在全科医疗中实施的移动健康干预措施，以增加糖尿病前期和2型糖尿病患者的身体活动并减少久坐行为（ENERGISED）：统计分析计划

mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): statistical analysis plan.

作者信息

Vetrovsky Tomas, Kral Norbert, Pfeiferova Marketa, Seifert Bohumil, Capek Vaclav, Jurkova Katerina, Steffl Michal, Cimler Richard, Kuhnova Jitka, Harris Tess, Ussher Michael, Wahlich Charlotte, Malisova Katerina, Pelclova Jana, Dygryn Jan, Elavsky Steriani, Maes Iris, Van Dyck Delfien, Rowlands Alex, Yates Tom

机构信息

Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.

Institute of General Practice, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.

出版信息

Trials. 2025 May 20;26(1):166. doi: 10.1186/s13063-025-08865-z.

DOI:10.1186/s13063-025-08865-z

PMID:40394706

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12093599/

Abstract

BACKGROUND

Type 2 diabetes and prediabetes represent significant global health challenges, with physical activity (PA) being essential for disease management and prevention. Despite the well-documented benefits, many individuals with (pre)diabetes remain insufficiently active. General practitioners (GP) provide an accessible platform for delivering interventions; however, integrating PA interventions into routine care is hindered by resource constraints.

OBJECTIVES

The ENERGISED trial aims to address these barriers through an innovative GP-initiated mHealth intervention combining wearable technology and just-in-time adaptive interventions.

METHODS

The ENERGISED trial is a pragmatic, 12-month, multicentre, randomised controlled trial, assessing a GP-initiated mHealth intervention to increase PA and reduce sedentary behaviour in patients with type 2 diabetes and prediabetes. The primary outcome is daily step count, assessed via wrist-worn accelerometry. The primary analysis follows the intention-to-treat principle, using mixed models for repeated measures. Missing data will be handled under the missing-at-random assumption, with sensitivity analyses exploring robustness through reference-based multiple imputation. The trial incorporates the estimand framework to provide transparent and structured treatment effect estimation.

DISCUSSION

This statistical analysis plan outlines a robust approach to addressing participant non-adherence, protocol violations, and missing data. By adopting the estimand framework and pre-specified sensitivity analyses, the plan ensures methodological rigour while enhancing the interpretability and applicability of results.

CONCLUSIONS

The ENERGISED trial leverages innovative mHealth strategies within primary care to promote PA in individuals with (pre)diabetes. The pre-specified statistical framework provides a comprehensive guide for analysing trial data and contributes to advancing best practices in behavioural intervention trials for public health.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05351359 . Registered on April 28, 2022.

摘要

背景

2型糖尿病和糖尿病前期是重大的全球健康挑战，身体活动对于疾病管理和预防至关重要。尽管益处已得到充分证明，但许多糖尿病（前期）患者的活动量仍然不足。全科医生（GP）提供了一个便于实施干预措施的平台；然而，资源限制阻碍了将身体活动干预措施纳入常规护理。

目的

ENERGISED试验旨在通过一种创新的由全科医生发起的移动健康干预措施来克服这些障碍，该干预措施结合了可穿戴技术和即时自适应干预。

方法

ENERGISED试验是一项务实的、为期12个月的多中心随机对照试验，评估由全科医生发起的移动健康干预措施，以增加2型糖尿病和糖尿病前期患者的身体活动并减少久坐行为。主要结局是通过佩戴在手腕上的加速度计评估的每日步数。主要分析遵循意向性分析原则，使用重复测量的混合模型。缺失数据将在随机缺失假设下进行处理，敏感性分析通过基于参考的多重插补探索稳健性。该试验采用估计量框架以提供透明且结构化的治疗效果估计。