A Mindfulness-based Intervention for Adolescents With Prediabetes or Type 2 Diabetes (L2BT2D)

The purpose of this study is to conduct a mindfulness-based intervention for adolescents referred for prediabetes or type 2 diabetes treatment to 1) evaluate feasibility and acceptability of the intervention for future research and clinical use and 2) explore secondary health outcomes related to diabetes prevention and care.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Prediabetes
• Intervention / Treatment: Procedure: Mindfulness Based Group

Detailed Description

Background and Rationale Mindfulness-based interventions (MBI) may offer additional benefits to traditional health care for youth living with prediabetes or T2D. MBIs teach skills to increase present moment attention and adopt a nonjudgmental attitude towards one's experience which can foster healthy stress coping behaviors and greater self-regulation; both of which are associated with improved diabetes self-care behaviors. MBIs were introduced to the clinical population in the 1970's and have been translated for a variety of populations and health conditions including diabetes. MBIs may be a promising complementary approach for T2D prevention and treatment in youth, and thus, warrant further investigation.

Specific Aims Aim 1: Pilot test the feasibility and acceptability of a mindfulness-based intervention in adolescents with prediabetes or type 2 diabetes.

Aim 2: Explore secondary physical and mental health outcomes of the study cohorts.

Enrollment The investigators aim to recruit 50 individuals with the goal of at least 20 participants to complete the study (two groups of 10 participants).

Recruitment Sites: Diabetes care providers see patients in an outpatient setting at Riley Specialty Care at IU Health Methodist in Indianapolis, Indiana. Additional outreach clinics available for participant recruitment include Riley Specialty Care at Riley Outpatient Center, IU North, Bloomington, Fort Wayne, and South Bend.

Study Procedures Following enrollment, participants will complete baseline surveys and begin attending the 12-week MBI. Participants will complete surveys following completion of the MBI and at the 12-month follow up.

Intervention The MBI will be conducted in a virtual group setting by Zoom, with a target size of 8-12 participants. Groups may vary in size based on session attendance. The MBI will follow the Learning to BREATHE (L2B) curriculum. L2B is a manualized 12-week curriculum that teaches a variety of mindfulness skills including breath awareness, body scanning, mindful eating, sitting meditation, loving kindness practice, and mindful movement. Weekly group sessions will last 45-60 minutes. Participants will be invited to engage in daily practice of mindfulness skills (home practice). This study includes a post-intervention group guided interview at 12-weeks. The facilitator will ask the group for feedback about the intervention with the following questions: 1) What did you like about participating in this study? 2) What did you dislike about participating in this study? 3) What were your expectations from participating in this study? 4) Were those expectations met?

The investigators will describe the results of participants using quantitative data (results of surveys and numerical clinical information from HbA1c and BMI) and qualitative data (results from interviews).

This study will be important to serve as the foundation for a fully powered clinical trial of MBI in type 2 diabetes and prediabetes.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Diabetes CLinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 12-18 years
• Referred to clinic for treatment of prediabetes or type 2 diabetes
• English speaking

Exclusion Criteria:

• • Diagnosed cognitive disabilities

  • Inability to attend visits due to individual schedules

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Learn to Breathe Group Program; All study participants take part in the L2B MBI	Procedure: Mindfulness Based Group; L2B is a manualized 12-week curriculum that teaches a variety of mindfulness skills including breath awareness, body scanning, mindful eating, sitting meditation, loving kindness practice, and mindful movement. Weekly group sessions will last 45-60 minutes. Participants will be invited to engage in daily practice of mindfulness skills (home practice).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation	Study Participation Rate: Number of participants who consented to take part in the study divided by the number of patients approached. We will also document reasons for refusal to participate in the study.	3 months
Acceptability	L2B Program Questionnaires Post-study guided interview: What did you like about participating in this study?; What did you dislike about participating in this study?; What were your expectations from participating in this study?; Were those expectations met?	12 months
Recruitment	Time to Recruit: Time required to attain the needed sample for each recruitment wave	3 months
Attendance	Attendance: Attendance at each intervention session will be recorded.	4 months
Retention	Study Retention Rate: Number of participants in a study arm who remain in the study and maintain communication with study staff (regardless of session attendance) divided by the number of participants enrolled in the study.	12 months
Completion	Study Completion Rate: Number of participants who complete all assessments divided by the number of participants enrolled in the study arm.	12 months
Data Completeness	Data Completeness: Percentage of questionnaires/study measures completed.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height from electronic medical record	Height in centimeters from electronic medical record	12 months
HbA1c from electronic medical record	HbA1c from electronic medical record	12 months
Weight from the electronic medical record	Weight in kilograms from the electronic medical record	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptoms	Screen for Childhood Anxiety Related Emotional Disorders (SCARED-5); 5 items; A score of ≥3 indicates the possibility of anxiety.	12 months
Depression symptoms	Depression-Pediatric Item Bank (PROMIS) - 14 items; A T-score of 50 is the mean; higher scores indicate more depressive symptoms.	12 months
Perceived Stress Scale	Perceived Stress Scale (PSS-10): 10 items; score 0-40; higher scores indicate more stress.	12 months
Health-related quality of life	Peds QL Generic Core Scales: 23 Items; generic Core Scales scores are transformed on a scale from 0-100 with higher scores indicating higher health-related quality of life.	12 months
Mindful attention awareness	Mindful Attention Awareness Scale (MAAS); 15 items; higher scores indicate more mindful attention awareness.	12 months
Emotion regulation	Difficulties in Emotion Regulation Scale (DERS); 36 items; higher scores indicate more difficulties with emotion regulation.	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Tamara S Hannon, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness based intervention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: 21496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared, as the data for this study is strictly confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No