NCT02726425

Brief Summary

This study evaluates the comparative effectiveness of a diabetes self management (DSM) group medical visit in the virtual world (Second life) verses a face-to-face format, aimed to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
309

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable diabetes-mellitus

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

Study Start

First participant enrolled

July 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

4.8 years

First QC Date

March 28, 2016

Last Update Submit

September 3, 2020

Conditions

Diabetes Mellitus

Keywords

Diabetes self managementSecond Life platformMedical group visits

Outcome Measures

Primary Outcomes (2)

  • Change in physical activity level

    Participants will wear an activity monitor for a week at each collection point. Results measured in METs/hr.

    Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

  • Change in disease control (HbA1c)

    Change in HbA1c from BMC laboratory blood testing results

    Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

Secondary Outcomes (10)

  • Patient Activation

    Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

  • Medication Adherence

    Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

  • Depression

    Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

  • Improvement in cholesterol, hypertension and body weight

    Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

  • Health-Related Quality of Life

    Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up

  • +5 more secondary outcomes

Study Arms (2)

Second Life Participants

EXPERIMENTAL

Half of participants will receive the Diabetes Self Management Medical Group Visits intervention while meeting in the virtual world (Second Life platform)

Behavioral: Diabetes Self Management Medical Group Visits

Face-to-Face Participants

ACTIVE COMPARATOR

The other half of the participants will receive the Diabetes Self Management Medical Group Visitsintervention while meeting face-to-face in person at Boston Medical Center.

Behavioral: Diabetes Self Management Medical Group Visits

Interventions

Diabetes Self Management Medical Group VisitsBEHAVIORAL

The Women in Control DSM intervention involves: (1) 8-wk series of interactive, educational medical group visit sessions with groups of 10-12 participants, led by clinicians \& peer leaders lasting \~100'' in length conducted either in Spanish or English and (2) Individual consultation with a clinician lasting 10-15 minutes. Group visits will consist of experiential and discussion based learning of topics including the importance of diet, physical activity, medications, mindfulness and stress reduction to diabetes self management.

Face-to-Face ParticipantsSecond Life Participants

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with type 2 diabetes mellitus (documented in the medical chart)
  • Last recorded HbA1c \>8.0
  • Currently treated with diet, oral hypoglycemic agents or insulin
  • Black/African American or Hispanic/Latina origin
  • Has telephone access
  • Able to understand and participate in study protocol
  • Functionally capable of meeting the activity goals
  • Understand and give informed consent
  • Physician approval to participate in study
  • Can communicate in English or Spanish

You may not qualify if:

  • History of diabetic ketoacidosis
  • Currently or planning pregnancy
  • Unable or unwilling to provide informed consent
  • Plans to leave area within 6 month study period that would interfere with ability to attend 8 weekly sessions and/or 6 month follow up
  • Required intermittent glucocorticoid therapy within past 3 months.
  • Experienced acute coronary event (myocardial infarction or unsable angina) within previous 6 months
  • Medical condition that precludes adherence to study dietary recommendations (i.e. Crohn's, ulcerative colitis, etc)
  • Medical or serious psychiatric illness (dementia, suicidal within last 5 months, psychiatric hospitalization). Those with diagnosis of depression or who take antidepressents are eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

  • Mitchell SE, Mako M, Sadikova E, Barnes L, Stone A, Rosal MC, Wiecha J. The comparative experiences of women in control: diabetes self-management education in a virtual world. J Diabetes Sci Technol. 2014 Nov;8(6):1185-92. doi: 10.1177/1932296814549829. Epub 2014 Sep 10.

    PMID: 25212580BACKGROUND

  • Mitchell SE, Bragg A, De La Cruz BA, Winter MR, Reichert MJ, Laird LD, Moldovan IA, Parker KN, Martin-Howard J, Gardiner P. Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial. J Med Internet Res. 2023 May 10;25:e43669. doi: 10.2196/43669.

    PMID: 37163341DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Suzanne E Mitchell, MD, MS

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 1, 2016

Study Start

July 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)