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Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women

24 augustus 2026 bijgewerkt door: Lisa J Taylor-Swanson, University of Utah
This study tests the feasibility and acceptability of Waning Moon, a culturally tailored menopause health intervention developed in partnership with the Urban Indian Center of Salt Lake (UICSL) for American Indian/Alaska Native (AI/AN) women. Waning Moon is a 4-session integrative medical group visit program delivered by community health workers and prescribing providers. It covers menopause education, complementary health approaches, and community support. Thirty midlife AI/AN women will participate. The study will assess whether the program is feasible to deliver and acceptable to participants and clinical partners.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Waning Moon
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.
Andere namen:
  • MENOGAP

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility - Feasibility of Intervention Measure (FIM) scale
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intervention Appropriateness Measure (IAM)
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intervention Fidelity
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Utah

Medewerkers

National Center for Complementary and Integrative Health (NCCIH)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

14 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juli 2026

Eerst geplaatst (Werkelijk)

20 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 1R34AT013448-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

The individual participant data and supporting information ill become available at the time of publication of primary study results, or by June 30, 2028 (the end of the NIH award project period), whichever occurs first. Once shared, data will remain available in the repository (The Hive, University of Utah) indefinitely, with no planned end date for access.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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