为产后抑郁高风险人群量身定制的产后电子健康体育活动干预--产后健康研究(POW):随机对照试验的方案和数据概述。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2024-10-29 DOI:10.2196/56882
Maya Ramsey, Nina Oberman, Charles P Quesenberry, Elaine Kurtovich, Lizeth Gomez Chavez, Aaloni Chess, Susan Denise Brown, Cheryl L Albright, Mibhali Bhalala, Sylvia E Badon, Lyndsay A Avalos
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引用次数: 0

摘要

背景:产后抑郁症(PPD)会对父母和孩子的健康造成严重影响。目前预防产后抑郁症的建议需要大量的医疗保健系统资源。我们需要以证据为基础的干预措施来预防产后抑郁症,同时又不会进一步加重医疗保健系统的负担。有证据表明,体育活动(PA)通常可以减轻抑郁症状。基于技术的干预措施可能有助于减少体育锻炼的常见障碍:本研究旨在报告 "产后健康研究"(POstpartum Wellness study,POW)的方案并提供数据概览。该研究是一项有效性试验,旨在评估为产后人群量身定制的电子健康 PA 干预是否能增加 PA 并减轻 PPD 高危人群的抑郁症状:这项远程平行分组随机对照试验的参与者包括有抑郁症病史或目前至少有中度抑郁症状但未达到 PPD 诊断标准且 PA 水平较低的产后人士,他们来自一个综合医疗保健服务系统。参与者被随机分配到电子健康 PA 干预组或常规护理组。干预组可以访问专为产后人士设计的网络锻炼视频库,其中包括与婴儿的互动。在基线和随访(3 个月和 6 个月)期间,使用调查问卷和腕戴式加速度计对 PA 进行测量。抑郁症状采用患者健康问卷-8(PHQ-8)进行测量。收集的数据用于评估睡眠、感知压力、焦虑、亲子关系和婴儿发育等探索性结果:该研究于 2020 年 1 月获得资助。参与者在 2020 年 11 月至 2022 年 9 月期间通过 REDCap(研究电子数据采集)或电话报名;数据收集于 2023 年 4 月结束。随机参与者(N=99)基线为产后 4 个月,有中度严重抑郁症状(PHQ-8 平均得分为 12.6,SD 为 2.2)。干预组(人数=50)和常规护理组(人数=49)的社会人口特征、产后月数、基线抑郁症状、家中孩子数量和孕前 PA 水平相似。问卷调查的保留率≥66%,加速度测量的保留率≥48%,各组之间差异不大。在 3 个月的随访中,99 名参与者中有 73 人(74%)完成了问卷调查(干预组:35/50,70%;常规护理组:38/49,78%);99 人中有 53 人(54%)佩戴了 7 天的加速度计(干预组:50 人中有 27 人(54%);常规护理组:49 人中有 26 人(53%))。在为期 6 个月的随访中,99 名参与者中有 66 名(67%)完成了问卷调查(50 名参与者中有 30 名(60%)接受了干预,49 名参与者中有 36 名(73%)接受了常规护理),99 名参与者中有 43 名(43%)连续 7 天佩戴加速度计(50 名参与者中有 21 名(42%)接受了干预,49 名参与者中有 22 名(45%)接受了常规护理)。数据分析已经完成,包含这些研究结果的手稿目前正在审核出版中:POW 试验评估了电子健康 PA 干预对改善抑郁症状和增加 PPD 高危产后人群 PA 的有效性。试验结果对弱势患者行为干预措施的设计和实施具有指导意义:ClinicalTrials.gov NCT04414696; https://clinicaltrials.gov/ct2/show/NCT04414696.International 注册报告标识符 (irrid):DERR1-10.2196/56882。
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A Tailored Postpartum eHealth Physical Activity Intervention for Individuals at High Risk of Postpartum Depression-the POstpartum Wellness Study (POW): Protocol and Data Overview for a Randomized Controlled Trial.

Background: Postpartum depression (PPD) is associated with significant health consequences for the parent and child. Current recommendations for PPD prevention require intense health care system resources. Evidence-based interventions for PPD prevention that do not further burden the health care system are needed. Evidence suggests that physical activity (PA) can generally reduce depressive symptoms. Technology-based interventions may help decrease common barriers to PA.

Objective: This study aims to report the protocol and provide a data overview of the POstpartum Wellness study (POW)-an effectiveness trial evaluating whether an eHealth PA intervention tailored for postpartum individuals increased PA and decreased depressive symptoms among individuals at high PPD risk.

Methods: This remote parallel-group randomized controlled trial included postpartum individuals with a history of depression or at least moderate current depressive symptoms not meeting the PPD diagnostic threshold and with low PA levels from an integrated health care delivery system. Participants were randomized to an eHealth PA intervention or usual care. The intervention group received access to a library of web-based workout videos designed for postpartum individuals, which included interaction with their infants. At baseline and follow-up (3 and 6 months), PA was measured using questionnaires and a wrist-worn accelerometer. Depressive symptoms were measured using the Patient Health Questionnaire-8 (PHQ-8). Data were collected to assess exploratory outcomes of sleep, perceived stress, anxiety, parent-infant bonding, and infant development.

Results: The study was funded in January 2020. Participants were enrolled via REDCap (Research Electronic Data Capture) or telephonically between November 2020 and September 2022; data collection ended in April 2023. Randomized participants (N=99) were 4 months post partum at baseline with moderately severe depressive symptoms (mean PHQ-8 score 12.6, SD 2.2). Intervention (n=50) and usual care (n=49) groups had similar sociodemographic characteristics, months post partum, baseline depressive symptoms, number of children at home, and prepregnancy PA levels. Retention in assessments was ≥66% for questionnaires and ≥48% for accelerometry, with modest differences by group. At 3-month follow-up, 73 of 99 (74%) participants (intervention: 35/50, 70%; usual care: 38/49, 78%) completed questionnaires; 53 of 99 (54%) wore the accelerometer for 7 days (27 of 50 (54%) intervention, 26 of 49 (53%) usual care). At 6-month follow-up, 66 of 99 (67%) participants (30 of 50 (60%) intervention, 36 of 49 (73%) usual care) completed questionnaires and 43 of 99 (43%) wore the accelerometer for 7 days (21 of 50 (42%) intervention, 22 of 49 (45%) usual care). Data analysis is completed, and a manuscript with these findings is currently under review for publication.

Conclusions: The POW trial evaluates the effectiveness of an eHealth PA intervention for improving depressive symptoms and increasing PA among postpartum individuals at high PPD risk. Results have implications for the design and delivery of behavioral interventions among vulnerable patients.

Trial registration: ClinicalTrials.gov NCT04414696; https://clinicaltrials.gov/ct2/show/NCT04414696.

International registered report identifier (irrid): DERR1-10.2196/56882.

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