PostmenopausalNCT05590507
Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women
A study testing Mindfulness Audio Recordings in people with Postmenopausal, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to figure out if postmenopausal women find a mindfulness audio recording acceptable for use along with physical activity, and to find out if this tool is helpful in increasing daily physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal
- What is being tested?
- Mindfulness Audio Recordings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2022to 21 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients self-report as being > 1 year postmenopausal.
- Patients are able to walk without a walking aid.
- Patients own and know how to operate a smart phone or tablet.
- Patients are willing and able to complete the activity monitoring.
- Patients are self-reportedly underactive.
Who cannot join
- Patients are < 1 year postmenopausal.
- Patients require a walking aid for daily mobility.
- Patients do not own a smartphone or table, or are unwilling to use such a device for the purposes of the study.
- Patients' primary form of exercise is swimming (the activity monitors are not waterproof).
- Patients are unable or unwilling to complete activity monitoring.
- Patients are unable to provide informed consent independently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women
The purpose of this study is to figure out if postmenopausal women find a mindfulness audio recording acceptable for use along with physical activity, and to find out if this tool is helpful in increasing daily physical activity.
- Conditions
- Postmenopausal
- Being tested
- Mindfulness Audio Recordings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Audio RecordingsBehavioural
A 5-minute audio file aimed to increase likelihood of experiencing positive affect associated with physical activity. Participants will listen to a mindfulness audio file at the beginning of each physical activity session they choose to engage in during weeks 2-4
| Study group | Role | What they receive |
|---|---|---|
| Group A/Intervention | Experimental | Subjects will use mindfulness audio recordings along with their physical activity, and will receive a weekly health coaching phone call along with supplemental educational materials. Receives: Behavioral: Mindfulness Audio Recordings |
| Group B/Control | No intervention | Subjects will receive education materials on healthy habits for increasing physical activity based on the National Institutes of Health, and bi-weekly check-in phone call. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of a mindfulness-based physical activity intervention
Number of subjects to rate the remotely-accessible and physical activity-targeted mindfulness audio file as acceptable
Measured: 4 weeks
Secondary outcomes (1)
Daily physical activity
Number of subjects to have an increase in objectively measured daily physical activity variables (such as step counts) recorded by ActiGraph activity monitor
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start28 Dec 2022
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Fortune Ngufor, Mayo Clinic
- Investigators
- Emma Fortune-Ngufor, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590507
- Sponsor's protocol ID
- 22-007713
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05590507
- Acronym / sponsor ID
- 22-007713
- Conditions
- Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 21 Oct 2022 (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.
The purpose of this study is to figure out if postmenopausal women find a mindfulness audio recording acceptable for use along with physical activity, and to find out if this tool is helpful in increasing daily physical activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A/Intervention | Experimental | Behavioral: Mindfulness Audio RecordingsSubjects will use mindfulness audio recordings along with their physical activity, and will receive a weekly health coaching phone call along with supplemental educational materials. |
| Group B/Control | No intervention | –Subjects will receive education materials on healthy habits for increasing physical activity based on the National Institutes of Health, and bi-weekly check-in phone call. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients self-report as being > 1 year postmenopausal.
- Patients are able to walk without a walking aid.
- Patients own and know how to operate a smart phone or tablet.
- Patients are willing and able to complete the activity monitoring.
- Patients are self-reportedly underactive.
Key exclusion criteria (6 listed)
- Patients are < 1 year postmenopausal.
- Patients require a walking aid for daily mobility.
- Patients do not own a smartphone or table, or are unwilling to use such a device for the purposes of the study.
- Patients' primary form of exercise is swimming (the activity monitors are not waterproof).
- Patients are unable or unwilling to complete activity monitoring.
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 |
|---|---|---|
| Mindfulness Audio RecordingsA 5-minute audio file aimed to increase likelihood of experiencing positive affect associated with physical activity. Participants will listen to a mindfulness audio file at the beginning of each physical activity session they choose to engage in during weeks 2-4 | Behavioural | Group A/Intervention |
Primary outcome
Acceptability of a mindfulness-based physical activity intervention
Time frame: 4 weeks
Number of subjects to rate the remotely-accessible and physical activity-targeted mindfulness audio file as acceptable
1 secondary outcome
Daily physical activity
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Postmenopausal
RecruitingPhase 3
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Metastatic Breast Cancer
Recruiting
Methylation Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
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. This study is not recruiting at the moment.
Emma Fortune-Ngufor, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Audio Recordings in people with Postmenopausal, run by Mayo Clinic at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of a mindfulness-based physical activity intervention (time frame: 4 weeks). 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 21 Mar 2024.