- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07619352
Evaluation of the Effects of Lifestyle Medicine and Mindfulness-based Group Medical Visits on Stress, Microbiome, and Quality of Life in Women Experiencing Perimenopause and Menopause
A Pilot Study to Evaluate the Effects of Lifestyle Medicine and Mindfulness-based Group Medical Visits on Stress, Microbiome, and Quality of Life in Women Experiencing Perimenopause and Menopause
While perimenopause and menopause are natural biological transitions, women may experience a wide range of physical, emotional, and cognitive symptoms. Although pharmacological options for symptom relief are available, these options may not be acceptable or suitable for all women. Integrative approaches for symptom relief, offered through group medical visits, may complement traditional therapies by increasing access to providers, allowing more time for focused education, and fostering supportive discussions with other women experiencing similar symptoms of perimenopause or menopause.
The purpose of this study is to assess the effectiveness of eight monthly group medical visits that incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Individual outcomes, obtained before the group medical visits begin, at each monthly group medical visit, and four months after the group medical visits are completed, will include measures of participants' perimenopause or menopause symptoms, stress, inflammation, microbiome (good bacteria in the body), height/weight, body mass index (BMI), systolic and diastolic blood pressure, and self-reported perceptions of physical, mental, and social health.
Each 120-minute monthly group medical visit, led by a specially trained nurse practitioner and a mindfulness instructor, will include a brief physical assessment, educational discussions related to menopause and lifestyle medicine, experiential mindfulness practices, and the development of individual health and well-being goals.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Group Medical Visits (GMVs), also known as Shared Medical Appointments (SMAs), were introduced in literature in the 1970s, and despite support from organizations such as the American Academy of Family Physicians they have been slow to gain traction in the healthcare field. GMVs provide benefits to patients including increased access and time with the provider, improved quality of care, nonpharmacologic treatment, and the ability to share self-management tools. There is evidence that the GMV experience may impact clinical outcomes in patients with various diseases and conditions such as chronic pain, diabetes, breast cancer, and Multiple Sclerosis. However, the effects of GMVs on clinical and non-clinical outcomes for women - particularly for female-specific conditions like menopause - are not well established.
There is a clear demand for innovative and accessible care models like GMVs to address gaps in menopause care for women. More recently, a number of women are opting out of hormone therapy for menopause and exploring more integrative, holistic approaches to healthcare. Alternative approaches may include Lifestyle Medicine (LM) and mindfulness-based practices. Studies have demonstrated that mindfulness strategies, like meditation or yoga, can be a beneficial component to GMVs. Lifestyle Medicine, as defined by American College of Lifestyle Medicine (ACLM) is a "medical specialty that uses therapeutic lifestyle interventions as a primary modality to treat chronic conditions including, but not limited to, cardiovascular diseases, type 2 diabetes, and obesity". When applied intensively, Lifestyle Medicine has even been shown to reverse chronic conditions. Furthermore, Lifestyle Medicine interventions based on diet, physical activity and sleep hygiene have been shown to improve cardiometabolic outcomes. These types of choices for menopause interventions need support from knowledgeable providers of integrative techniques.
In addition to lifestyle and mindfulness-based interventions, investigating physiological factors in stress such as the microbiome offers a more comprehensive view of health during menopause. The gut microbiome, which consists of the ecosystem of microorganisms inhabiting the gastrointestinal tract, is known to undergo significant changes with aging and menopause. As the gut microbiome plays a key role in psychological stress and overall health, a better understanding of the changes taking place in the microbiome during menopause will help identify areas for improvement and potential interventions for women during this transition.
The aim of this pilot study is to investigate the measurable effects of Lifestyle Medicine GMVs and mindfulness on stress, microbiome, and quality of life in women experiencing perimenopause and menopause. It is anticipated that the GMVs and mindfulness techniques will provide beneficial outcomes for those participating in the study, including a reduction of stress, inflammation, BMI, blood pressure and an increase in resilience. Additionally, the investigators anticipate positive trends in self-reported perceptions of health such as physical, mental, and social quality of life. Potential challenges, risks or pitfalls of the study include recruiting a diverse patient population, self-reported data are subject to bias, and the billing structure for GMVs.
This research is significant to women experiencing peri- and post-menopause as it will provide data for future studies to implement more effective, engaging models for managing their health and well-being. Provider-patient contact time has decreased over the years, which can lead to poor health outcomes for patients. GMVs facilitate group healthcare without sacrificing personalization, patient education, and clinical components such as measuring vitals. The implications on a societal level are potential outcomes such as increased access to patient-centered, integrative healthcare, as well as customized non-pharmacological treatment for menopausal women. GMVs provide, or augment, solutions for women who elect not to take hormonal therapy for menopause symptoms. This GMV for the menopausal population will be called Navigating Menopause with a Mindfulness-Based Group Medical Visit.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Beth A Steinberg, PhD, RN
- Telefonnummer: 614-406-7067
- E-mail: beth.steinberg@osumc.edu
Undersøgelse Kontakt Backup
- Navn: Maryanna Klatt, PhD
- Telefonnummer: 614-293-3644
- E-mail: maryanna.klatt@osumc.edu
Studiesteder
-
-
Ohio
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University
-
Kontakt:
- Beth Steinberg, PhD, RN
- Telefonnummer: 614-406-7067
- E-mail: beth.steinberg@osumc.edu
-
Kontakt:
- Maryanna Klatt, PhD
- Telefonnummer: 614-293-3644
- E-mail: maryanna.klatt@osumc.edu
-
Underforsker:
- Beth Steinberg, PhD, RN
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Biological female.
- Age 40 to 60.
- Irregular menstruation for 3 months and experiencing perimenopause or menopause as determined by reporting at least one symptom on the Menopause Quality of Life Questionnaire (MENQOL).
- Ability to attend group medical visits monthly, in-person for 8 months, at The Ohio State University Center for Integrative Health as well as the baseline and end of study visit.
- Ability to participate in the Mindfulness in Motion (MIM) study activities.
- Ability and willingness to download MyCap, the smartphone app that securely links participant study responses to the REDCap study project.
- WiFi connectivity or LTE to allow use of MyCap when not at OSU study site
Exclusion Criteria:
- Participants with surgically induced menopause, e.g., hysterectomy, oophorectomy.
- Currently receiving or planning to receive hormone therapy for perimenopausal or menopausal symptoms.
- Currently taking or planning to take hormonal contraceptives.
- Currently taking or planning to take hormone altering medications; i.e. Taxol.
- Currently taking probiotics, Siberian rhubarb (Rheum rhaponticum), Black cohosh (Actaea racemosa), Chaste tree berry (Vitex agnus-castus).
- Inability to read and/or understand English (consent and questionnaires in English).
- Current severe alcohol or substance abuse disorder.
- Participants with documented cognitive disorder that limits the ability to independently read, understand, and/or complete the survey or biological; i.e. dementia, Alzheimer's or biological tests.
- Participants with major psychiatric disorders not controlled by medication or other psychiatric treatments.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention Group
Research subjects will participate in eight monthly group medical visits that incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause.
Each group medical visit will be 120 minutes in length.
|
Over the course of eight months, the group medical visits will incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Each group medical visit will be 120 minutes in length and will include:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Blood Pressure
Tidsramme: From enrollment to the end of the 12-month study period.
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Blood pressure is the force exerted by circulating blood against the walls of blood vessels due to heart's pumping action.
It is measured in mmHg.
The upper number is the measurement during the heartbeat (systolic) and the lower number is while the heart is at rest (diastolic).
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From enrollment to the end of the 12-month study period.
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Body Mass Index
Tidsramme: From enrollment to the end of the 12-month study period
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An indirect measure of body fat derived by dividing weight in kilograms by height in meters, squared.
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From enrollment to the end of the 12-month study period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Salivary Alpha Amylase
Tidsramme: From enrollment to the end of the 12-month study period.
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Salivary α-amylase is a surrogate marker of sympathetic nervous system activity.
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From enrollment to the end of the 12-month study period.
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High sensitivity C-Reactive Protein (hs-CRP)
Tidsramme: From enrollment to the end of the 12-month study period.
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A measure of a protein produced in the liver in response to inflammation, injury or infection.
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From enrollment to the end of the 12-month study period.
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Perceived Stress Scale
Tidsramme: From enrollment to the end of the 12-month study period.
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The Perceived Stress Scale-10 (PSS-10) is a 10-item self-report measure of perceived stress.
It is a measure of the degree to which situations in one's life are appraised as stressful over the past month.
The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often).
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
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From enrollment to the end of the 12-month study period.
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PROMIS-29 V2.0
Tidsramme: From enrollment to the end of the 12-month study period.
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The PROMIS - 29 V2.0 is a comprehensive health assessment tool that used to assess functioning and well-being.
It assesses seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social activity and sleep disturbance plus a pain intensity rating).
Each domain has 4 items with the responses using a Likert-type scale of 1 through 5 with responses related to frequency or severity of symptoms and pain intensity on scale of 0-10.
Scores around 50 represent the general population average.
Worse than average: Scores above 55 generally indicate higher symptom burdens (Anxiety, Depression, Fatigue, Sleep, Pain Interference).Better than average: Scores below 45 indicate better functionality (Physical Function, Social Roles).
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From enrollment to the end of the 12-month study period.
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The Menopause-specific Quality of Life Questionnaire
Tidsramme: From enrollment to the end of the 12-month study period.
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The MENQOL is a 29-item self-report tool that assesses the impact of menopausal symptoms over the past month on health-related quality of life in the immediate post-menopausal period.
Items are grouped into four domains of menopausal symptoms that include vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
Responses to each item are first rated as "present" or "not present", and if present, a Likert scale is used to describe perceptions of how bothersome symptoms are ranging from zero (not bothersome) to six (extremely bothersome); possible scores on each item ranges from one to eight.
Means are then computed for each subscale.
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From enrollment to the end of the 12-month study period.
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The Menstrual Distress Questionnaire
Tidsramme: From enrollment to the end of the 12-month study period.
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The Menstrual Distress Questionnaire (MEDI-Q) is a validated tool designed to comprehensively assess menstrual-related distress.
It includes 25 items covering symptoms such as pain, cognitive changes, and gastrointestinal issues, evaluating their impact on functioning, quality of life, and frequency, and provides four overall indices for a complete assessment.A Total Score (MEDI-Q Total) represents overall menstrual distress burden and is derived from responses across all items.
A total score >20 indicates clinical relevant menstrual distress.
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From enrollment to the end of the 12-month study period.
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Physical Activity Vital Sign
Tidsramme: From enrollment to the end of the 12-month study period.
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A self-report two question assessment designed to gage physical activity over past week (question 1) and over a typical week (questions 2).
Activity is reported in minutes for both questions.
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From enrollment to the end of the 12-month study period.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vaginal Microbiome Analysis
Tidsramme: From enrollment to the end of the 12-month study period.
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16S ribosomal RNA sequencing analysis will be used to analyze vaginal secretions to determine microbial diversity, particularly assessing tryptophan since it has been shown to correlate with estrogen regulation.
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From enrollment to the end of the 12-month study period.
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Rectal Microbiome Analysis
Tidsramme: From enrollment to end of the 12-month study period.
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Fecal matter will be assessed using 16S ribosomal RNA sequencing to determine microbial diversity, particularly looking at tryptophan metabolism since it has been shown to correlate with estrogen regulation.
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From enrollment to end of the 12-month study period.
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 20260389
Plan for individuelle deltagerdata (IPD)
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