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

NCT07713095 | Not Yet Recruiting

• 1 other identifier: 1R34AT013448-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Menopause; Vasomotor Symptoms; Women's Health; American Indian or Alaska Native; Health Disparities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intervention Appropriateness Measure (IAM)

  Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)

Other Outcomes (1)

• Intervention Fidelity

  Each Waning Moon session (Weeks 1 through 4)

Study Arms (1)

Waning Moon Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: MENOGAP

Waning Moon Intervention

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Central Study Contacts

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

CONTACT

801-585-5486; lisa.taylor-swanson@nurs.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Principal Investigator

Model Details: Four-session integrative medical group visit program covering menopause education, complementary health approaches (acupressure, mindfulness, yoga, herbal supplements), and community support. Delivered by a prescribing provider.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-04