About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Currently enrolled in another menopause intervention study
Does not identify as American Indian or Alaska Native
Not experiencing menopause
Trial design
Single group
Treatments tested in this trial
Waning Moon
BehavioralWaning 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Intervention Appropriateness Measure (IAM)
Participant-reported acceptability of the Waning Moon intervention as measured by the Intervention Appropriateness Measure (IAM) scale.
Other outcomes
Intervention Fidelity
Counts and proportions of fidelity to Waning Moon session manuals as measured by a fidelity checklist completed by the study team.
Locations
Sponsors and contacts
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University of Utah
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
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