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

Starting soon · Not applicable

Conditions studied: Perimenopause, Menopause

In brief

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.

Key facts

Study ID

NCT07619352

Run by

Ohio State University

People needed

40

Starts

2026-08-01

Expected to finish

2028-08-30

Last updated by the study team

2026-06-23

Who can join

Age: 40 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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