Figure Pilot Randomized Controlled Clinical Trial to Improve Adherence Barriers for Adolescents with Type 1 Diabetes
7 affiliations
- 1Cincinnati Children’s Hospital Medical Center, Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, University of Cincinnati College of Medicine, 3333 Burnet Avenue, Cincinnati, OH 45229
- 2University of Colorado Anschutz Medical Campus, School of Medicine, Department of Pediatrics, Barbara Davis Center for Diabetes, Aurora, CO 80045
- 3University of Georgia, College of Education, Athens, GA
- 4University of Windsor, Department of Psychology, Windsor, ON N9B3P4, Canada
- 5University of Florida, Department of Clinical and Health Psychology, Gainesville, FL 32610
- 6University of Florida, Department of Pediatrics, Division of Pediatric Endocrinology, College of Medicine, FL 32610
- 7Cincinnati Children’s Hospital Medical Center, Division of Endocrinology, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH
Abstract
OBJECTIVE: To examine feasibility, acceptability, satisfaction, and preliminary efficacy of Diabetes Journey (DJ), a randomized controlled clinical trial for 12- to 17-year-old adolescents with type 1 diabetes (T1D). STUDY DESIGN: = 14.8 ± 1.6 years; 56.4% female) who exceeded the clinical cut-point on the Barriers to Diabetes Adherence (BDA) questionnaire were randomized to DJ (amusement park-themed web modules) or enhanced standard of care (ESC; T1D education toolkit). Data were collected across 9 months, including baseline, posttreatment, follow-up 1 (3 months posttreatment), and follow-up 2 (6 months posttreatment). Primary outcomes were acceptability, feasibility, satisfaction, and BDA Stress/Burnout and Time Pressure/Planning scores at follow-up 1. Secondary outcomes were glycosylated hemoglobin A1c and quality of life. RESULTS: The group × time interaction was significant for the BDA Stress/Burnout subscale. Compared with ESC, the DJ group demonstrated a modest but statistically significant reduction in Stress/Burnout (b = -0.36, P < .05, 95% CI -0.72 to -0.01) and improvements in T1D quality of life (b = 7.09, P = .03, 95% CI 0.59-13.59). No significant differences occurred between groups for time pressure/planning. Adolescents and caregivers in DJ reported greater satisfaction than those in ESC. CONCLUSIONS: Our preliminary findings suggest that DJ had high acceptability, feasibility, and satisfaction. Adolescents randomized to DJ showed signals of reduced stress and burnout and improved quality of life at later follow-up, although these findings should be interpreted cautiously given attrition and the optional nature of the final follow-up assessment. TRIAL REGISTRATION: www. CLINICALTRIALS: gov NCT04404556.
Related
- Does autonomy enhance satisfaction, adherence and clinical outcomes? A Randomized Controlled Trial of a digital mental health intervention for college students
- Barriers and Facilitators Influencing Physiotherapists’ Adherence to Clinical Practice Guidelines and Return to Sport Criteria after Anterior Cruciate Ligament Reconstruction: A Qualitative Study in Austria.
- Effectiveness of behavioral interventions on knowledge, attitude, and adherence to prenatal Multiple Micro-nutrients Suplement among pregnant women in Ethiopia: a post-test only cluster randomized controlled trial
- Effectiveness of a Sequential Simulation and Online Learning Intervention on Psychiatric Mental Health Nurses’ Motivational Interviewing Knowledge, Confidence, and Skill Performance for Medication Adherence: A Cluster-randomized Controlled Trial
- A multilevel intervention to improve adherence to prostate cancer active surveillance versus usual care: results from a pilot randomized controlled trial.
BibTeX
@article{modi2026figure,
title = {{Figure Pilot Randomized Controlled Clinical Trial to Improve Adherence Barriers for Adolescents with Type 1 Diabetes}},
author = {Avani C. Modi and Constance A. Mara and Holly O’Donnell and Matthew Schmidt and Jessica C. Kichler and Laura B. Smith and Sarah C. Westen and Laura Jacobsen and Sarah D. Corathers and Desireé N. Williford and Paige J. Trojanowski and Erin Flynn and Emily R. Shaffer and Bailey Tanner and Kimberly A. Driscoll},
journal = {The Journal of pediatrics},
year = {2026},
month = may,
doi = {10.1016/j.jpeds.2026.115155},
url = {https://doi.org/10.1016/j.jpeds.2026.115155},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Figure Pilot Randomized Controlled Clinical Trial to Improve Adherence Barriers for Adolescents with Type 1 Diabetes
AU - Avani C. Modi
AU - Constance A. Mara
AU - Holly O’Donnell
AU - Matthew Schmidt
AU - Jessica C. Kichler
AU - Laura B. Smith
AU - Sarah C. Westen
AU - Laura Jacobsen
AU - Sarah D. Corathers
AU - Desireé N. Williford
AU - Paige J. Trojanowski
AU - Erin Flynn
AU - Emily R. Shaffer
AU - Bailey Tanner
AU - Kimberly A. Driscoll
PY - 2026
DA - 2026/05/22
JO - The Journal of pediatrics
DO - 10.1016/j.jpeds.2026.115155
UR - https://doi.org/10.1016/j.jpeds.2026.115155
AB - OBJECTIVE: To examine feasibility, acceptability, satisfaction, and preliminary efficacy of Diabetes Journey (DJ), a randomized controlled clinical trial for 12- to 17-year-old adolescents with type 1 diabetes (T1D). STUDY DESIGN: = 14.8 ± 1.6 years; 56.4% female) who exceeded the clinical cut-point on the Barriers to Diabetes Adherence (BDA) questionnaire were randomized to DJ (amusement park-themed web modules) or enhanced standard of care (ESC; T1D education toolkit). Data were collected across 9 months, including baseline, posttreatment, follow-up 1 (3 months posttreatment), and follow-up 2 (6 months posttreatment). Primary outcomes were acceptability, feasibility, satisfaction, and BDA Stress/Burnout and Time Pressure/Planning scores at follow-up 1. Secondary outcomes were glycosylated hemoglobin A1c and quality of life. RESULTS: The group × time interaction was significant for the BDA Stress/Burnout subscale. Compared with ESC, the DJ group demonstrated a modest but statistically significant reduction in Stress/Burnout (b = -0.36, P < .05, 95% CI -0.72 to -0.01) and improvements in T1D quality of life (b = 7.09, P = .03, 95% CI 0.59-13.59). No significant differences occurred between groups for time pressure/planning. Adolescents and caregivers in DJ reported greater satisfaction than those in ESC. CONCLUSIONS: Our preliminary findings suggest that DJ had high acceptability, feasibility, and satisfaction. Adolescents randomized to DJ showed signals of reduced stress and burnout and improved quality of life at later follow-up, although these findings should be interpreted cautiously given attrition and the optional nature of the final follow-up assessment. TRIAL REGISTRATION: www. CLINICALTRIALS: gov NCT04404556.
SN - 0022-3476
SN - 1097-6833
ER -