Design of the SHARE study: A randomized controlled trial evaluating the regulation of cues treatment for adults with overweight or obesity and high food responsiveness

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-06-01 DOI:10.1016/j.cct.2025.107970

Kerri N. Boutelle , Dawn M. Eichen , Saori Obayashi , Ellen K. Pasquale , David R. Strong , Allison S. Tietz , Kristie L. Reed , Carol B. Peterson

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Abstract

Obesity is a heterogeneous disease influenced by individual behavioral factors, environment, genes, and neural processes. Behavioral weight loss (BWL), the current gold-standard treatment for overweight and obesity (OW/OB), does not produce sustained weight loss for all individuals. Appetitive traits, such as food responsiveness (FR), are risk factors that could account for differences in how individuals interact with today's food environment and increase susceptibility for overeating and weight gain. Research shows that individuals high in FR have attenuated weight loss in BWL programs. We developed the Regulation of Cues (ROC) program to reduce overeating through improving sensitivity to hunger and satiety cues and decreasing FR. In this study, we combined ROC with BWL recommendations (ROC+BWL), a treatment approach that may address the unique needs of this phenotype. The current study is a 3-arm randomized controlled trial comparing the ROC+BWL program to BWL and an active comparator on body mass index. Two hundred ninety-three adults with high FR and OW/OB were randomized to 1 of 3 treatment arms and will complete 6 months of treatment and assessment visits over 18 months: baseline, during treatment, post-treatment (6 months), 6-month follow-up (12 months) and 12-month follow-up (18 months). This study could provide important evidence regarding the ROC+BWL program among individuals with high FR and OW/OB and may inform future precision medicine approaches for OW/OB.

Clinical trials # NCT05004883

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SHARE研究的设计：一项随机对照试验，评估线索治疗对超重或肥胖和高食物反应性成人的调节作用。

肥胖是一种异质性疾病，受个体行为因素、环境、基因和神经过程的影响。行为减肥（BWL）是目前治疗超重和肥胖（OW/OB）的黄金标准，并不是所有人都能持续减肥。食欲特征，如食物反应（FR），是可以解释个体如何与当今食物环境相互作用的差异的风险因素，并增加了暴饮暴食和体重增加的易感性。研究表明，FR高的个体在BWL项目中体重减轻的效果较弱。我们制定了线索调节（ROC）计划，通过提高对食欲线索的敏感性和降低FR来减少暴饮暴食。在本研究中，我们将ROC与BWL建议（ROC+BWL）结合起来，这是一种可能解决该表型独特需求的治疗方法。目前的研究是一项三组随机对照试验，比较ROC+BWL方案与BWL和身体质量指数的有效比较。233名患有高FR和OW/OB的成年人被随机分配到3个治疗组中的1个，并将完成6个 月的治疗和18个 月的评估访问：基线、治疗期间、治疗后（6 月）、6个月的随访（12 月）和12个月的随访（18 月）。本研究可以为高FR和OW/OB患者的ROC+BWL方案提供重要证据，并可能为未来OW/OB的精准医学方法提供信息。临床试验# NCT05004883。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.