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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-65
SponsorUniversity of Utah

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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 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

30 Participants
are divided into 1 treatment group
Group A: Waning Moon InterventionExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Intervention Appropriateness Measure (IAM)

Participant-reported acceptability of the Waning Moon intervention as measured by the Intervention Appropriateness Measure (IAM) scale.

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

Other outcomes

1

Intervention Fidelity

Counts and proportions of fidelity to Waning Moon session manuals as measured by a fidelity checklist completed by the study team.

Time frame
Each Waning Moon session (Weeks 1 through 4)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: