# Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth with Type 1 Diabetes

> **NIH NIH R01** · CHILDREN'S RESEARCH INSTITUTE · 2024 · $753,343

## Abstract

PROJECT SUMMARY / ABSTRACT
Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regi-
men, including daily insulin administration/pump management, frequent blood glucose checks, and careful
tracking of food intake, places a high stress burden on patients. Adolescence is a risky time for T1D
management given a marked decline in treatment adherence. Over 80% of adolescents with T1D have
glycemic control that does not reach target levels (A1c 7.0%), and one significant risk factor is the increase in
negative affectivity, including depression and anxiety symptoms. Elevated depression and anxiety symptoms
affect 40% of teens with T1D. Our preliminary data support the notion that negative affectivity contributes to
diminished treatment adherence and worsening of glycemia, partially through the effects of negative
affectivity on stress-related behavior such as maladaptive eating behavior. The use of novel, targeted
interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of
coping with their chronic illness, that are translatable and able to be disseminated into clinics are needed.
Our pilot work adapted, with the collaboration of stakeholders, a 7-week, group mindfulness-based intervention
based on Learning to BREATHE, BREATHE-T1D, and a health education comparison condition, HealthEd-
T1D, for adolescents with T1D. This pilot study demonstrated the feasibility and acceptability of participation in
both groups with the ultimate goal of improving glycemic control via improvements to mood and therefore less
disordered eating, avoidant coping, less impulsivity, and better self-care. The primary goal of the current
proposal is to conduct a full-scale efficacy trial of BREATHE-T1D as compared to HealthEd-T1D across two
sites, Children’s National Hospital in Washington, DC and the University of Colorado in Denver. The study will
be a pragmatic clinical trial with another primary aim to conduct a pilot feasibility study of implementation of a
group-based intervention for negative affect via an in-clinic screening and program referral process consistent
with the Fit to Context Framework’s Design Phase. The feasibility and acceptability of the screening and
referral process will be assessed via documentation of screening rates as well as qualitative interviews and
implementation survey measures with clinic staff and providers. This goal is to evaluate the screening and
referral process into the program within the ultimate setting in which it will be delivered, if efficacious. The
result of the current study will be a feasible and acceptable clinic screening and referral process across
multiple clinics and an efficacious group-based, virtual intervention tailored for adolescents with T1D designed
for the settings in which it will ultimately be implemented. The multidisciplinary and multi-site study team
contributes complementary areas of expertise in adolescents with...

## Key facts

- **NIH application ID:** 10981344
- **Project number:** 1R01DK137859-01A1
- **Recipient organization:** CHILDREN'S RESEARCH INSTITUTE
- **Principal Investigator:** Eleanor Race Mackey
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $753,343
- **Award type:** 1
- **Project period:** 2024-09-05 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10981344

## Citation

> US National Institutes of Health, RePORTER application 10981344, Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth with Type 1 Diabetes (1R01DK137859-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10981344. Licensed CC0.

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