N/A
N=120
Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Type 2 Diabetes · Depression · Insulin Resistance · Obesity · Adolescent Development
Bottom Line
View on ClinicalTrials.gov: NCT04992299 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Apr 2026
Primary outcome: Primary: Intervention Fidelity — 90; 90; 97.5; 100 Expert ratings ranging from 0-100%
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-Based Intervention (Behavioral); Cognitive-Behavioral Therapy (Behavioral); Health Education (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Colorado State University
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Fidelity |
90; 90; 97.5; 100; 90.5; 96 | — |
| PRIMARY Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll |
120 | — |
| SECONDARY Training Fidelity: Facilitator Knowledge After Training |
11; 10; 9 | — |
| SECONDARY Training Fidelity: Facilitator Adherence and Competence During Mock Sessions |
80; 86; 82.5; 85; 90; 80 | — |
| SECONDARY Recruitment Feasibility |
16 | — |
| SECONDARY Intervention Feasibility: Attendance |
32; 31; 30 | — |
| SECONDARY Intervention Acceptability: Likeability/Credibility Ratings |
— | — |
| SECONDARY Intervention Acceptability: Qualitative Themes |
— | — |
| SECONDARY Retention Feasibility |
35; 33; 38; 31; 31; 38 | — |
| SECONDARY Assessment Feasibility: Percentage Accuracy of Protocols |
— | — |
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/implementation and protocol procedures in preparation for a future, fully-powered multisite efficacy RCT.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
- 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
- Active suicidal ideation or behavior
- Regular psychotherapy or structured weight loss treatment
- Pregnancy: as reported by adolescent participants (females)
Data sourced from ClinicalTrials.gov (NCT04992299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.