Development of a lifestyle physical activity intervention to reduce risk for perinatal cannabis use

制定生活方式体育活动干预措施以降低围产期大麻使用风险

基本信息

批准号：
10665268
负责人：
CYNTHIA L. BATTLE
金额：
$ 14.45万
依托单位：
BUTLER HOSPITAL (PROVIDENCE, RI)
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10665268
关键词：
Accelerometer Acute Address Administrative Supplement Affect Anxiety Award Behavior Cannabis Clinical Trials Coping Skills Counseling Data Data Collection Development Distress Drug usage Ecological momentary assessment Enrollment Financial compensation Funding Future Incentives Intervention Intervention Studies Life Style Long-Term Effects Measures Medical Mental Depression Mental Health Modeling Motivation Nature Nausea Participant Physical activity Population Pregnancy Pregnant Women Protocols documentation Randomized Controlled Trials Recommendation Reporting Research Risk Role Sampling Schedule Series Symptoms Telephone Woman Work active method adverse maternal outcomes base comparison group craving design exercise intervention experience fitbit infant outcome marijuana use marijuana use in pregnancy negative affect perinatal cannabis use personalized approach physical symptom pregnant prevent randomized trial recruit response stem therapy design therapy development

项目摘要

ABSTRACT Rates of prenatal cannabis use (CU) have risen sharply in recent years, a serioius concern given associated adverse maternal and infant outcomes. Motivation to change potentially unhealthy behaviors like CU is high among many pregnant women. However, unfortunately, intervention approaches for this population are currently lacking. In addition, many women experience mental health symptoms (anxiety, depression) and uncomfortable pregnancy symptoms (nausea, physical discomfort) that pose challenges to abstaining from CU. Thus, interventions that help pregnant women develop alternate coping strategies to cope with these symptoms may have an important role in decreasing or preventing CU during pregnancy and longer term. Given prior research demonstrating benefits of physical activity to potentiate long-term effects on depression/anxiety and pregnancy symptoms, as well as acute effects on negative affect and cannabis cravings, a lifestyle physical activity (LPA) intervention could be highly impactful. Our team’s R34 award (R34DA055317-01A1; Battle) is the first study to examine whether an LPA intervention could represent a feasible and acceptable strategy to help reduce cannabis use and cravings during pregnancy. The proposed administrative supplement would allow our team to extend the impact of this R34 study by examining the potential mechanisms of action of the LPA intervention. Our team proposes to use supplemental funding in response to NOT-OD-22-140 to add an ecological momentary assessment (EMA) protocol to the planned clinical trial, which would be comprised of three 7-day bursts of daily EMA assessment to measure daily-level physical activity, maternal affect, physical discomfort, as well as cannabis cravings and use. With this additional data collection, which will include 30 participants in the pilot randomized trial, we will be able to more fully evaluate the conceptual model on which the study intervention is based. Findings from the analysis of the additional EMA data collected as part of this supplement will provide valuable information regarding the relationship between women’s mental health and cannabis cravings -- and whether physical activity can help reduce negative affect, physical discomforts and cannabis cravings. In addition, this supplemental data will provide critical feasibility data regarding implementing an EMA with this population to inform future studies.

抽象的近年来，产前大麻使用率 (CU) 急剧上升，这是一个严重的问题，因为相关改变 CU 等潜在不健康行为的动机很高。然而，不幸的是，针对这一人群的干预方法还很有限。此外，许多女性还存在心理健康症状（焦虑、抑郁）和不舒服的妊娠症状（恶心、身体不适）对戒断 CU 构成挑战。因此，帮助孕妇制定替代应对策略来应对这些问题的干预措施症状可能对减少或预防怀孕期间及长期的 CU 具有重要作用。鉴于先前的研究表明体力活动可以增强对身体的长期影响抑郁/焦虑和怀孕症状，以及对负面情绪和大麻的急性影响生活方式体育活动 (LPA) 干预可能会产生巨大影响。（R34DA055317-01A1；Battle）是第一项研究 LPA 干预是否可以代表可行且可接受的策略，以帮助减少怀孕期间的大麻使用和渴望。行政补充将使我们的团队能够通过检查 R34 研究的影响来扩大 R34 研究的影响 LPA 干预的潜在行动机制我们的团队建议使用补充资金。响应 NOT-OD-22-140，在计划中添加生态瞬时评估 (EMA) 协议临床试验，其中包括三个为期 7 天的每日 EMA 评估，以测量每日水平体力活动、产妇影响、身体不适以及对大麻的渴望和使用。额外的数据收集，其中将包括 30 名随机试验参与者，我们将能够更多全面评估研究干预所依据的概念模型。作为本补充的一部分收集的其他 EMA 数据将提供有关女性心理健康与大麻渴望之间的关系——以及体力活动是否有帮助此外，这些补充数据将减少负面影响、身体不适和大麻渴望。提供有关对该人群实施 EMA 的关键可行性数据，为未来的研究提供信息。