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

NCT ID: NCT07270900

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-07-30

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.

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.

Conditions

Type 2 Diabetes; Prediabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Learn to Breathe Group Program

All study participants take part in the L2B MBI

Group Type: EXPERIMENTAL

Mindfulness Based Group

Intervention Type: 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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tamara S. Hannon

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamara S Hannon, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Riley Diabetes CLinic

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21496

Identifier Type: -

Identifier Source: org_study_id