Adolescent Development, Depression, Insulin Resistance, Obesity, Type 2 Diabetes
Conditions
Keywords
Adolescent Development, Obesity, Type 2 Diabetes
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.
Interventions
BEHAVIORALMindfulness-Based Intervention
6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
BEHAVIORALCognitive-Behavioral Therapy
6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
BEHAVIORALHealth Education
6-week health education didactic program of 6 weekly 1 hour group sessions
Sponsors
University of Colorado, Denver
Children's National Research Institute
Uniformed Services University of the Health Sciences
Colorado State University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Fidelity | 12-months | Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional) |
| Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll | 12-months | ≥80% eligible adolescents will enroll |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Training Fidelity: Facilitator Knowledge After Training | 6-months | Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd |
| Training Fidelity: Facilitator Adherence and Competence During Mock Sessions | 6-months | Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional) |
| Recruitment Feasibility | 24-months | Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal |
| Intervention Feasibility: Attendance | 6-weeks | ≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions |
| Intervention Acceptability: Likeability Ratings | 6-weeks | ≥80% adolescent liking ratings ≥4 (1=not at all to 5=extremely) |
| Retention Feasibility | 12-months | ≥80% at post-treatment follow-up and ≥70% at 1-year follow-up |
| Percentage Accuracy of Protocols | 18-months | ≥95% accuracy on standardized protocol checklists for all assessments |
| Intervention Acceptability: Credibility Ratings | 6-weeks | ≥80% adolescent credibility/helpfulness ratings ≥4 (1=not at all to 5=extremely) |
Countries
United States
Participant flow
Recruitment details
The first participant was enrolled on May 5, 2022, and enrollment was completed for this trial on September 9, 2023.
Pre-assignment details
994 phone pre-screens were initiated. 160 of these were estimated to be eligible and proceeded to the screening phase. Of these, 22 were determined to be ineligible and 18 either did not complete the screening process or declined to continue in the study prior to randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 120 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| BMI Status Obesity BMI >=95th percentile | 33 Participants |
| BMI Status Overweight BMI 85-94th percentile | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 43 | 0 / 40 |
| other Total, other adverse events | 29 / 37 | 27 / 43 | 35 / 40 |
| serious Total, serious adverse events | 0 / 37 | 1 / 43 | 0 / 40 |
Outcome results
None listed