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NCT04992299 · ClinicalTrials.gov registry record · NA
Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
A NA study, sponsored by Colorado State University.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT04992299: Completed NA study, sponsored by Colorado State University.
NCT04992299 is a NA study that has completed, run by Colorado State University. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04992299, a NA study, has completed, sponsored by Colorado State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
Rates of type 2 diabetes (T2D) in adolescents have escalated. Adolescent-onset is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, a physiological precursor to T2D. T2D prevention standard-of-care is lifestyle intervention to decrease insulin resistance through weight loss; yet, this approach is insufficiently effective in adolescents. Adolescents at risk for T2D frequently experience depression, which predicts worsening insulin resistance and T2D onset, even after accounting for obesity. Mindfulness-based intervention (MBI) may offer a targeted, integrative health approach to decrease depression, and thereby, ameliorate insulin resistance in adolescents at risk for T2D. In a single-site, pilot randomized controlled trial (RCT), we established initial feasibility/acceptability of a 6-week group MBI program, Learning to BREATHE, in adolescents at risk for T2D. We demonstrated feasible single-site recruitment, randomization, retention, protocol adherence, and MBI acceptability/credibility in the target population. Our preliminary data also suggest MBI may lead to greater reductions in stress-related behavior, vs. CBT and a didactic/health education (HealthEd) control group. The current study is multisite, pilot RCT to test multisite fidelity, feasibility, and acceptability in preparation for a future multisite efficacy trial that will have strong external validity, timely recruitment, and long-term follow-up. Adolescents (N=120) at risk for T2D will be randomized to MBI vs. CBT vs. HealthEd and followed for 1-year. Specific aims are to: (1) test multisite fidelity of training and implementation of 6-week group MBI, CBT, and HealthEd, to teens at risk for T2D; (2) evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for an RCT of 6-week group MBI, CBT, HealthEd with 6-week and 1-year follow-up; and (3) modify intervention training/implemen
Primary Outcome
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)
Interventions
- BEHAVIORAL Mindfulness-Based Intervention
- BEHAVIORAL Health Education
- BEHAVIORAL Cognitive-Behavioral Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-05-05 |
| Est. Completion | 2025-05-26 |
| Phase | NA |
What the finished NCT04992299 record still lists
NCT04992299 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Mindfulness-Based Intervention is the first listed.
NCT04992299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04992299 about?
NCT04992299 is a clinical study titled "Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents". Rates of type 2 diabetes (T2D) in adolescents have escalated. Adolescent-onset is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, a physiological precursor to T2D. T2D prevention standard-of-care is l...
What is the current status of trial NCT04992299?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2022-05-05. Estimated completion is 2025-05-26.
What interventions are being tested in trial NCT04992299?
The interventions under investigation include: Mindfulness-Based Intervention (BEHAVIORAL), Health Education (BEHAVIORAL), Cognitive-Behavioral Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04992299?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04992299's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 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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