NCT04992299

Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Colorado State University · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes
• Depression
• Insulin Resistance
• Obesity
• Adolescent Development

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Intervention	6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
BEHAVIORAL	Cognitive-Behavioral Therapy	6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
BEHAVIORAL	Health Education	6-week health education didactic program of 6 weekly 1 hour group sessions

Timeline

• Start date: 2022-05-05
• Primary completion: 2024-12-21
• Completion: 2025-05-26
• First posted: 2021-08-05
• Last updated: 2026-04-02
• Results posted: 2026-04-02

Locations

4 sites across 1 country: United States