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NCT05268393 · ClinicalTrials.gov registry record · NA
Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes
A NA study, sponsored by Children's National Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT05268393: Completed NA study, sponsored by Children's National Research Institute.
NCT05268393 is a NA study that has completed, run by Children's National Research Institute. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05268393, a NA study, has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and glycemic control. Over 80% of adolescents with T1D have poor glycemic control (A1c \>7.5%), and one significant risk factor is the increase in negative affectivity, including depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Preliminary data support the notion that negative affectivity contributes to diminished treatment adherence and worsening of glycemic control, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). There is no gold-standard approach to address the poor glycemic control seen in adolescents with T1D. The creation of novel, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of coping with their chronic illness, are needed. Mindfulness-based interventions delivered to adolescents without T1D, including the team's preliminary work in teens with depression and weight-related disorders, have shown promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A mindfulness-based approach may be well-suited for adolescents with T1D, but given that the mechanisms of association among negative affectivity, stress-related behavior, and self-care are unique to individuals with T1D, interventions must be specifically tailored for this population. The goal of this study is to, therefore, adapt an existing 6-session mindfu
Primary Outcome
The percentage is calculated first by identifying the number of enrolled participants divided by eligible participants. 42 total patients were eligible once screened across the 10 month enrollment period. 42 total then enrolled in the study.
Interventions
- BEHAVIORAL BREATHE-T1D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2023-07-31 |
| Phase | NA |
What the finished NCT05268393 record still lists
NCT05268393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which BREATHE-T1D is the first listed.
NCT05268393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05268393 about?
NCT05268393 is a clinical study titled "Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes". Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Ado...
What is the current status of trial NCT05268393?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2022-03-31. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT05268393?
The interventions under investigation include: BREATHE-T1D (BEHAVIORAL).
Who is sponsoring clinical trial NCT05268393?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05268393's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 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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