Decreasing Stress in Diabetes

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT04016415
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness Based Stress Reduction — BEHAVIORAL
    Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations.
  • Stress Management Education — BEHAVIORAL
    Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc.

Study Details

The purpose of this study is to conduct a randomized controlled trial (RCT) to determine the effects of an online 6-month Mindfulness-based stress reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose control in adults with uncontrolled type 1 or type 2 diabetes. The study will randomize at least 290 adults with uncontrolled diabetes to a 6-month MBSR intervention or SME control. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. Outcomes will be assessed at baseline, a follow-up phone call after Class #4, and study visits at 2-months (2MO) and 6-months (6MO).

Key Dates

Start date
Jul 28, 2020
Status verified
Sep 2025
Primary completion
Aug 9, 2024
Completion
Aug 9, 2024

Study Design

Enrollment
309 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness Based Stress Reduction
  • Active Comparator: Stress Management Education

Primary Outcome Measure

Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) [ Time Frame: Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 6MO data are reported here as the primary comparison. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State College of Medicine, Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-

Find similar trials in Hershey, PA

By condition
Type 1 diabetesType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Penn State College of Medicine, Penn State Milton S Hershey Medical Center· Hershey, PA

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