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

NCT07270900 | Completed

• 1 other identifier: 21496
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Prediabetes

Keywords

mindfulness based intervention

Outcome Measures

Primary Outcomes (7)

• 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: 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?

  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 Outcomes (3)

• Height from electronic medical record

  12 months

• HbA1c from electronic medical record

  12 months

• Weight from the electronic medical record

  12 months

Other Outcomes (6)

• Anxiety symptoms

  12 months

• Depression symptoms

  12 months

• Perceived Stress Scale

  12 months

Study Arms (1)

Learn to Breathe Group Program

EXPERIMENTAL

All study participants take part in the L2B MBI

Procedure: Mindfulness Based Group

Interventions

Mindfulness Based Group PROCEDURE

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).

Learn to Breathe Group Program

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Diagnosed cognitive disabilities
• Inability to attend visits due to individual schedules

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Diabetes CLinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tamara S Hannon, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 8, 2025
• Study Start: February 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)