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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: Completed NA study, sponsored by Milton S. Hershey Medical Center.
NCT04016415 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 309 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self-Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline,
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 |
What the finished NCT04016415 record still lists
NCT04016415 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Mindfulness Based Stress Reduction is the first listed.
NCT04016415 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04016415's enrollment target sits among peer trials
309 323rd of 2000 higher than 1,678 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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