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Aims <p>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.</p> Methods <p>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).</p> Results <p>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 (<i>F</i> = 49.060–98.057, <i>P</i> &lt; 0.001, η = 0.632–0.774). Also, lower impaired hypoglycemia awareness (<i>F</i> = 4.036, <i>P</i> = 0.024, η = 0.082) and improved medical support (<i>F</i> = 58.925, <i>P</i> &lt; 0.001, η = 0.664), self-management attitudes (<i>F</i> = 7.931, <i>P</i> = 0.001, η = 0.143) were observed.</p> Conclusion <p>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.</p> Trial registration <p>The study was retrospective registered on ClinicalTrials.gov (identifier: NCT06197360), registration date: 05/1/2024.</p>

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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

  • 期刊论文

  • 发表日期：

    2025年6月23日

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  • Yueqi Zhao,
  • Lu Zhang,
  • Juan Pang,
  • Jiahui Qiu,
  • Yuying He,
  • Ziwei Xu,
  • Mengyao Han,
  • Lin Liu,
  • Xiaojuan Wan,
  • Jinping Wang,
  • Yu Zhang

摘要

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.