NCT02928952

Brief Summary

The purpose of this study is to see if adding Mindfulness training to diabetes education reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve diabetes outcomes (such as hemoglobin A1c).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2016

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

First Submitted

Initial submission to the registry

October 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 28, 2021

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

3.4 years

First QC Date

October 4, 2016

Results QC Date

March 10, 2021

Last Update Submit

May 27, 2021

Conditions

Diabetes Mellitus

Keywords

MindfulnessDiabetes Distress

Outcome Measures

Primary Outcomes (1)

  • Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress)

    A 20-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores are summed and multiplied by 1.25. Minimum value = 0; Maximum value = 100. Higher scores denote higher levels of diabetes related distress. The cutoff for significant distress is 33; a score of 40 is consistent with diabetes burn-out.

    baseline, 12 weeks and 24 weeks

Secondary Outcomes (15)

  • Diabetes Self-efficacy Scale (DSES)

    baseline, 12 weeks and 24 weeks

  • Hemoglobin A1c (A1C)

    baseline, 12 weeks and 24 weeks

  • Mindfulness Attention and Awareness Scale (MAAS)

    baseline, 12 weeks and 24 weeks

  • Body Weight

    baseline, 12 weeks and 24 weeks

  • Blood Pressure

    baseline, 12 weeks and 24 weeks

  • +10 more secondary outcomes

Other Outcomes (2)

  • Change in 6-item PROMIS Short Form v1.0 Pain Interference 6 b

    baseline, 12 weeks and 24 weeks

  • Insomnia Severity Index (ISI)

    baseline, 12 weeks and 24 weeks

Study Arms (2)

Diabetes Self Management Education (DSME) + Mind-STRIDE

EXPERIMENTAL

Will receive routine diabetes self-management education + the Mind-STRIDE intervention

Behavioral: Mind-STRIDE

DSME alone

NO INTERVENTION

Usual care control

Interventions

Mind-STRIDEBEHAVIORAL

Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education

Diabetes Self Management Education (DSME) + Mind-STRIDE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referral to DSME class at VA Pittsburgh Healthcare System University Drive Campus (VAPHS UD)
  • Diagnosis of type 1 or type 2 diabetes
  • Hemoglobin A1C \>7.0%
  • Problem Areas in "Diabetes Scale (PAID) -5" score =/ \>3 or "Diabetes Distress Scale -2" =/\>2 score indicating the presence of Diabetes-related Distress

You may not qualify if:

  • Documented cognitive impairment that would interfere with the ability to comprehend the informed consent and actively participate in the study
  • Previous attendance of VA DSME class within the past 12 months
  • Currently active mindfulness practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • DiNardo MM, Greco C, Phares AD, Beyer NM, Youk AO, Obrosky DS, Morone NE, Owen JE, Saba SK, Suss SJ, Siminerio L. Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002631. doi: 10.1136/bmjdrc-2021-002631.

    PMID: 35346971DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Monica DiNardo PhD, Primary Investigator
Organization
VAPHS, Center for Heath Equity Research and Promotion
monica.dinardo@va.gov
412 360-2262

Study Officials

  • Monica M. DiNardo, PhD ARNP CDE

    VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 10, 2016

Study Start

November 1, 2016

Primary Completion

April 9, 2020

Study Completion

April 9, 2020

Last Updated

May 28, 2021

Results First Posted

May 28, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

There are currently no plans to share Individual Participant Data (IPD).

Locations

US(1)