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 your 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause; Perimenopause
• Intervention / Treatment: Other: Navigating Menopause with a Mindfulness-Based Group Medical Visit

Detailed Description

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 the patients participating in the study, including a reduction of stress, inflammation, BMI, blood pressure and an increase in resilience. Additionally, we 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth A Steinberg, PhD, RN; Phone Number: 614-406-7067; Email: beth.steinberg@osumc.edu
• Study Contact Backup: Name: Maryanna Klatt, PhD; Phone Number: 614-293-3644; Email: maryanna.klatt@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
      • Contact: Beth Steinberg, PhD, RN; Phone Number: 614-406-7067; Email: beth.steinberg@osumc.edu
      • Contact: Maryanna Klatt, PhD; Phone Number: 614-293-3644; Email: maryanna.klatt@osumc.edu
      • Sub-Investigator: Beth Steinberg, PhD, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Biological female.
2. Age 40 to 60.
3. 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).
4. 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.
5. Ability to participate in the Mindfulness in Motion (MIM) study activities.
6. Ability and willingness to download MyCap, the smartphone app that securely links participant study responses to the REDCap study project.
7. WiFi connectivity or LTE to allow use of MyCap when not at OSU study site

Exclusion Criteria:

1. Participants with surgically induced menopause, e.g., hysterectomy, oophorectomy.
2. Currently receiving or planning to receive hormone therapy for perimenopausal or menopausal symptoms.
3. Currently taking or planning to take hormonal contraceptives.
4. Currently taking or planning to take hormone altering medications; i.e. Taxol.
5. Currently taking probiotics, Siberian rhubarb (Rheum rhaponticum), Black cohosh (Actaea racemosa), Chaste tree berry (Vitex agnus-castus).
6. Inability to read and/or understand English (consent and questionnaires in English).
7. Current severe alcohol or substance abuse disorder.
8. 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.
9. Participants with major psychiatric disorders not controlled by medication or other psychiatric treatments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Navigating Menopause with a Mindfulness-Based Group Medical Visit; 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: Check-in/physical assessment/self-report surveys (15 min); Education/Lifestyle Medicine session (30-45 min); Mindfulness in Motion (MIM) (30 min); Goals/Questions and 1:1 visits as needed (30 min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	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).	From enrollment to the end of the 12-month study period.
Body Mass Index	An indirect measure of body fat derived by dividing weight in kilograms by height in meters, squared.	From enrollment to the end of the 12-month study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Alpha Amylase	Salivary α-amylase is a surrogate marker of sympathetic nervous system activity.	From enrollment to the end of the 12-month study period.
High sensitivity C-Reactive Protein (hs-CRP)	A measure of a protein produced in the liver in response to inflammation, injury or infection.	From enrollment to the end of the 12-month study period.
Perceived Stress Scale	A self-report measure for assessing how unpredictable, uncontrollable, and overwhelming individuals perceive their lives.	From enrollment to the end of the 12-month study period.
PROMIS-29 V2.0	A comprehensive self-report health assessment tool 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).	From enrollment to the end of the 12-month study period.
The Menopause-specific Quality of Life Questionnaire	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.	From enrollment to the end of the 12-month study period.
The Menstrual Distress Questionnaire	A self-report 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.	From enrollment to the end of the 12-month study period.
Physical Activity Vital Sign	A self-report two question assessment designed to gage physical activity over past week (question 1) and over a typical week (questions 2).	From enrollment to the end of the 12-month study period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Microbiome Analysis	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.	From enrollment to the end of the 12-month study period.
Rectal Microbiome Analysis	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.	From enrollment to end of the 12-month study period.

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; menopause; stress; microbiome; women; perimenopause
• Other Study ID Numbers: 20260389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No