An interventional study of Mindfulness-Based Intervention and Cognitive-Behavioral Therapy in Type 2 Diabetes, Depression and Insulin Resistance, sponsored by Colorado State University. Completed at 4 sites in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Colorado State University · Not applicable, Interventional, and Prevention
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Colorado State University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
Behavioral: Mindfulness-Based Intervention
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
Behavioral: Cognitive-Behavioral Therapy
6-week group program providing didactic information on adolescent health topics
Behavioral: Health Education
6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
6-week health education didactic program of 6 weekly 1 hour group sessions
Intervention Fidelity
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)
Time frame: 12-months
Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll
≥80% eligible adolescents will enroll
Time frame: 12-months
Training Fidelity: Facilitator Knowledge After Training
Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd
Time frame: 6-months
Training Fidelity: Facilitator Adherence and Competence During Mock Sessions
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional)
Time frame: 6-months
Recruitment Feasibility
Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal
Time frame: 24-months
Intervention Feasibility: Attendance
≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions
Time frame: 6-weeks
Intervention Acceptability: Likeability Ratings
≥80% adolescent liking ratings ≥4 (1=not at all to 5=extremely)
Time frame: 6-weeks
Retention Feasibility
≥80% at post-treatment follow-up and ≥70% at 1-year follow-up
Time frame: 12-months
Percentage Accuracy of Protocols
≥95% accuracy on standardized protocol checklists for all assessments
Time frame: 18-months
Intervention Acceptability: Credibility Ratings
≥80% adolescent credibility/helpfulness ratings ≥4 (1=not at all to 5=extremely)
Time frame: 6-weeks
The first participant was enrolled on May 5, 2022, and enrollment was completed for this trial on September 9, 2023.
| Milestone | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Started | 37 | 43 | 40 |
| Completed | 31 | 31 | 38 |
| Not completed | 6 | 12 | 2 |
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)
| Expert ratings ranging from 0-100% | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Facilitator Competence | 90 (80 to 100) | 90 (80 to 92.5) | 97.5 (90 to 100) |
| Facilitator Adherence | 100 (95 to 100) | 90.5 (90 to 92.5) | 96 (90 to 100) |
≥80% eligible adolescents will enroll
| Number who chose to enroll | Total Who Enrolled |
|---|---|
| Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll | 120 |
Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd
| Participants | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Training Fidelity: Facilitator Knowledge After Training | 11 | 10 | 9 |
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional)
| Expert ratings ranging from 0-100% | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Facilitator Competence | 80 (80 to 85) | 86 (85 to 87.5) | 82.5 (80 to 93.8) |
| Facilitator Adherence | 85 (80 to 90) | 90 (90 to 92) | 80 (80 to 92) |
Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal
| Months | Total Sample |
|---|---|
| Recruitment Feasibility | 16 |
≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions
| Participants | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Intervention Feasibility: Attendance | 32 | 31 | 30 |
≥80% adolescent liking ratings ≥4 (1=not at all to 5=extremely)
| Percentage | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Intervention Acceptability: Likeability Ratings | 58.8 | 55.9 | 62.8 |
≥80% at post-treatment follow-up and ≥70% at 1-year follow-up
| Participants | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| 6-week/post-intervention follow-up | 35 | 33 | 38 |
| 1-year follow-up | 31 | 31 | 38 |
≥95% accuracy on standardized protocol checklists for all assessments
Results for this outcome have not been posted.
≥80% adolescent credibility/helpfulness ratings ≥4 (1=not at all to 5=extremely)
| Percentage | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Intervention Acceptability: Credibility Ratings | 50 | 73.5 | 62.9 |
Collected over From baseline through end of the follow-up period, up to 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mindfulness-Based Intervention | 0/37 (0%) | 0/37 (0%) | 29/37 (78.4%) |
| Cognitive-Behavioral Therapy | 0/43 (0%) | 1/43 (2.3%) | 27/43 (62.8%) |
| Health Education | 0/40 (0%) | 0/40 (0%) | 35/40 (87.5%) |
| Event | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Hospitalization for psychological concernsPsychiatric disorders | 0/37 | 1/43 | 0/40 |
| Event | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education |
|---|---|---|---|
| Elevated lab resultsMetabolism and nutrition disorders | 19/37 | 15/43 | 26/40 |
| Mental health concerns assessed at any point from baseline (within past year) to 1-year follow-upPsychiatric disorders | 16/37 | 17/43 | 22/40 |
| Elevated blood pressure at any point from baseline to 1-year follow-upGeneral disorders | 4/37 | 4/43 | 8/40 |
| Age, Categorical(Participants) | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education | Total |
|---|---|---|---|---|
| <=18 years | 37 | 43 | 40 | 120 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education | Total |
|---|---|---|---|---|
| Female | 22 | 25 | 23 | 70 |
| Male | 15 | 18 | 17 | 50 |
| Ethnicity (NIH/OMB)(Participants) | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education | Total |
|---|---|---|---|---|
| Hispanic or Latino | 17 | 19 | 18 | 54 |
| Not Hispanic or Latino | 20 | 24 | 22 | 66 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| BMI Status(Participants) | Mindfulness-Based Intervention | Cognitive-Behavioral Therapy | Health Education | Total |
|---|---|---|---|---|
| Overweight BMI 85-94th percentile | 9 | 7 | 7 | 23 |
| Obesity BMI >=95th percentile | 28 | 36 | 33 | 97 |
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Plan to share: No — Data will be made available upon reasonable request.
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Colorado State University