NCT01340079

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Apr 2011

Typical duration for phase_1 type-2-diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 24, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

March 16, 2011

Last Update Submit

September 20, 2012

Conditions

Type 2 Diabetes

Keywords

diabetes mellitus, non-insulin dependent

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention.

    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.

    Baseline and 8 weeks after completion of the intervention

  • Change from Baseline in physical activity at 8 weeks after completion of the intervention.

    Baseline and 8 weeks after completion of the intervention

Study Arms (2)

Virtual world

EXPERIMENTAL

Virtual world delivery method

Behavioral: virtual world

face to face

ACTIVE COMPARATOR

face to face method of health education

Behavioral: face to face

Interventions

virtual worldBEHAVIORAL

health education using virtual world Second Life

Virtual world
face to faceBEHAVIORAL

health education delivered in face to face groups

face to face

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

    PMID: 25344620DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • John M. Wiecha, MD, MPH

    Boston Medical Center/Boston University Medical Campus

    PRINCIPAL INVESTIGATOR

  • Milagros Rosal, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

April 22, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 24, 2012

Record last verified: 2012-05

Locations

US(1)