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NCT04016415 · ClinicalTrials.gov registry record · NA
Decreasing Stress in Diabetes
A NA study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 309
- Enrollment target
NCT04016415 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 309 participants.
The verdict
NCT04016415, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 309 participants
- Enrollment target
Study Summary
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).
Interventions
- BEHAVIORAL Mindfulness Based Stress Reduction
- BEHAVIORAL Stress Management Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2024-08-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04016415
The ClinicalTrials.gov registry entry for NCT04016415 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mindfulness Based Stress Reduction is the first listed.
NCT04016415 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04016415 about?
NCT04016415 is a clinical study titled "Decreasing Stress in Diabetes". 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 ty...
What is the current status of trial NCT04016415?
This trial is currently completed. It is a NA study. The enrollment target is 309 participants. The study started on 2020-07-28. Estimated completion is 2024-08-09.
What interventions are being tested in trial NCT04016415?
The interventions under investigation include: Mindfulness Based Stress Reduction (BEHAVIORAL), Stress Management Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT04016415?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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