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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AT011008 | U.S. NIH Grant/Contract | View source | |
| 5R01AT011008 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| University of Colorado, Denver | OTHER |
| Children's National Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Intervention | Experimental | 6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction |
|
| Cognitive-Behavioral Therapy | Active Comparator | 6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression |
|
| Health Education | Other | 6-week group program providing didactic information on adolescent health topics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Intervention | Behavioral | 6-week mindfulness-based intervention of 6 weekly 1 hour group sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Training Fidelity: Facilitator Knowledge After Training | Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd | 6-months |
| Training Fidelity: Facilitator Adherence and Competence During Mock Sessions |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver/Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
Data will be made available upon reasonable request.
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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.
The first participant was enrolled on May 5, 2022, and enrollment was completed for this trial on September 9, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Intervention | 6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction |
| FG001 | Cognitive-Behavioral Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2023 |
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| Uniformed Services University of the Health Sciences |
| FED |
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| Cognitive-Behavioral Therapy | Behavioral | 6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions |
|
| Health Education | Behavioral | 6-week health education didactic program of 6 weekly 1 hour group sessions |
|
Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd mock group sessions (1=poor to 10=exceptional)
| 6-months |
| Recruitment Feasibility | Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal | 24-months |
| Intervention Feasibility: Attendance | ≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions | 6-weeks |
| Intervention Acceptability: Likeability/Credibility Ratings | ≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely) | 6-weeks |
| Intervention Acceptability: Qualitative Themes | Themes indicative of acceptability of interventions, as derived from grounded theory/qualitative analysis of adolescent focus-groups at post-intervention | 6-weeks |
| Retention Feasibility | ≥80% at post-treatment follow-up and ≥70% at 1-year follow-up | 12-months |
| Assessment Feasibility: Percentage Accuracy of Protocols | ≥95% accuracy on standardized protocol checklists for all assessments | 18-months |
| 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 |
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
| FG002 | Health Education | 6-week group program providing didactic information on adolescent health topics |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Based Intervention | 6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction |
| BG001 | Cognitive-Behavioral Therapy | 6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression |
| BG002 | Health Education | 6-week group program providing didactic information on adolescent health topics |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI Status | Overweight or obesity based upon BMI percentile for age and sex | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Fidelity | Facilitators score ≥8 on adherence and competence ratings of MBI, CBT, and HealthEd adolescent group sessions (1=poor to 10=exceptional) | 49 total sessions were rated by experts, about 1/3 of randomly selected sessions across arms; facilitators were not considered enrolled but contributed to this assessment | Posted | Median | Inter-Quartile Range | Expert ratings ranging from 0-100% | 12-months | GroupSession | GroupSession |
|
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| ||||||||||||||||||||||||||||||||
| Primary | Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll | ≥80% eligible adolescents will enroll | 138 is the number of participants who were determined to be eligible or possibly eligible after starting the screening/baseline assessment phase; 120 out of 138=87% | Posted | Number | Number who chose to enroll | 12-months |
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| Secondary | Training Fidelity: Facilitator Knowledge After Training | Facilitators score ≥80% on post-training knowledge/ competency tests of MBI, CBT, and HealthEd | Number of facilitators who were trained in each intervention type, who scored at least 80% or higher on post-training knowledge test; facilitators were not considered enrolled but contributed to this assessment | Posted | Count of Participants | Participants | 6-months |
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| Secondary | 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) | Facilitators were not considered enrolled but contributed to this assessment; facilitators were not considered enrolled but contributed to this assessment | Posted | Median | Inter-Quartile Range | Expert ratings ranging from 0-100% | 6-months | GroupSession | GroupSession |
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| Secondary | Recruitment Feasibility | Attainment of target N=120 within a 12-month period; CONSORT flow/number of months to reach recruitment goal | Number of months it took to enroll the 120 target sample | Posted | Number | Months | 24-months |
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| Secondary | Intervention Feasibility: Attendance | ≥80% adolescents attend 5:6 (80%) group MBI/CBT/HealthEd sessions | Posted | Count of Participants | Participants | 6-weeks |
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| Secondary | Intervention Acceptability: Likeability/Credibility Ratings | ≥80% adolescent liking/credibility ratings ≥4 (1=not at all to 5=extremely) | Not Posted | May 2026 | 6-weeks | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Intervention Acceptability: Qualitative Themes | Themes indicative of acceptability of interventions, as derived from grounded theory/qualitative analysis of adolescent focus-groups at post-intervention | Not Posted | May 2026 | 6-weeks | Participants | |||||||||||||||||||||||||||||||||||||||
| Secondary | Retention Feasibility | ≥80% at post-treatment follow-up and ≥70% at 1-year follow-up | Number who completed follow-up | Posted | Count of Participants | Participants | 12-months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Assessment Feasibility: Percentage Accuracy of Protocols | ≥95% accuracy on standardized protocol checklists for all assessments | Not Posted | May 2026 | 18-months | Participants |
From baseline through end of the follow-up period, up to 1 year
All adverse events were tracked in line with standard guidelines/ClinicalTrials.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-Based Intervention | 6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction | 0 | 37 | 0 | 37 | 29 | 37 |
| EG001 | Cognitive-Behavioral Therapy | 6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression | 0 | 43 | 1 | 43 | 27 | 43 |
| EG002 | Health Education | 6-week group program providing didactic information on adolescent health topics | 0 | 40 | 0 | 40 | 35 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for psychological concerns | Psychiatric disorders | Systematic Assessment | Reported hospitalization at any point from enrollment to 1-year follow-up for psychiatric concerns |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated lab results | Metabolism and nutrition disorders | Systematic Assessment | Impaired fasting glucose or glucose tolerance at any point from baseline to 1-year follow-up |
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| Elevated blood pressure at any point from baseline to 1-year follow-up | General disorders | Systematic Assessment | Elevated resting blood pressure, values communicated to family |
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| Mental health concerns assessed at any point from baseline (within past year) to 1-year follow-up | Psychiatric disorders | Systematic Assessment | Past or current report of suicidality or self-harm or other mental health concerns that merited disclosure to parent/guardian |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Shomaker | Colorado State University | 970-491-3217 | lauren.shomaker@colostate.edu |
| Jan 13, 2026 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2022 | Jan 13, 2026 | ICF_003.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003863 | Depression |
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Obesity BMI >=95th percentile |
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