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

Not Applicable

Completed

• Conditions: Adolescent Behavior; Type 1 Diabetes

• Registration Number: NCT05577169
• Lead Sponsor: Indiana University

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.

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 Timeline

• Study Start: 2022-09-14
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of intervention in the study population.	12 months	This will be measured by participant satisfaction surveys.
Feasibility of intervention in the study population.	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c, %)	12 months	The change in HbA1c will be measured from baseline to 12 months.

Trial Locations

Locations (2)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States