Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
研究概览
详细说明
1 OBJECTIVES The purpose of this study is to evaluate the feasibility and acceptability of Waning Moon to inform future clinical trials. Our objectives are to 1) engage AI/AN partners to further co-develop the intervention protocols and training processes for licensed or prescribing providers 2) assess the feasibility and acceptability of Waning Moon. The data gathered will inform a future multisite efficacy study of the intervention. This work is supported by preliminary data from our co-development of Waning Moon.
1.1 Overall Study Methods This R34 will support a three-year project (Figure 4) to establish new relationships with AI/AN communities while strengthening our established 3-year relationship with Urban Indian Center of Salt Lake City (Letter of Support) and feasibility testing the Waning Moon intervention. Once all approvals are in place, we will develop a Leadership Advisory Board (LAB) comprised of UICSL clinical and community AI/AN leaders or members of the Utah Indian Health Advisory Board (UIHAB, Letter of Support); to recruit additional Community Advisory Board (CAB) members. Several prior CAB members wish to continue their engagement (Letter of Support). Should Waning Moon be deemed feasible and acceptable in the presently proposed study, the research team in collaboration with the Boards will design a subsequent multisite feasibility study in alignment with the NCCIH Research Framework.2
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Lisa J Associate Professor, College of Nursing, University of Utah
- 电话号码：801-585-5486
- 邮箱：lisa.taylor-swanson@nurs.utah.edu
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Self-identifies as American Indian or Alaska Native
- Female, age 35-65
- Experiencing menopause-related symptoms (e.g., vasomotor symptoms)
- Able to attend sessions at Urban Indian Center of Salt Lake in Salt Lake City, Utah
- English-speaking
Exclusion Criteria:
- Currently enrolled in another menopause intervention study
- Does not identify as American Indian or Alaska Native
- Not experiencing menopause
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Waning Moon Intervention
Four-session integrative medical group visit program delivered by community health workers with prescribing provider involvement.
Sessions cover menopause education, complementary health approaches including acupressure, mindfulness, and herbal supplements, and facilitated community discussion.
Participants also complete a follow-up visit at 12 weeks.
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Waning Moon is a culturally tailored integrative medical group visit program developed by and for urban American Indian/Alaska Native women experiencing menopause.
The program consists of four weekly 90-minute group sessions delivered by trained licensed and/or prescribing providers, with involvement from prescribing providers.
Sessions integrate conventional and complementary menopause education, experiential practices (mindfulness, self-acupressure), and facilitated group discussion.
Topics include vasomotor symptoms, insomnia, stress, pain, inflammation, cardiovascular health, and goal setting.
Participants are referred to onsite prescribing providers for clinical evaluation and management as indicated.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility - Feasibility of Intervention Measure (FIM) scale
大体时间：Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
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Participant-reported feasibility of the Waning Moon intervention as measured by the Feasibility of Intervention Measure (FIM) scale.
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Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intervention Appropriateness Measure (IAM)
大体时间：Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
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Participant-reported acceptability of the Waning Moon intervention as measured by the Intervention Appropriateness Measure (IAM) scale.
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Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intervention Fidelity
大体时间：Each Waning Moon session (Weeks 1 through 4)
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Counts and proportions of fidelity to Waning Moon session manuals as measured by a fidelity checklist completed by the study team.
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Each Waning Moon session (Weeks 1 through 4)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 1R34AT013448-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Plan Description:
De-identified individual participant data will be archived in The Hive, a University of Utah research data repository maintained by the Marriott Library. Data will be shared no later than the time of publication or the end of the project period, whichever occurs first, and will remain available in the repository permanently. Each dataset will receive a Digital Object Identifier (DOI) to link the data to resulting publications. All data will be stripped of identifiers prior to sharing, consistent with participant consent and University of Utah and NIH data sharing policies.
Access Criteria:
De-identified data will be made publicly available in The Hive under a Creative Commons Attribution-NonCommercial license (CC BY-NC 4.0), which permits use with attribution to the data creators and prohibits commercial use. Data elements determined to carry a risk of indirect or deductive identification (e.g., geospatial indicators below the state level) will instead be provided as
IPD 共享时间框架
IPD 共享访问标准
Who: Any qualified researcher may access de-identified data made publicly available in the repository. Researchers seeking restricted-access data elements (those carrying a risk of indirect or deductive identification) must demonstrate a valid research need and agree to conditions of use under a data use contract.
What: De-identified individual participant data, along with the Study Protocol and Informed Consent Form, will be accessible. Data determined to carry re-identification risk (e.g., geospatial indicators below the state level) will be withheld from public access and offered only under restricted-access terms.
How: Data will be archived in The Hive, a University of Utah research data repository maintained by the Marriott Library, under a Creative Commons Attribution-NonCommercial license (CC BY-NC 4.0), which requires attribution to the data creators and prohibits commercial use. Each dataset will receive a Digital Object Identifier (DOI) linking it to resulting publications.
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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