The Health, Aging, and Later-Life Outcomes Pilot Study: Design, recruitment, and participants' baseline characteristics

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-08-18 DOI:10.1016/j.cct.2025.108049

Cynthia L. Stowe , Kimberly Kennedy , Shannon S. Emilson , Rebecca H. Neiberg , Stephen B. Kritchevsky , Michael E. Miller , Denise K. Houston , Barbara J. Nicklas , Jason Fanning , W. Jack Rejeski , the HALLO-P Investigators

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引用次数: 0

Abstract

Background

Multi-morbidity increases significantly with age, and obesity is a major risk factor for conditions like cardiovascular disease and diabetes, indicating a critical need for effective interventions.

Objective

We discuss the study design of the HALLO-Pilot Study that randomized older adults to in-person caloric restriction (CR), remotely delivered CR (RCR), or a time restricted eating (TRE) intervention. In addition, we emphasize inclusion/exclusion criteria, recruitment, and baseline characteristics of randomized participants.

Methods

The study randomized 90 participants aged 60+ to one of three 9-month interventions. Eligibility focused on including adults with an indication for weight loss while excluding for safety concerns or factors potentially affecting adherence. Screening involved telephone interviews and in-person visits. Assessments included measures for eligibility, outcomes, adherence, and safety, with data collected at baseline, 6 months, and 9 months. The intervention involved in-person or online group meetings and individual contacts with participants monthly. Interventions included nutritional and behavioral guidance and a targeted increase in steps per day. Remote monitoring technology was used for monitoring diet and weight for CR participants and logging eating times for TRE participants.

Results

There were a total of 1753 pre-screening contacts with 678 (39 %) completing telephone screening. Of 139 (∼21 %) who were eligible after the telephone screening and consented, 135 participants attended in-person screening visits. Of those screened in-person, 90 were eligible and randomized for a yield of 13 %.

Conclusion

The HALLO-Pilot Study provided valuable insights into eligibility criteria and the recruitment of older adults for future large-scale trials of CR and TRE.

Clinical Trials.gov: NCT05424042.

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健康、老龄化和晚年结局试点研究：设计、招募和参与者基线特征

背景：随着年龄的增长，多种疾病的发病率显著增加，肥胖是心血管疾病和糖尿病等疾病的主要危险因素，这表明迫切需要采取有效的干预措施。目的：我们讨论了halo - pilot研究的研究设计，该研究将老年人随机分为现场热量限制（CR）、远程提供热量限制（RCR）或限时饮食（TRE）干预。此外，我们强调纳入/排除标准、招募和随机参与者的基线特征。方法本研究将90名60岁以上的参与者随机分为三组，每组为期9个月。资格的重点是纳入有减肥指征的成年人，而排除安全问题或可能影响依从性的因素。筛选包括电话采访和亲自访问。评估包括在基线、6个月和9个月收集的数据，包括适格性、结局、依从性和安全性。干预包括面对面或在线小组会议，以及每月与参与者进行个人接触。干预措施包括营养和行为指导以及每天有针对性地增加步数。采用远程监测技术监测CR参与者的饮食和体重，记录TRE参与者的进食时间。结果共筛查前接触者1753人，完成电话筛查者678人（39%）。在139名（约21%）接受电话筛查并同意的参与者中，135名参与者参加了现场筛查访问。在亲自筛选的人中，有90人符合条件，随机分组，成功率为13%。结论：halo - pilot研究为未来大规模CR和TRE试验的资格标准和老年人招募提供了有价值的见解。临床试验网站：NCT05424042。

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.