背景:建议定期进行体育锻炼(PA)以优化接受代谢和减肥手术(MBS)的患者的体重和健康结果。然而,>70%的患者在MBS之前具有低PA水平,在MBS之后持续存在。尽管面对面进行的行为干预已显示出增加MBS患者PA的希望,许多人可能会遇到障碍,防止注册和遵守此类干预措施。通过远程医疗向接受MBS的患者提供PA行为改变干预措施可能是增加可及性和覆盖范围的有效策略。以及坚持。
目的:本文报告了一项旨在评估方案或方法的可行性和可接受性以及远程健康减肥行为干预(TELE-BariACTIV)的研究方案。该干预措施旨在增加等待减肥手术的患者的中度至剧烈强度PA(MVPA),并以多理论方法和患者观点为指导。另一个目的是评估TELE-BariACTIV干预对术前MVPA的影响,以确定多中心试验的合适样本量。
方法:本研究是一项多中心试验,采用重复(ABAB\'A)单病例实验设计。A阶段是没有干预的观察阶段(A1=MBS前阶段;A2=根据MBS日期个性化的长度;A3=MBS后7个月)。B阶段是PA咨询的介入阶段(B1=MBS前每周6次;B2=MBS后3个月开始的每月3次)。目标样本大小设置为12。参与者是不活跃的成年人,等待袖状胃切除术,他们可以使用带有互联网的计算机和带有摄像头的接口。参与者被随机分配到1或2周的基线期(A1)。方案和干预的可行性和可接受性(主要结果)将通过记录缺失的数据来评估,拒绝,招募,保留,出席,和流失率,以及通过基于网络的可接受性问卷和半结构化访谈。将分析8次通过加速度计(7-14天)和10次通过问卷调查收集的数据,以评估干预对MVPA的影响。评估生活质量的概括措施,焦虑和抑郁症状,和基于理论的结构(即,PA的动机规定,自我效能,以克服障碍PA,基本的心理需求满足和沮丧,PA享受,和对PA的社会支持;未来大规模试验的次要结果)将通过6-10次基于网络的问卷完成。机构审查委员会于2021年6月为该研究提供了伦理批准。
结果:招募于2021年9月开始,所有参与者都参加了招募(n=12)。数据收集预计将于2023年秋季结束,具体取决于招募参与者的MBS日期。
结论:TELE-BariACTIV干预具有跨多个设置实施的潜力,因为它可以远程提供协作构建。
未经批准:DERR1-10.2196/39633。
BACKGROUND: Regular physical activity (PA) is recommended to optimize weight and health outcomes in patients who have undergone metabolic and bariatric surgery (MBS). However, >70% of patients have low PA levels before MBS that persist after MBS. Although behavioral interventions delivered face-to-face have shown promise for increasing PA among patients who have undergone MBS, many may experience barriers, preventing enrollment into and adherence to such interventions. Delivering PA behavior change interventions via telehealth to patients who have undergone MBS may be an effective strategy to increase accessibility and reach, as well as adherence.
OBJECTIVE: This paper
reports the protocol for a study that aims to assess the feasibility and acceptability of the protocol or methods and the Telehealth Bariatric Behavioral Intervention (TELE-BariACTIV). The intervention is designed to increase moderate-to-vigorous intensity PA (MVPA) in patients awaiting bariatric surgery and is guided by a multitheory approach and a patient perspective. Another objective is to estimate the effect of the TELE-BariACTIV intervention on presurgical MVPA to determine the appropriate sample size for a multicenter trial.
METHODS: This study is a multicenter trial using a repeated (ABAB\'A) single-
case experimental design. The A phases are observational phases without intervention (A1=pre-MBS phase; A2=length personalized according to the MBS date; A3=7 months post-MBS phase). The B phases are interventional phases with PA counseling (B1=6 weekly pre-MBS sessions; B2=3 monthly sessions starting 3 months after MBS). The target sample size is set to 12. Participants are inactive adults awaiting sleeve gastrectomy who have access to a computer with internet and an interface with a camera. The participants are randomly allocated to a 1- or 2-week baseline period (A1). Protocol and intervention feasibility and acceptability (primary outcomes) will be assessed by recording missing data, refusal, recruitment, retention, attendance, and attrition rates, as well as via web-based acceptability questionnaires and semistructured interviews. Data collected via accelerometry (7-14 days) on 8 occasions and via questionnaires on 10 occasions will be analyzed to estimate the effect of the intervention on MVPA. Generalization measures assessing the quality of life, anxiety and depressive symptoms, and theory-based constructs (ie, motivational regulations for PA, self-efficacy to overcome barriers to PA, basic psychological needs satisfaction and frustration, PA enjoyment, and social support for PA; secondary outcomes for a future large-scale trial) will be completed via web-based questionnaires on 6-10 occasions. The institutional review board provided ethics approval for the study in June 2021.
RESULTS: Recruitment began in September 2021, and all the participants were enrolled (n=12). Data collection is expected to end in fall 2023, depending on the MBS date of the recruited participants.
CONCLUSIONS: The TELE-BariACTIV intervention has the potential for implementation across multiple settings owing to its collaborative construction that can be offered remotely.
UNASSIGNED: DERR1-10.2196/39633.