Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes

Adolescence presents a challenging time for type 1 diabetes management, and despite a multitude of studies aimed at increasing disease compliance in this age group, none have been deemed superior. The purpose of this study is to incorporate mindfulness skills in with diabetes education sessions for adolescents with type 1 diabetes and study if this translates to improved outcomes in glycemic control, patient satisfaction, and mental wellness.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Adolescent Behavior
• Intervention / Treatment: Behavioral: Mind-body skills; Behavioral: Diabetes education

Detailed Description

This is a pilot study to learn if adding mind-body skills to diabetes education is useful in helping adolescents manage their type 1 diabetes. Specifically, the investigators will be studying adolescents aged 15-17 years old with uncontrolled diabetes defined by an A1c >9.0% who have also had the diagnosis of diabetes for at least 12 months. This study combines the teaching of mind-body skills with short virtual diabetes education sessions, in order to address both the direct needs of good diabetes management and the indirect needs of coping with diabetes-related stress and other external factors. The investigators will have two arms of the study - one receiving diabetes education with the addition of mind-body skills, and the other arm receiving only diabetes education. Sessions will be conducted virtually with 20-30 minutes of diabetes education, followed by 20-30 minutes of mind-body skills teaching in the respective arm. The study will consist of 10-12 weekly group sessions, with pre- and post-study questionnaires to evaluate mental and physical health. Participants will continue to attend their regular diabetes clinic appointments every three months. At the end of the study, participants will also partake in a short interview to gather feedback about their experience. The goals of this study are to evaluate the effect of mind-body skills as well as pilot test the feasibility and acceptability of such a project.

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

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Methodist Hospital
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 15-17 years
• Diagnosis of type 1 diabetes for at least 12 months
• Uncontrolled diabetes with A1c at least 9.0%
• Parent or guardian agrees for adolescent to participate

Exclusion Criteria:

• Diagnosed cognitive disabilities
• Other uncontrolled chronic diseases as assessed by PI
• Inability to attend visits due to individual schedules

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mind-body skills + diabetes education; Participants randomly assigned to this arm will undergo 20-30 minutes discussing a predetermined diabetes topic followed by 20-30 minutes working on a mind-body skills component. This mind-body skills component will be a combination of deep breathing, self-reflection, and meditation techniques focused on self-awareness to calm the stress-response. Participants will be assigned "homework" designed to encourage practice of the learned skill.	Behavioral: Mind-body skills; The purpose of mind-body medicine is to use conscious thoughts and actions to positively impact autonomic responses from the brain as well as coping mechanisms for life's stresses. Examples of mind-body skills include deep breathing exercises, meditation, drawing, guided imagery, journaling, affirmations, and biofeedback.; Behavioral: Diabetes education; When children and adolescents are diagnosed with diabetes, education is typically focused on the parents; as our older adolescents prepare to transition to adult care with full responsibility of their health, the goal of short education sessions is to review the basics of T1D along with addressing each individual's needs and questions as they make this transition.
Active Comparator: Diabetes education alone; Participants randomly assigned to this arm will similarly undergo 20-30 minutes discussing the same predetermined diabetes topic as the intervention group.	Behavioral: Diabetes education; When children and adolescents are diagnosed with diabetes, education is typically focused on the parents; as our older adolescents prepare to transition to adult care with full responsibility of their health, the goal of short education sessions is to review the basics of T1D along with addressing each individual's needs and questions as they make this transition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of intervention in the study population.	Feasibility of recruitment, retention of participants, and intervention completion. This will be measured by considering study participation rate, time to recruit, attendance, study retention rate, study completion rate, participant burden, and data completeness.	12 months
Acceptability of intervention in the study population.	This will be measured by participant satisfaction surveys.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c (HbA1c, %)	The change in HbA1c will be measured from baseline to 12 months.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire for Adolescents (PHQ-A)	Measure of general health and wellbeing. The change in the PHQ-A will be measured from baseline to 12 months.	12 months
Screen for Childhood Anxiety Related Emotional Disorders (SCARED-5) questionnaire	The change in the SCARED-5 will be measured from baseline to 12 months.	12 months
Problem Areas in Diabetes - Teens (PAID-T) questionnaire	The change in the PAID-T will be measured from baseline to 12 months.	12 months
Peds QL Diabetes Module questionnaire	The change in the Peds QL Diabetes Module will be measured from baseline to 12 months.	12 months
Mindful Attention Awareness Scale (MAAS) questionnaire for adolescents	The change in the MAAS will be measured from baseline to 12 months.	12 months
Difficulties in Emotion Regulation Scale (DERS) questionnaire	The change in the DERS will be measured from baseline to 12 months.	12 months
Child and Adolescent Social Support Scale (CASSS) questionnaire	The change in the parent and friends subscales of the CASSS will be measured from baseline to 12 months.	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Tamara S. Hannon, MD, Riley Hospital for Children at Indiana University Health

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Type 1 diabetes; Mind-body skills
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 15268 (UKCRN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No