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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07619352
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

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)

Study Details

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 Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Oct 1, 2027
Completion
Aug 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Blood Pressure [ Time Frame: From enrollment to the end of the 12-month study period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Beth Steinberg, PhD, RN
[email protected]
614-406-7067
Maryanna Klatt, PhD
[email protected]
614-293-3644
Beth Steinberg, PhD, RN (SUB_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Menopause
By specialty
Women's healthFertility
By research site
The Ohio State University· Columbus, OH

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