背景:在成人2型糖尿病(T2D)中,减肥可以提高血红蛋白A1c,血压,和甘油三酯,并减少所需药物的频率。不幸的是,这些人中有很大一部分还没有准备好开始减肥,使现有的肥胖管理策略不太有效。许多数字健康干预措施旨在减肥,但是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T2D成人。
目的:本研究旨在开发和验证“Chance2Act,“一种新的基于网络的干预,专门设计用于促进尚未准备好减肥的T2D肥胖成年人的行为改变。然后,新开发的干预措施的有效性将从一项非随机对照试验中确定.
方法:将基于跨理论模型开发基于网络的干预措施,目标是尚未准备好减肥的T2D肥胖成年人。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2阶段,将在研究者选择的2个政府卫生诊所进行非随机对照试验。这是一项平行作业的非盲化研究(即,干预与控制[常规护理]的分配比例为1:1)。总共将招募124名研究参与者,其中62名参与者除了常规护理外,还将接受Chance2Act干预。主要结果是个人从没有准备好改变的阶段开始的准备程度的变化(预先考虑,沉思,或准备阶段)为减肥做好准备(行动阶段)。次要结果包括自我效能感的变化,决策平衡,家庭支持减肥,BMI,腰围,和身体脂肪成分。
结果:第一阶段研究将通过内容有效性指数和面部有效性指数揭示干预措施的有效性,如果两个指数都超过0.83,则认为有效。干预的有效性将在第2阶段确定,在该阶段,将根据方法中定义的变化阶段和所有次要结果的改善来分析组内和组间的差异。第二阶段的数据分析将于2024年开始,预计将于2024年3月公布结果。
结论:如果证明有效,这项研究的结果可能为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,该干预措施针对患有肥胖但尚未准备好改变体重的T2D成人.这种干预可以在不同的环境中复制或采用,专注于患者需要的行为矫正支持。这项研究提供了更深入的了解行为改变技术的应用,以更全面的方法在T2D中进行肥胖护理。
背景:ClinicalTrials.govNCT05736536;https://clinicaltrials.gov/study/NCT05736536。
■DERR1-10.2196/48313。
BACKGROUND: In adults with type 2 diabetes (T2D), weight loss can improve hemoglobin A1c, 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT05736536; https://clinicaltrials.gov/study/NCT05736536.
UNASSIGNED: DERR1-10.2196/48313.