Effects of a health education intervention based on the behavior change wheel on fear of hypoglycemia behavior in type 2 diabetes mellitus patients: a randomized controlled pilot trial.

Aims: To conduct a pilot randomized trial of an intervention based on the behavior change wheel (BCW) to reduce fear of hypoglycemia (FoH) behavior in person with Type 2 diabetes mellitus. Additionally, the study assessed the program's feasibility, acceptability, and preliminary effects.

Methods: This study utilized a single-blind, parallel randomized controlled trial design. The intervention included in-person education during hospitalization, online coaching post-discharge and follow-up. Effectiveness was assessed by comparing changes in primary outcomes (FoH behavior and worry), secondary outcomes (impaired hypoglycemia awareness, medical support, and self-management attitudes).

Results: Recruitment (82%) and completion rate (100%) indicated feasibility. Qualitative interviews and satisfaction surveys indicated acceptability. The intervention group significantly reduced FoH (behavior and worry) scores compared to the controls (F = 49.060-98.057, P < 0.001, η = 0.632-0.774). Also, lower impaired hypoglycemia awareness (F = 4.036, P = 0.024, η = 0.082) and improved medical support (F = 58.925, P < 0.001, η = 0.664), self-management attitudes (F = 7.931, P = 0.001, η = 0.143) were observed.

Conclusion: The BCW-based intervention is feasible, acceptable, and improves not only FoH behavior and worry, but also impaired awareness of hypoglycemia, medical support, and self-management attitudes.

Trial registration: The study was retrospective registered on ClinicalTrials.gov (identifier: NCT06197360), registration date: 05/1/2024.