Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
3 other identifiers
interventional
120
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started May 2022
Typical duration for not_applicable type-2-diabetes
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2021
CompletedFirst Posted
Study publicly available on registry
August 5, 2021
CompletedStudy Start
First participant enrolled
May 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2025
CompletedResults Posted
Study results publicly available
April 2, 2026
CompletedApril 2, 2026
March 1, 2026
2.6 years
July 21, 2021
January 14, 2026
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Intervention Fidelity
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional)
12-months
Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll
≥80% eligible adolescents will enroll
12-months
Secondary Outcomes (8)
Training Fidelity: Facilitator Knowledge After Training
6-months
Training Fidelity: Facilitator Adherence and Competence During Mock Sessions
6-months
Recruitment Feasibility
24-months
Intervention Feasibility: Attendance
6-weeks
Intervention Acceptability: Likeability/Credibility Ratings
6-weeks
- +3 more secondary outcomes
Study Arms (3)
Mindfulness-Based Intervention
EXPERIMENTAL6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
Cognitive-Behavioral Therapy
ACTIVE COMPARATOR6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
Health Education
OTHER6-week group program providing didactic information on adolescent health topics
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Colorado Denver/Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Colorado State University
Fort Collins, Colorado, 80523, United States
Children's National Health System
Washington D.C., District of Columbia, 20010, United States
Uniformed Services University
Bethesda, Maryland, 20814, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
By design, this multisite pilot and feasibility randomized controlled trial was centered on the assessment of training and implementation fidelity and feasibility and acceptability of the study protocol and interventions. Intervention effects cannot be determined until a powered trial is undertaken.
Results Point of Contact
- Title
- Lauren Shomaker
- Organization
- Colorado State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2021
First Posted
August 5, 2021
Study Start
May 5, 2022
Primary Completion
December 21, 2024
Study Completion
May 26, 2025
Last Updated
April 2, 2026
Results First Posted
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Data will be made available upon reasonable request.