Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa J Associate Professor, College of Nursing, University of Utah
- Phone Number: 801-585-5486
- Email: lisa.taylor-swanson@nurs.utah.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Feasibility of Intervention Measure (FIM) scale
Time Frame: Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
|
Participant-reported feasibility of the Waning Moon intervention as measured by the Feasibility of Intervention Measure (FIM) scale.
|
Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Appropriateness Measure (IAM)
Time Frame: Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
|
Participant-reported acceptability of the Waning Moon intervention as measured by the Intervention Appropriateness Measure (IAM) scale.
|
Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Fidelity
Time Frame: Each Waning Moon session (Weeks 1 through 4)
|
Counts and proportions of fidelity to Waning Moon session manuals as measured by a fidelity checklist completed by the study team.
|
Each Waning Moon session (Weeks 1 through 4)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R34AT013448-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Sharing Time Frame
IPD Sharing Access Criteria
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 Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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