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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Navigating Menopause with a Mindfulness-Based Group Medical Visit

    Other intervention

    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)

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to the end of the 12-month study period.
2

Body Mass Index

An indirect measure of body fat derived by dividing weight in kilograms by height in meters, squared.

Time frame
From enrollment to the end of the 12-month study period

Secondary outcomes

1

Salivary Alpha Amylase

Salivary α-amylase is a surrogate marker of sympathetic nervous system activity.

Time frame
From enrollment to the end of the 12-month study period.
2

High sensitivity C-Reactive Protein (hs-CRP)

A measure of a protein produced in the liver in response to inflammation, injury or infection.

Time frame
From enrollment to the end of the 12-month study period.
3

Perceived Stress Scale

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.

Time frame
From enrollment to the end of the 12-month study period.
4

PROMIS-29 V2.0

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).

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

Other outcomes

1

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.

Time frame
From enrollment to the end of the 12-month study period.
2

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.

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

Sponsors and contacts

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