MenopauseNCT07713095
Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
A study testing Waning Moon in people with Menopause and Vasomotor Symptoms (VMS), run by University of Utah.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Menopause, Vasomotor Symptoms (VMS), Women's Health
- What is being tested?
- Waning Moon
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently enrolled in another menopause intervention study
- Does not identify as American Indian or Alaska Native
- Not experiencing menopause
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lisa J Associate Professor, College of Nursing, University of Utah contact
About this study
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.
Read the 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
- Conditions
- Menopause, Vasomotor Symptoms (VMS), Women's Health, Health Disparities, American Indian or Alaska Native
- Being tested
- Waning Moon
- Keywords
- Menopause, Vasomotor Symptoms, Women's Health, American Indian or Alaska Native, Health Disparities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waning MoonBehavioural
Also called MENOGAP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Waning Moon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start11 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Lisa J Taylor-Swanson, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713095
- Sponsor's protocol ID
- 1R34AT013448-01
- Other IDs
- 1R34AT013448-01
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description: De-identified individual participant data will be archived in The Hive, a University of Utah research data repository maintained by the Marriott Library. Data will be shared no later than the time of publication or the end of the project period, whichever occurs first, and will remain available in the repository permanently. Each dataset will receive a Digital Object Identifier (DOI) to link the data to resulting publications. All data will be stripped of identifiers prior to sharing, consistent with participant consent and University of Utah and NIH data sharing policies. Access Criteria: De-identified data will be made publicly available in The Hive under a Creative Commons Attribution-NonCommercial license (CC BY-NC 4.0), which permits use with attribution to the data creators and prohibits commercial use. Data elements determined to carry a risk of indirect or deductive identification (e.g., geospatial indicators below the state level) will instead be provided as
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
- ClinicalTrials.gov ID
- NCT07713095
- Acronym / sponsor ID
- 1R34AT013448-01
- Conditions
- Menopause, Vasomotor Symptoms (VMS), Women's Health, Health Disparities, American Indian or Alaska Native
- Keywords
- Menopause, Vasomotor Symptoms, Women's Health, American Indian or Alaska Native, Health Disparities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Waning Moon Intervention | Experimental | Behavioral: Waning MoonFour-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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Currently enrolled in another menopause intervention study
- Does not identify as American Indian or Alaska Native
- Not experiencing menopause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Waning MoonAlso: MENOGAPWaning 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. | Behavioural | Waning Moon Intervention |
Primary outcome
Feasibility - Feasibility of Intervention Measure (FIM) scale
Time frame: 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.
1 secondary outcome
Intervention Appropriateness Measure (IAM)
Time frame: Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Plan Description: De-identified individual participant data will be archived in The Hive, a University of Utah research data repository maintained by the Marriott Library. Data will be shared no later than the time of publication or the end of the project period, whichever occurs first, and will remain available in the repository permanently. Each dataset will receive a Digital Object Identifier (DOI) to link the data to resulting publications. All data will be stripped of identifiers prior to sharing, consistent with participant consent and University of Utah and NIH data sharing policies. Access Criteria: De-identified data will be made publicly available in The Hive under a Creative Commons Attribution-NonCommercial license (CC BY-NC 4.0), which permits use with attribution to the data creators and prohibits commercial use. Data elements determined to carry a risk of indirect or deductive identification (e.g., geospatial indicators below the state level) will instead be provided as
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa J Associate Professor, College of Nursing, University of Utah contact
Questions about this trial
What is this clinical trial studying?
A study testing Waning Moon in people with Menopause and Vasomotor Symptoms (VMS), run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa J Associate Professor, College of Nursing, University of Utah (801-585-5486, lisa.taylor-swanson@nurs.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Feasibility of Intervention Measure (FIM) scale (time frame: Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.