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

NCT07619352 | Not Yet Recruiting

• 1 other identifier: 20260389
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perimenopause; Menopause

Keywords

perimenopause; menopause; stress; microbiome; quality of life; women

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Salivary Alpha Amylase

  From enrollment to the end of the 12-month study period.

• High sensitivity C-Reactive Protein (hs-CRP)

  From enrollment to the end of the 12-month study period.

• Perceived Stress Scale

  From enrollment to the end of the 12-month study period.

• PROMIS-29 V2.0

  From enrollment to the end of the 12-month study period.

• The Menopause-specific Quality of Life Questionnaire

  From enrollment to the end of the 12-month study period.

Other Outcomes (2)

• Vaginal Microbiome Analysis

  From enrollment to the end of the 12-month study period.

• Rectal Microbiome Analysis

  From enrollment to end of the 12-month study period.

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Navigating Menopause with a Mindfulness-Based Group Medical Visit OTHER

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: 1. Check-in/physical assessment/self-report surveys (15 min) 2. Education/Lifestyle Medicine session (30-45 min) 3. Mindfulness in Motion (MIM) (30 min) 4. Goals/Questions and 1:1 visits as needed (30 min)

Intervention Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Biological female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Central Study Contacts

Beth A Steinberg, PhD, RN

CONTACT

614-406-7067; beth.steinberg@osumc.edu

Maryanna Klatt, PhD

CONTACT

614-293-3644; maryanna.klatt@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

US (1)