Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes
1 other identifier
interventional
30
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2022
CompletedFirst Submitted
Initial submission to the registry
October 7, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 7, 2025
April 1, 2025
1.8 years
October 7, 2022
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Hemoglobin A1c (HbA1c, %)
12 months
Other Outcomes (7)
Patient Health Questionnaire for Adolescents (PHQ-A)
12 months
Screen for Childhood Anxiety Related Emotional Disorders (SCARED-5) questionnaire
12 months
Problem Areas in Diabetes - Teens (PAID-T) questionnaire
12 months
- +4 more other outcomes
Study Arms (2)
Mind-body skills + diabetes education
EXPERIMENTALParticipants 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.
Diabetes education alone
ACTIVE COMPARATORParticipants randomly assigned to this arm will similarly undergo 20-30 minutes discussing the same predetermined diabetes topic as the intervention group.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosed cognitive disabilities
- Other uncontrolled chronic diseases as assessed by PI
- Inability to attend visits due to individual schedules
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Eli Lilly and Companycollaborator
Study Sites (2)
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamara S. Hannon, MD
Riley Hospital for Children at Indiana University Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
October 7, 2022
First Posted
October 13, 2022
Study Start
September 14, 2022
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
April 7, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share