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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05577169
• Other study ID #: 15268
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: July 7, 2024

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 7, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Problem Areas in Diabetes - Teens (PAID-T) questionnaire	The change in the PAID-T will be measured from baseline to 12 months.	12 months
Other	Peds QL Diabetes Module questionnaire	The change in the Peds QL Diabetes Module will be measured from baseline to 12 months.	12 months
Other	Mindful Attention Awareness Scale (MAAS) questionnaire for adolescents	The change in the MAAS will be measured from baseline to 12 months.	12 months
Other	Difficulties in Emotion Regulation Scale (DERS) questionnaire	The change in the DERS will be measured from baseline to 12 months.	12 months
Other	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
Primary	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
Primary	Acceptability of intervention in the study population.	This will be measured by participant satisfaction surveys.	12 months
Secondary	Hemoglobin A1c (HbA1c, %)	The change in HbA1c will be measured from baseline to 12 months.	12 months