Clinical trial NCT04992299: Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Official title: Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Depression
Insulin Resistance
Obesity
Adolescent Development
Keywords: Adolescent Development
Obesity
Type 2 Diabetes
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of Colorado, Denver
name: Children's National Health System
name: Uniformed Services University of the Health Sciences
First posted: 2021-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Intervention Fidelity
timeFrame: 12-months
measure: Recruitment Feasibility: Percentage of Eligible Adolescents who Enroll
timeFrame: 12-months
Secondary outcomes:
measure: Training Fidelity: Facilitator Knowledge after Training
timeFrame: 6-months
measure: Training Fidelity: Facilitator Adherence and Competence during Mock Sessions
timeFrame: 6-months
measure: Recruitment Feasibility
timeFrame: 12-months
measure: Intervention Feasibility: Attendance
timeFrame: 6-weeks
measure: Intervention Acceptability: Likeability/Credibility Ratings
timeFrame: 6-weeks
measure: Intervention Acceptability: Qualitative Themes
timeFrame: 6-weeks
measure: Retention Feasibility: Percentage of Adolescents who Complete Follow-ups
timeFrame: 12-months
measure: Assessment Feasibility: Percentage Accuracy of Protocols
timeFrame: 18-months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver/Children's Hospital Colorado
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Bethesda
country: United States
facility: Uniformed Services University
state: Maryland
Study officials:
References: