will use an activity monitor and a website to track activity levels. | Other | Control |
Primary outcome
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
4 secondary outcomes
Change in subject weight. Subjects will be weighed at their first study visit and their final visit.
Time frame: 12 weeks
Change in subject waist circumference. Subjects will be measured at their first study visit and their final visit
Time frame: 12 weeks
Subject rating on the working alliance inventory score
Time frame: 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).
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
- Derived from this study: PubMed 22281837Watson 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.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Watson, MD,MPH principal investigator
Massachusetts General Hospital, Partners Center for Connected Health, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Coach software and Activity monitor and website in people with Overweight, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2009.