Preference for behavior change strategies in randomized controlled trials: Evidence from weight management

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-07-28 DOI:10.1016/j.cct.2025.108031

Michael Sobolev , Julissa Ruiz , Márcio A. Diniz , Hollie Raynor , Gary D. Foster , Aaron R. Seitz , Sarah-Jeanne Salvy

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引用次数: 0

Abstract

Background

Randomized controlled trial participants are expected to embrace assignment to any of the study arms, yet individuals' relative preference for the study arms invariably affects who participates in trials and for how long.

Methods

Our ongoing Avoid/Resist trial (1R01DK130851) tests two strategies to bridge the intention-behavior gap in a weight management intervention. Avoid combines pantry makeover and online grocery shopping. Resist involves gamified, inhibitory control training. During screening, individuals rate Avoid and Resist on affective valence (I don't like this – I like this) and instrumental utility (This will not benefit me – This will benefit me) using a 0–100 analogue scale. K-means clustering was used to identify clusters of individuals based on their liking and perceived benefits of the tested strategies before randomization.

Results

Among respondents who completed the screener between January 2024 and January 2025 (n = 306; 64 % Female; 40 % Hispanic/Latino), the correlations between liking and perceived benefit ratings were high (>0.70). Median scores of liking and perceived benefits were 90 and 88 for Resist, and 91.5 and 90 for Avoid. K-means clustering revealed 3 groups: (1) highly favorable to Avoid and Resist (all ratings >90; 61 %); (2) relative preference for Resist (22 %); (3) relative preference for Avoid (17 %).

Conclusions

Even among individuals willing to be randomized, nearly 40 % had a relative preference for one of the study arms. Additional work is needed to understand the role of relative preference on retention, adherence, and outcomes in weight management trials.

Trial registration: The study is registered with ClinicalTrials.gov (NCT05143931).

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随机对照试验中行为改变策略的偏好：来自体重管理的证据

期望随机对照试验参与者接受分配到任何研究组，然而个体对研究组的相对偏好总是影响谁参加试验以及参加多长时间。方法一项正在进行的避免/抵抗试验（1R01DK130851）测试了两种策略来弥合体重管理干预中的意向-行为差距。避免将食品储藏室改造和网上购物结合起来。抵抗包括游戏化、抑制性控制训练。在筛选过程中，个人使用0-100的模拟量表对情感效价（我不喜欢这个-我喜欢这个）和工具效用（这对我没有好处-这对我有益）进行避免和抵抗评分。在随机化之前，使用K-means聚类来识别基于他们对测试策略的喜好和感知收益的个体聚类。结果在2024年1月至2025年1月完成筛查的受访者中(n = 306；女性占64%；40%的西班牙裔/拉丁裔)，喜欢和感知利益评级之间的相关性很高（>0.70）。“抵制”的喜欢度和感知利益的中值分别为90分和88分，“避免”的中值分别为91.5分和90分。K-means聚类揭示了3个群体：(1)对Avoid和Resist非常有利(所有评分>90；61%);(2)抗药的相对偏好（22%）；(3)对Avoid的相对偏好（17%）。在愿意被随机分配的个体中，近40%的人相对偏好其中一种研究组。在体重管理试验中，需要进一步的工作来了解相对偏好对保留、坚持和结果的作用。试验注册：该研究已在ClinicalTrials.gov注册（NCT05143931）。

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.