American Indian or Alaska Native, Health Disparities, Menopause, Vasomotor Symptoms (VMS), Women's Health
Conditions
Keywords
Menopause, Vasomotor Symptoms, Women's Health, American Indian or Alaska Native, Health Disparities
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.
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 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
Interventions
BEHAVIORALWaning 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.
Sponsors
University of Utah
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Feasibility of Intervention Measure (FIM) scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Intervention Appropriateness Measure (IAM) | 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. |
Contacts
CONTACTLisa J Associate Professor, College of Nursing, University of Utah
Outcome results
None listed