Type 2 DiabetesPhase 1/2NCT01340079
Virtual World Health Behavior Counseling for Patients With Diabetes
A Phase 1/2 study testing virtual world and face to face in people with Type 2 Diabetes, run by Boston Medical Center at 1 site in United States.
Trial summary
Comparison of 2 methods of delivery health education for African-American women with Type 2 Diabetes. The two methods are: face to face education in small groups, as compared to delivering the same curriculum in the virtual world, Second Life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- virtual world and face to face
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2012
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with T2DM
- HbA1c level >= 8.0
- Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents
- African-American origin
- >= 18 years old
- Telephone in home or easy access to one
Show all 10Show fewer
- Able to understand and participate in the study protocol
- Functionally capable of meeting the activity goals
- Understands and can provide informed consent
- Physician approval to participate in the study.
Who cannot join
- History of diabetic ketoacidosis
- Gestational diabetes
- Unable or unwilling to provide informed consent
- Plans to move out of the area within the 12-month study period
- Required intermittent glucocorticoid therapy within the past 3 months
- Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 months
- Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease)
- Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an neuroleptic medication). We will not exclude based on history of depression or anxiety or taking anti-depressants or anti-anxiety medications.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of 2 methods of delivery health education for African-American women with Type 2 Diabetes. The two methods are: face to face education in small groups, as compared to delivering the same curriculum in the virtual world, Second Life.
Read the detailed description
This study will provide health education to African-American women with type 2 diabetes either face to face, or using the Internet. The study seeks to determine how feasible the internet method is for this type of health education, and how it compares to the face to face method. Patients will be recruited from Boston Medical Center. They will do baseline surveys and have blood drawn. They will then be randomized into receiving their diabetes education in a face to face group at BMC, or receiving it online while at home. The online group will receive a computer to access the Internet program and Internet access. Both groups will participate in 8 diabetes education groups, and 4 individual counseling sessions. Subjects will complete surveys before and after the study to measure changes in physical activity, diet, and use of medications, and will have blood tests drawn at BMC before and after the study to measure changes in diabetes control, cholesterol. They will also have blood pressure measured before and after the study period.
- Conditions
- Type 2 Diabetes
- Being tested
- virtual world, face to face
- Keywords
- diabetes mellitus, non-insulin dependent
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual worldBehavioural
health education using virtual world Second Life
face to faceBehavioural
health education delivered in face to face groups
| Study group | Role | What they receive |
|---|---|---|
| Virtual world | Experimental | Virtual world delivery method Receives: Behavioral: virtual world |
| face to face | Active comparator | face to face method of health education Receives: Behavioral: face to face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention.
Measured: Baseline and 8 weeks after completion of the intervention
Secondary outcomes (2)
Change from Baseline in dietary patterns at 8 weeks after completion of the intervention.
Measured: Baseline and 8 weeks after completion of the intervention
Change from Baseline in physical activity at 8 weeks after completion of the intervention.
Measured: Baseline and 8 weeks after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionJul 2012
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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- John M. Wiecha, MD, MPH, Principal investigator, Boston Medical Center/Boston University Medical CampusMilagros Rosal, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340079
- Sponsor's protocol ID
- 1RC1LM010412-01
- Status last verified
- May 2012
- First submitted
- 16 Mar 2011
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosal MC, Heyden R, Mejilla R, Capelson R, Chalmers KA, Rizzo DePaoli M, Veerappa C, Wiecha JM. A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial. JMIR Res Protoc. 2014 Oct 24;3(4):e54. doi: 10.2196/resprot.3412.
PubMed 25344620
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual World Health Behavior Counseling for Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01340079
- Acronym / sponsor ID
- 1RC1LM010412-01
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes mellitus, non-insulin dependent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Apr 2011 (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.
Comparison of 2 methods of delivery health education for African-American women with Type 2 Diabetes. The two methods are: face to face education in small groups, as compared to delivering the same curriculum in the virtual world, Second Life.
Detailed description
This study will provide health education to African-American women with type 2 diabetes either face to face, or using the Internet. The study seeks to determine how feasible the internet method is for this type of health education, and how it compares to the face to face method. Patients will be recruited from Boston Medical Center. They will do baseline surveys and have blood drawn. They will then be randomized into receiving their diabetes education in a face to face group at BMC, or receiving it online while at home. The online group will receive a computer to access the Internet program and Internet access. Both groups will participate in 8 diabetes education groups, and 4 individual counseling sessions. Subjects will complete surveys before and after the study to measure changes in physical activity, diet, and use of medications, and will have blood tests drawn at BMC before and after the study to measure changes in diabetes control, cholesterol. They will also have blood pressure measured before and after the study period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual world | Experimental | Behavioral: virtual worldVirtual world delivery method |
| face to face | Active comparator | Behavioral: face to faceface to face method of health education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with T2DM
- HbA1c level >= 8.0
- Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents
- African-American origin
- >= 18 years old
Key exclusion criteria (8 listed)
- History of diabetic ketoacidosis
- Gestational diabetes
- Unable or unwilling to provide informed consent
- Plans to move out of the area within the 12-month study period
- Required intermittent glucocorticoid therapy within the past 3 months
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 worldhealth education using virtual world Second Life | Behavioural | Virtual world |
| face to facehealth education delivered in face to face groups | Behavioural | face to face |
Primary outcome
Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention.
Time frame: Baseline and 8 weeks after completion of the intervention
2 secondary outcomes
Change from Baseline in dietary patterns at 8 weeks after completion of the intervention.
Time frame: Baseline and 8 weeks after completion of the intervention
Change from Baseline in physical activity at 8 weeks after completion of the intervention.
Time frame: Baseline and 8 weeks after completion of the intervention
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 24 Sep 2012.
- Derived from this study: PubMed 25344620Rosal MC, Heyden R, Mejilla R, Capelson R, Chalmers KA, Rizzo DePaoli M, Veerappa C, Wiecha JM. A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial. JMIR Res Protoc. 2014 Oct 24;3(4):e54. doi: 10.2196/resprot.3412.
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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.
John M. Wiecha, MD, MPH principal investigator
Boston Medical Center/Boston University Medical Campus
Milagros Rosal, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing virtual world and face to face in people with Type 2 Diabetes, run by Boston Medical Center 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 10 inclusion and 8 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 24 Sep 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention. (time frame: Baseline and 8 weeks after completion of the intervention). 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 NCT01340079, 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 24 Sep 2012.