一项开发生物行为适应性干预以改善1期肥胖患者胰岛素敏感性的先导序贯多任务随机试验。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Aseel El Zein, Katie M Ellison, Julianne G Clina, Chelsi Reynolds, Caroline W Cohen, James O Hill, Gareth R Dutton, Tapan S Mehta, R Drew Sayer
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引用次数: 0

摘要

背景:针对肥胖相关疾病的干预方案通常包括多种行为和药理学成分,但这些策略对疾病进展的独立和协同作用在很大程度上仍未被探索。适应性干预提供了一种基于个体反应的结构化方法来定制治疗,但初级保健机构的可行性数据有限。本先导性顺序多任务随机试验(SMART)的目的是研究一种为期25周的适应性生物行为干预的可行性,该干预旨在改善1期肥胖患者的胰岛素敏感性。方法:40名参与者最初被随机分配到营养咨询(NC)或运动咨询(EC),两者都采用体重中立的方法。第8周,使用定量胰岛素敏感性检查指数(QUICKI)重新评估胰岛素敏感性。改善0.5 %的参与者被归类为有反应者,而无反应者被重新随机分组,要么用二甲双胍增加第一阶段干预,要么改用减肥咨询(WLC)。可行性结果包括招募和保留、干预成分的依从性和初步治疗效果评估。结果:研究结果支持SMART设计的总体可行性,具有高依从性的虚拟咨询会议和良好的参与者保留。该研究在第8周有效地区分了应答者和无应答者,应答者表现出更大的胰岛素敏感性改善。在无应答者中,WLC和二甲双胍提供了潜在的挽救作用,但总体胰岛素敏感性仍低于应答者。虽然NC和WLC比EC和二甲双胍更受欢迎,但在所有干预措施中,无论偏好如何,咨询会议的依从性仍然很高。二甲双胍的依从性由于频繁的胃肠道副作用和难以追踪使用情况而面临挑战。结论:本初步研究支持适应性生物行为干预在初级保健环境中改善成人肥胖患者胰岛素敏感性的可行性。然而,需要进一步完善,加强临床整合,优化干预信息,改善药物跟踪。这项研究的结果将为第二个SMART试点提供信息,为全面的初级保健嵌入式干预奠定基础,为改善心脏代谢健康提供个性化的适应性策略。试验报名:NCT04392283, 2020年4月19日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity.

A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity.

A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity.

A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity.

Background: Intervention packages targeting obesity-related conditions often include multiple behavioral and pharmacological components, yet the independent and synergistic effects of these strategies on disease progression remain largely unexplored. Adaptive interventions offer a structured approach to tailoring treatments based on individual responses, but feasibility data in primary care settings are limited. The objective of this pilot Sequential Multiple Assignment Randomized Trial (SMART) was to investigate the feasibility of a 25-week adaptive biobehavioral intervention designed to improve insulin sensitivity among patients with stage 1 obesity.

Methods: Forty participants were initially randomized to either nutrition counseling (NC) or exercise counseling (EC), both employing a weight-neutral approach. At week 8, insulin sensitivity was reassessed using the Quantitative Insulin Sensitivity Check Index (QUICKI). Participants with a > 5% improvement were classified as responders, while non-responders were re-randomized to either augment their first-stage intervention with metformin or switch to weight loss counseling (WLC). Feasibility outcomes included recruitment and retention, adherence to intervention components, and preliminary treatment effect estimates.

Results: Findings support the overall feasibility of the SMART design, with high adherence to virtual counseling sessions and favorable participant retention. The study effectively differentiated responders from non-responders at week 8, with responders showing greater improvements in insulin sensitivity. Among non-responders, WLC and metformin provided a potential rescue effect, but overall insulin sensitivity remained lower than at of responders. While NC and WLC were preferred over EC and metformin, adherence to counseling sessions remained high across all interventions, regardless of preference. Metformin adherence posed challenges due to frequent gastrointestinal side effects and difficulties tracking usage.

Conclusions: This pilot study supports the feasibility of an adaptive biobehavioral intervention for improving insulin sensitivity among adults with obesity in a primary care setting. However, further refinement is needed to enhance clinical integration, optimize intervention messaging, and improve medication tracking. Findings from this study will inform a second pilot SMART, laying the foundation for a full-scale primary-care embedded intervention delivering personalized, adaptive strategies for improving cardiometabolic health.

Trial registration: NCT04392283 on April 19th, 2020.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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