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NCT Number: NCT07713095

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

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.

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Key information

Conditions

Menopause American Indian or Alaska Native Health Disparities Vasomotor Symptoms (VMS) Women's Health

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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 CHWs and 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 UICSL (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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 UICSL in Salt Lake City, Utah English-speaking

Exclusion criteria

Currently enrolled in another menopause intervention study Do not identify as American Indian or Alaska Native Are not experiencing menopause

Treatment and study plan

Waning Moon

Behavioral

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 community health workers, 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: MENOGAP

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa J Associate Professor, College of Nursing, University of Utah

CONTACT

[email protected]

801-585-5486

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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