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

• 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
• 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

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.

摘要 近年来，产前大麻使用率急剧上升，这是一个严重的问题， 不利的母婴后果。改变潜在的不健康行为（如CU）的动机很高 很多孕妇。然而，不幸的是，针对这一人群的干预措施 目前缺乏。此外，许多妇女经历心理健康症状（焦虑，抑郁）， 不舒服的怀孕症状（恶心，身体不适）对放弃CU构成挑战。 因此，帮助孕妇制定替代应对策略来科普这些问题的干预措施， 症状可能在减少或预防CU在怀孕期间和长期的重要作用。 鉴于先前的研究表明，体力活动的好处，以加强长期的影响， 抑郁/焦虑和怀孕症状，以及对负面情绪和大麻的急性影响 渴望，生活方式的身体活动（LPA）干预可能是非常有效的。我们团队的R34奖 （R34 DA 055317 - 01 A1; Battle）是第一项检查LPA干预是否代表 这是一项可行和可接受的战略，有助于减少怀孕期间的大麻使用和渴望。拟议 行政补充将允许我们的团队通过检查 LPA干预的潜在作用机制。我们的团队建议将补充资金用于 对NOT-OD-22-140的响应，在计划的 临床试验，包括三次为期7天的每日EMA评估，以测量每日水平 身体活动，母亲的影响，身体不适，以及大麻的渴望和使用。与此 额外的数据收集将包括试点随机试验的30名参与者，我们将能够获得更多数据 充分评价研究干预措施所基于的概念模型。分析的结果 作为本补充资料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 减少负面影响，身体不适和对大麻的渴望。此外，该补充数据将 提供关于在该人群中实施EMA的关键可行性数据，以告知未来的研究。