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

Primary Purpose

Type 1 Diabetes, Adolescent Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind-body skills
Diabetes education
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Adolescents, Mind-body skills

Eligibility Criteria

15 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Health Methodist HospitalRecruiting
  • Riley Hospital for ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mind-body skills + diabetes education

Diabetes education alone

Arm Description

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.

Participants randomly assigned to this arm will similarly undergo 20-30 minutes discussing the same predetermined diabetes topic as the intervention group.

Outcomes

Primary Outcome Measures

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.
Acceptability of intervention in the study population.
This will be measured by participant satisfaction surveys.

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2022
Last Updated
October 24, 2023
Sponsor
Indiana University
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05577169
Brief Title
Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes
Official Title
Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Adolescent Behavior
Keywords
Type 1 diabetes, Adolescents, Mind-body skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will have two arms - one group will receive diabetes education with the addition of mind-body skills, and the other group will receive only diabetes education.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mind-body skills + diabetes education
Arm Type
Experimental
Arm Description
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.
Arm Title
Diabetes education alone
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to this arm will similarly undergo 20-30 minutes discussing the same predetermined diabetes topic as the intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Mind-body skills
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of intervention in the study population.
Description
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.
Time Frame
12 months
Title
Acceptability of intervention in the study population.
Description
This will be measured by participant satisfaction surveys.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c, %)
Description
The change in HbA1c will be measured from baseline to 12 months.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Patient Health Questionnaire for Adolescents (PHQ-A)
Description
Measure of general health and wellbeing. The change in the PHQ-A will be measured from baseline to 12 months.
Time Frame
12 months
Title
Screen for Childhood Anxiety Related Emotional Disorders (SCARED-5) questionnaire
Description
The change in the SCARED-5 will be measured from baseline to 12 months.
Time Frame
12 months
Title
Problem Areas in Diabetes - Teens (PAID-T) questionnaire
Description
The change in the PAID-T will be measured from baseline to 12 months.
Time Frame
12 months
Title
Peds QL Diabetes Module questionnaire
Description
The change in the Peds QL Diabetes Module will be measured from baseline to 12 months.
Time Frame
12 months
Title
Mindful Attention Awareness Scale (MAAS) questionnaire for adolescents
Description
The change in the MAAS will be measured from baseline to 12 months.
Time Frame
12 months
Title
Difficulties in Emotion Regulation Scale (DERS) questionnaire
Description
The change in the DERS will be measured from baseline to 12 months.
Time Frame
12 months
Title
Child and Adolescent Social Support Scale (CASSS) questionnaire
Description
The change in the parent and friends subscales of the CASSS will be measured from baseline to 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren A. Ray, MD
Phone
317-944-3889
Email
laulogan@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara S. Hannon, MD
Phone
317-944-3889
Email
tshannon@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara S. Hannon, MD
Organizational Affiliation
Riley Hospital for Children at Indiana University Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren A. Ray, MD
Phone
317-944-3889
Email
laulogan@iu.edu
First Name & Middle Initial & Last Name & Degree
Tamara S. Hannon, MD
Phone
317-944-3889
Email
tshannon@iu.edu
First Name & Middle Initial & Last Name & Degree
Tamara S. Hannon, MD
First Name & Middle Initial & Last Name & Degree
Lauren A. Ray, MD
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren A. Ray, MD
Phone
317-944-3889
Email
laulogan@iu.edu
First Name & Middle Initial & Last Name & Degree
Tamara S. Hannon, MD
Phone
317-944-3889
Email
tshannon@iu.edu
First Name & Middle Initial & Last Name & Degree
Tamara S. Hannon, MD
First Name & Middle Initial & Last Name & Degree
Lauren A. Ray, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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