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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: virtual world; Behavioral: face to face

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Diagnosed with T2DM
2. HbA1c level >= 8.0
3. 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
4. African-American origin
5. >= 18 years old
6. Telephone in home or easy access to one
7. Able to understand and participate in the study protocol
8. Functionally capable of meeting the activity goals
9. Understands and can provide informed consent
10. Physician approval to participate in the study.

Exclusion Criteria:

1. History of diabetic ketoacidosis
2. Gestational diabetes
3. Unable or unwilling to provide informed consent
4. Plans to move out of the area within the 12-month study period
5. Required intermittent glucocorticoid therapy within the past 3 months
6. Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 months
7. Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease)
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual world; Virtual world delivery method	Behavioral: virtual world; health education using virtual world Second Life
Active Comparator: face to face; face to face method of health education	Behavioral: face to face; health education delivered in face to face groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in hemoglobin a1c at 8 weeks after completion of the intervention.	Baseline and 8 weeks after completion of the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: University of Massachusetts, Worcester
• Investigators: Principal Investigator: John M. Wiecha, MD, MPH, Boston Medical Center/Boston University Medical Campus; Principal Investigator: Milagros Rosal, PhD, University of Massachusetts, Worcester, MA

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: April 20, 2011
• First Posted (Estimate): April 22, 2011

Study Record Updates

• Last Update Posted (Estimate): September 24, 2012
• Last Update Submitted That Met QC Criteria: September 20, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: diabetes mellitus, non-insulin dependent
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 1RC1LM010412-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No