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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause; Women's Health; Health Disparities; Vasomotor Symptoms (VMS); American Indian or Alaska Native
• Intervention / Treatment: Behavioral: Waning Moon

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 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

• Study Type: Interventional
• Enrollment (Estimated): 30
• 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: No

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

Behavioral: 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Feasibility of Intervention Measure (FIM) scale	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)	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	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: University of Utah
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Menopause; Women's Health; Health Disparities; Vasomotor Symptoms; American Indian or Alaska Native
• Other Study ID Numbers: 1R34AT013448-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No