NCT04992299Completed
Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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/implementation and protocol procedures in preparation for a future, fully-powered multisite efficacy RCT.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 21 Jul 2021
- Start date
- May 2022
- Primary completion date
- Dec 2024
- Lead sponsor
- Colorado State University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT04992299
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From May 2022 to the primary completion date, Dec 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular medication use affecting mood, insulin, and/or weight: anti-anxiety medications, anti-depressants, anti-psychotics, insulin sensitizers, mood stabilizers, stimulants, and weight loss drugs
Other illness
- Major psychiatric problem: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric diagnosis, including anorexia nervosa, bipolar disorder, bulimia nervosa, conduct disorder, major depressive disorder (MDD), obsessive compulsive disorder, panic disorder, posttraumatic stress disorder, psychosis, and substance/tobacco/alcohol use disorder
Lab values
- Major medical problem: including T2D, assessed at baseline/screening as fasting glucose ≥126 mg/dL or 2-hour glucose ≥200 mg/dL, or any other significant medical condition reported during the medical history/physical examination
Other
- Active suicidal ideation or behavior
- Regular psychotherapy or structured weight loss treatment
- Pregnancy: as reported by adolescent participants (females)
Who the study is looking for
- Adolescent: Age 12-17 years
- At-risk for T2D:
- Overweight/obesity: BMI ≥85 percentile for age and sex Family history of T2D: ≥1 relative with T2D, prediabetes, or gestational diabetes in first- or second- degree relative, referring to a biological parent, sibling, aunt, uncle, or grandparent
- Elevated depression symptoms: Center for Epidemiological Studies - Depression Scale (CES-D) total score \>20
- Good general health: Medical history/physical examination
- Parent/guardian: Parent/guardian of qualifying participant
Age in the registry: 12 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Denver/Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Uniformed Services University Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Colorado State University Coordinator of this site? Confirm its status | Fort Collins | United States | Unknown status |
| Children's National Health System Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
Related publications
- Fidelity of Mindfulness Training and Delivery for Adolescent Mental and Metabolic Health.Mindfulness (N Y) · 2026 · PMID 42802734
This page is information, not medical advice. Discuss any trial with your doctor.