Prediabetes, Type 2 Diabetes
Conditions
Keywords
mindfulness based intervention
Brief summary
The purpose of this study is to conduct a mindfulness-based intervention for adolescents referred for prediabetes or type 2 diabetes treatment to 1) evaluate feasibility and acceptability of the intervention for future research and clinical use and 2) explore secondary health outcomes related to diabetes prevention and care.
Detailed description
Background and Rationale Mindfulness-based interventions (MBI) may offer additional benefits to traditional health care for youth living with prediabetes or T2D. MBIs teach skills to increase present moment attention and adopt a nonjudgmental attitude towards one's experience which can foster healthy stress coping behaviors and greater self-regulation; both of which are associated with improved diabetes self-care behaviors. MBIs were introduced to the clinical population in the 1970's and have been translated for a variety of populations and health conditions including diabetes. MBIs may be a promising complementary approach for T2D prevention and treatment in youth, and thus, warrant further investigation. Specific Aims Aim 1: Pilot test the feasibility and acceptability of a mindfulness-based intervention in adolescents with prediabetes or type 2 diabetes. Aim 2: Explore secondary physical and mental health outcomes of the study cohorts. Enrollment The investigators aim to recruit 50 individuals with the goal of at least 20 participants to complete the study (two groups of 10 participants). Recruitment Sites: Diabetes care providers see patients in an outpatient setting at Riley Specialty Care at IU Health Methodist in Indianapolis, Indiana. Additional outreach clinics available for participant recruitment include Riley Specialty Care at Riley Outpatient Center, IU North, Bloomington, Fort Wayne, and South Bend. Study Procedures Following enrollment, participants will complete baseline surveys and begin attending the 12-week MBI. Participants will complete surveys following completion of the MBI and at the 12-month follow up. Intervention The MBI will be conducted in a virtual group setting by Zoom, with a target size of 8-12 participants. Groups may vary in size based on session attendance. The MBI will follow the Learning to BREATHE (L2B) curriculum. L2B is a manualized 12-week curriculum that teaches a variety of mindfulness skills including breath awareness, body scanning, mindful eating, sitting meditation, loving kindness practice, and mindful movement. Weekly group sessions will last 45-60 minutes. Participants will be invited to engage in daily practice of mindfulness skills (home practice). This study includes a post-intervention group guided interview at 12-weeks. The facilitator will ask the group for feedback about the intervention with the following questions: 1) What did you like about participating in this study? 2) What did you dislike about participating in this study? 3) What were your expectations from participating in this study? 4) Were those expectations met? The investigators will describe the results of participants using quantitative data (results of surveys and numerical clinical information from HbA1c and BMI) and qualitative data (results from interviews). This study will be important to serve as the foundation for a fully powered clinical trial of MBI in type 2 diabetes and prediabetes.
Interventions
PROCEDUREMindfulness Based Group
L2B is a manualized 12-week curriculum that teaches a variety of mindfulness skills including breath awareness, body scanning, mindful eating, sitting meditation, loving kindness practice, and mindful movement. Weekly group sessions will last 45-60 minutes. Participants will be invited to engage in daily practice of mindfulness skills (home practice).
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 12-18 years * Referred to clinic for treatment of prediabetes or type 2 diabetes * English speaking
Exclusion criteria
* • Diagnosed cognitive disabilities * Inability to attend visits due to individual schedules
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion | 12 months | Study Completion Rate: Number of participants who complete all assessments divided by the number of participants enrolled in the study arm. |
| Acceptability | 12 months | L2B Program Questionnaires Post-study guided interview: 1. What did you like about participating in this study? 2. What did you dislike about participating in this study? 3. What were your expectations from participating in this study? 4. Were those expectations met? |
| Participation | 3 months | Study Participation Rate: Number of participants who consented to take part in the study divided by the number of patients approached. We will also document reasons for refusal to participate in the study. |
| Retention | 12 months | Study Retention Rate: Number of participants in a study arm who remain in the study and maintain communication with study staff (regardless of session attendance) divided by the number of participants enrolled in the study. |
| Attendance | 4 months | Attendance: Attendance at each intervention session will be recorded. |
| Recruitment | 3 months | Time to Recruit: Time required to attain the needed sample for each recruitment wave |
| Data Completeness | 12 months | Data Completeness: Percentage of questionnaires/study measures completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight from the electronic medical record | 12 months | Weight in kilograms from the electronic medical record |
| Height from electronic medical record | 12 months | Height in centimeters from electronic medical record |
| HbA1c from electronic medical record | 12 months | HbA1c from electronic medical record |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety symptoms | 12 months | Screen for Childhood Anxiety Related Emotional Disorders (SCARED-5); 5 items; A score of ≥3 indicates the possibility of anxiety. |
| Emotion regulation | 12 months | Difficulties in Emotion Regulation Scale (DERS); 36 items; higher scores indicate more difficulties with emotion regulation. |
| Mindful attention awareness | 12 months | Mindful Attention Awareness Scale (MAAS); 15 items; higher scores indicate more mindful attention awareness. |
| Health-related quality of life | 12 months | Peds QL Generic Core Scales: 23 Items; generic Core Scales scores are transformed on a scale from 0-100 with higher scores indicating higher health-related quality of life. |
| Perceived Stress Scale | 12 months | Perceived Stress Scale (PSS-10): 10 items; score 0-40; higher scores indicate more stress. |
| Depression symptoms | 12 months | Depression-Pediatric Item Bank (PROMIS) - 14 items; A T-score of 50 is the mean; higher scores indicate more depressive symptoms. |
Countries
United States
Outcome results
None listed