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Completed

NCT Number: NCT01340079

Virtual World Health Behavior Counseling for Patients With Diabetes

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

virtual world

Behavioral

health education using virtual world Second Life

Face to Face

Behavioral

health education delivered in face to face groups

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • University of Massachusetts, Worcester

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 22, 2011
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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