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针对肥胖成年人的身体活动自我效能在线干预:一项可行性研究方案

Physical activity self-efficacy online intervention for adults with obesity: protocol for a feasibility study.

作者信息

Lee Seungmin, Lahoda Kevin, Myers Nicholas D, Horowitz Andrew, Chiu Kenneth, Begdache Lina, Einav Eldad

机构信息

Division of Health and Wellness Studies, Binghamton University, Binghamton, USA.

Department of Art, Architecture and Design, Lehigh University, Bethlehem, USA.

出版信息

Pilot Feasibility Stud. 2024 Feb 26;10(1):40. doi: 10.1186/s40814-024-01468-6.

Abstract

BACKGROUND

Even without weight loss, adults with obesity can greatly benefit from regular physical activity. The Physical Activity Self-efficacy (PAS) intervention is an online behavioral intervention newly developed to promote physical activity in adults with obesity by providing capability-enhancing learning opportunities. The objective of this manuscript is to describe the protocol for a feasibility study designed to investigate the feasibility and acceptability of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the United States of America (USA).

METHODS

The study design is a prospective, double-blind, parallel-group individual randomized pilot trial. Thirty participants will be randomly assigned to the PAS group or usual care group to achieve a 1:1 group assignment. Recruitment of participants is scheduled to begin on 1 March 2024 at a local weight management center within a private healthcare system in the USA. There are six eligibility criteria for participation in this study (e.g., a body mass index ≥ 25.00 kg/m). Eligibility verification and data collection will be conducted online. Three waves of data collection will take up to 14 weeks depending on participants' progress in the study. The primary feasibility outcomes in the study will be: (a) participation rate, (b) engagement behavior, and (c) a preliminary effect size estimate for the effect of the PAS intervention on physical activity. Instruments designed to measure demographic information, anthropometric characteristics, self-efficacy, and acceptability will be included in the survey battery. A research-grade accelerometer will be used to measure free-living physical activity objectively. Data will be analyzed using descriptive statistics and inferential statistical models under an intention-to-treat approach.

DISCUSSION

Results are intended to inform the preparation of a future definitive randomized controlled trial.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT05935111, registered 7 July 2023.

摘要

背景

即使没有体重减轻,肥胖成年人也能从定期体育活动中受益匪浅。体育活动自我效能感(PAS)干预是一种新开发的在线行为干预措施,旨在通过提供增强能力的学习机会,促进肥胖成年人的体育活动。本手稿的目的是描述一项可行性研究的方案,该研究旨在调查对从美国当地体重管理中心招募的肥胖成年人实施PAS在线干预的可行性和可接受性。

方法

本研究设计为前瞻性、双盲、平行组个体随机试点试验。30名参与者将被随机分配到PAS组或常规护理组,以实现1:1的分组。参与者招募计划于2024年3月1日在美国一家私人医疗系统内的当地体重管理中心开始。参与本研究有六项资格标准(例如,体重指数≥25.00kg/m)。资格验证和数据收集将在线进行。根据参与者在研究中的进展情况,三轮数据收集将持续长达14周。该研究的主要可行性结果将是:(a)参与率,(b)参与行为,以及(c)PAS干预对体育活动影响的初步效应量估计。调查问卷中将包括用于测量人口统计学信息、人体测量特征、自我效能感和可接受性的工具。将使用研究级加速度计客观地测量自由生活中的体育活动。数据将采用意向性分析方法,使用描述性统计和推断性统计模型进行分析。

讨论

研究结果旨在为未来确定性随机对照试验的准备工作提供参考。

试验注册

ClinicalTrials.gov,NCT05935111,于2023年7月7日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a133/10895849/7b7589df5cbb/40814_2024_1468_Fig1_HTML.jpg

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