## Protocol Section
### Identification Module
**NCT ID:** NCT01340079

**Brief Title:** Virtual World Health Behavior Counseling for Patients With Diabetes

**Official Title:** Virtual World Health Behavior Counseling for Patients With Diabetes

#### Organization Study ID Info
**ID:** 1RC1LM010412-01
**Link:** https://reporter.nih.gov/quickSearch/1RC1LM010412-01
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Boston Medical Center
### Status Module
#### Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-09-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-09-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Start Date
**Date:** 2011-04

**Status Verified Date:** 2012-05

#### Study First Post Date
**Date:** 2011-04-22
**Type:** ESTIMATED
**Study First Submit Date:** 2011-03-16
**Study First Submit QC Date:** 2011-04-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Massachusetts, Worcester

#### Lead Sponsor

**Class:** OTHER

**Name:** Boston Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Type 2 Diabetes

**Keywords:**

- diabetes mellitus, non-insulin dependent

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 89

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Virtual world delivery method

**Intervention Names:**

- Behavioral: virtual world

**Label:** Virtual world

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** face to face method of health education

**Intervention Names:**

- Behavioral: face to face

**Label:** face to face

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Virtual world

**Description:** health education using virtual world Second Life

**Name:** virtual world

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- face to face

**Description:** health education delivered in face to face groups

**Name:** face to face

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**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

#### Secondary Outcomes

**Measure:** 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

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Boston Medical Center

**State:** Massachusetts

**Zip:** 02118

#### Overall Officials

**Official 1:**

**Affiliation:** Boston Medical Center/Boston University Medical Campus

**Name:** John M. Wiecha, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Massachusetts, Worcester, MA

**Name:** Milagros Rosal, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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:** 25344620

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-24
