Mohd Saad Noraini, Mohamad Mariam, Mat Ruzlin Aimi Nadira
Faculty of Medicine, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.
JMIR Res Protoc. 2024 Jan 31;13:e48313. doi: 10.2196/48313.
In adults with type 2 diabetes (T2D), weight loss can improve hemoglobin A, blood pressure, and triglycerides, and reduce the frequency of medications needed. Unfortunately, a large proportion of these individuals are not ready to initiate weight efforts, making existing obesity management strategies less effective. Many digital health interventions aim at weight loss, but there is still limited evidence on their effectiveness in changing weight loss behavior, especially in adults with T2D.
This study aims to develop and validate "Chance2Act," a new web-based intervention, designed specifically to facilitate behavioral change in adults with T2D with obesity who are not ready to act toward weight loss. Then, the effectiveness of the newly developed intervention will be determined from a nonrandomized controlled trial.
A web-based intervention will be developed based on the Transtheoretical Model targeting adults with T2D with obesity who are not ready to change for weight loss. Phase 1 will involve the development and validation of the web-based health intervention module. In phase 2, a nonrandomized controlled trial will be conducted in 2 government health clinics selected by the investigator. This is an unblinded study with a parallel assignment (ie, intervention vs control [usual care] with an allocation ratio of 1:1). A total of 124 study participants will be recruited, of which 62 participants will receive the Chance2Act intervention in addition to the usual care. The primary outcome is the changes in an individual's readiness from a stage of not being ready to change (precontemplation, contemplation, or preparation stage) to being ready for weight loss (action stage). The secondary outcomes include changes in self-efficacy, decisional balance, family support for weight loss, BMI, waist circumference, and body fat composition.
The phase 1 study will reveal the intervention's validity through the Content Validity Index and Face Validity Index, considering it valid if both indices exceed 0.83. The effectiveness of the intervention will be determined in phase 2, where the differences within and between groups will be analyzed in terms of the improvement of stages of change and all secondary outcomes as defined in the methodology. Data analysis for phase 2 will commence in 2024, with the anticipated publication of results in March 2024.
If proven effective, the result of the study may give valuable insights into the effective behavioral modification strategies for a web-based intervention targeting adults with T2D with obesity but not yet ready to change for weight loss. This intervention may be replicated or adopted in different settings, focusing on behavioral modification support that patients need. This study offers a deeper understanding of the application of behavior change techniques for a more holistic approach to obesity care in T2D.
ClinicalTrials.gov NCT05736536; https://clinicaltrials.gov/study/NCT05736536.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48313.
在2型糖尿病（T2D）成人患者中，体重减轻可改善糖化血红蛋白、血压和甘油三酯水平，并减少所需药物的使用频率。不幸的是，这些患者中很大一部分尚未准备好开始减肥行动，这使得现有的肥胖管理策略效果欠佳。许多数字健康干预措施旨在帮助减肥，但关于它们在改变减肥行为方面的有效性的证据仍然有限，尤其是在T2D成人患者中。
本研究旨在开发并验证“Chance2Act”，这是一种新的基于网络的干预措施，专门为尚未准备好采取减肥行动的肥胖T2D成人患者促进行为改变而设计。然后，通过非随机对照试验确定新开发干预措施的有效性。
将基于跨理论模型开发一种基于网络的干预措施，针对尚未准备好为减肥而改变的肥胖T2D成人患者。第一阶段将涉及基于网络的健康干预模块的开发和验证。在第二阶段，将在研究者选择的两家政府健康诊所进行非随机对照试验。这是一项非盲研究，采用平行分组（即干预组与对照组[常规护理]，分配比例为1:1）。总共将招募124名研究参与者，其中62名参与者除接受常规护理外，还将接受Chance2Act干预。主要结局是个体从尚未准备好改变的阶段（前 contemplation阶段、 contemplation阶段或准备阶段）转变为准备好减肥的阶段（行动阶段）的意愿变化。次要结局包括自我效能感、决策平衡、家庭对减肥的支持、体重指数、腰围和身体脂肪组成的变化。
第一阶段研究将通过内容效度指数和表面效度指数揭示干预措施的有效性，如果两个指数均超过0.83，则认为该干预措施有效。干预措施的有效性将在第二阶段确定，届时将根据方法中定义的改变阶段和所有次要结局的改善情况分析组内和组间差异。第二阶段的数据分析将于2024年开始，预计结果将于2024年3月发表。
如果被证明有效，该研究结果可能为针对尚未准备好为减肥而改变的肥胖T2D成人患者的基于网络的干预措施的有效行为改变策略提供有价值的见解。这种干预措施可能在不同环境中得到复制或采用，重点是患者所需的行为改变支持。本研究为在T2D中采用更全面的肥胖护理方法应用行为改变技术提供了更深入的理解。
ClinicalTrials.gov NCT05736536；https://clinicaltrials.gov/study/NCT05736536。
国际注册报告识别码（IRRID）：DERR1-10.2196/48313。
