Lifestyle Care for Fertility Outcome Evaluation (PROWESS)

Promoting ReprOductive WellbEing Through Shared Medical Appointments and Health Coaching Sessions

An observational outcome evaluation of the Lifestyle Care for Fertility program.

Study Overview

• Status: Completed
• Conditions: Fertility Issues
• Intervention / Treatment: Behavioral: Whole Health Lifestyle Care for Reproductive Well-being pilot program

Detailed Description

This outcome evaluation will examine the feasibility and acceptability of the Whole Health Lifestyle Care for Reproductive Well-being Pilot Program ("Lifestyle Care for Fertility" or LCF) and collection of health behavior and patient-reported outcomes. Secondarily, it will also examine the longitudinal changes in health behaviors and patient-reported outcomes of participants in the Lifestyle Care for Fertility program

The Lifestyle Care for Fertility program serves women who have a fertility-related diagnosis. The program consists of an individual Integrative Health and Medicine (IHM) consultation with a CWH IHM provider, 4 Shared Medical Appointments (SMA), and 4 individual Health and Wellness Coaching (HWC) sessions. The SMA sessions occur at the UH CWH Beachwood office conference and movement rooms. The HWC sessions are virtual. The consultations are either virtual or in person at UH CWH Beachwood. Topics include meditation, sleep, yoga/exercise/movement, acupuncture, and nutrition

Participation in the program is not contingent on participation in the outcome evaluation. Patients with a uterus aged 18-50 who have a fertility-related diagnosis are eligible to participate in the program. Participants in the outcome evaluation will be a subset of the participants in the program who give their consent to researchers to collect survey and EHR data.

The outcome evaluation will collect data at 4 weeks, 8 weeks, and before, after, and in between each of the 8 weekly sessions. Data collected at baseline include demographics, PROMIS Sleep Disturbance 8a, Perceived Stress Scale 4 (PSS-4), Infertility Self Efficacy Scale (ISE), and current Health Behaviors (HB). The HB survey will be administered between Sessions 1-8, as well as after Session 8, to observe any longitudinal changes. Patients will complete the PROMIS Sleep Disturbance 8a, PSS-4, and ISE at 4 weeks and 8 weeks. Pre- and post-session data includes 0-10 NRS ratings of stress, energy, focus, well-being, perceived support (post-only), and satisfaction (post-only). Additionally, participants will complete a satisfaction survey post Session 8. All data will be collected in REDCap via a text message or email link sent to the participant. Research staff will review the participant's medical record to collect data on the participant's demographics and clinical characteristics at baseline, and to collect chemical pregnancy data at six months after the 8 sessions have been completed. Attendance data about participants will also be collected.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Study participants will be patients of University Hospitals Connor Whole Health who have a fertility-related diagnosis and who are participating in the Lifestyle Care for Fertility program

Description

Inclusion Criteria:

• Adult with a uterus aged from 18 to 50 years
• Participating in the Lifestyle Care for Fertility program
• Able to speak and understand English.
• Has email address and access to mobile device with a functioning data plan.
• Infertility-related diagnosis

Exclusion Criteria:

• Age < 18 or > 50 years
• Having a significant and uncorrected visual, hearing, or cognitive impairment
• Inability to provide consent
• Current pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Servings of Fruit	Number of servings of fruit consumed each day. A serving is about 1 medium piece, or 1/2 cup of fruit.	8 weeks
Servings of Vegetables	Number of servings of vegetables consumed each day. A serving is about 1 cup of raw leafy vegetables, 1/2 cup of other cooked or raw vegetables, or 3/4 cup of raw vegetable juice.	8 weeks
Glasses of Water	Number of glasses (8 oz) of plain water consumed per day.	8 weeks
Caffeinated Beverages	Number of caffeinated beverages consumed per day.	8 weeks
Aerobic Exercise	Frequency of aerobic exercise (min 20 min) in last week.	8 Weeks
Strengthening Exercise	Frequency of muscle strengthening exercise (min 20 min) in last week.	8 weeks
Stretching Exercise	Frequency of stretching exercise in last week.	8 weeks
Sleep Hygiene	Frequency of sleep hygiene practices before bed in last week.	8 weeks
Hours of Sleep	Average number of hours of sleep per night in last week.	8 weeks
Self Care - Biofeedback	Frequency of use of biofeedback in last week.	8 weeks
Self Care - Breathing Exercises	Frequency of breathing exercise practice in last week.	8 weeks
Self Care - Guided Imagery	Frequency of guided imagery practice in last week.	8 weeks
Self Care - Mindfulness/Meditation	Frequency of mindfulness/meditation practice in last week.	8 weeks
Self Care - Progressive Relaxation	Frequency of progressive relaxation practice in last week.	8 weeks
Self Care - Journaling/Gratitude Journaling	Frequency of journaling or gratitude journaling in last week.	8 weeks
Self Care - Tai Chi/Chi Gong	Frequency of Tai Chi or Chi Gong practice in last week.	8 weeks
Self-Care - Massage Therapy	Frequency of receipt of massage therapy in last week.	8 weeks
Self Care - Acupuncture/Acupressure	Frequency of receipt of acupuncture or acupressure in last week.	8 weeks
Self Care - Nature Walking	Frequency of walking in nature in last week.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemical pregnancy	Pregnancy as confirmed by presence of human chorionic gonadotropin (hCG) within 6 months of program completion.	8 months
Recruitment Rate	Number enrolled over number approached.	4-6 weeks
Retention Rate	Percent of participants retained at each data collection point	8 weeks
Pace of Accrual	Number of participants enrolled from each program cohort.	8 weeks
Data Completeness	Percent of data collection that is completed	8 weeks
PROMIS Sleep Disturbance 8a	Composite score (8 -40 with higher scores representing a better outcome) measuring self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours within the past seven days.	8 weeks
Perceived Stress Scale - 4	Composite score (0-16 with higher scores representing a better outcome) measuring self-reported perception of stress.	8 weeks
Infertility Self Efficacy	Composite score (16-144 with higher scores representing a better outcome) measuring self-reported perceived self-efficacy for coping with a diagnosis and treatment for infertility.	8 weeks
Stress Change (level of stress: none [0] to worst possible [10]) - SMA	Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in stress level from pre to post each of the 4 shared medical appointment sessions.	2 hours
Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA	Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in anxiety level from pre to post each of the 4 shared medical appointment sessions.	2 hours
Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA	Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in energy level from pre to post each of the 4 shared medical appointment sessions.	2 hours
Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA	Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in focus level from pre to post each of the 4 shared medical appointment sessions.	2 hours
Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA	Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in wellbeing level from pre to post each of the 4 shared medical appointment sessions.	2 hours
Stress Change (level of stress: none [0] to worst possible [10]) - HWC	Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in stress level from pre to post each of the 4 health and wellness coaching sessions.	45 minutes
Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC	Change in 11 point numerical rating scale. Range from -11 to 11, with lower scores representing better outcomes: Change in anxiety level from pre to post each of the 4 health and wellness coaching sessions.	45 minutes
Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC	Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in energy level from pre to post each of the 4 health and wellness coaching sessions.	45 minutes
Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC	Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in focus level from pre to post each of the 4 health and wellness coaching sessions.	45 minutes
Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC	Change in 11 point numerical rating scale. Range from -11 to 11, with higher scores representing better outcomes: Change in wellbeing level from pre to post each of the 4 health and wellness coaching sessions.	45 minutes
Helpfulness of group sessions in addressing needs	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Coverage of important issues in the sessions	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Helpfulness of tools presented in nutrition session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Helpfulness of tools presented in movement session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Helpfulness of tools presented in relaxation and sleep session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Helpfulness of tools presented in integrate session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Enjoyed group sessions	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Enjoyed health and wellness coaching session	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Group setting was beneficial	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Comfortable in group setting	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Helpfulness of individual health coaching sessions	5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)	8 weeks
Feedback questionnaire: Location Preference question 1	Shared Medical Appointment session location preference. Choices: virtual, in person or no preference.	8 weeks
Feedback questionnaire: Location Preference question 2	Health and Wellness Coaching session location preference. Choices: virtual, in person or no preference.	8 weeks
Feedback questionnaire: Number of Sessions question.	Opinion on number of sessions. Choices: too few, just right, too many.	8 weeks
Feedback questionnaire: Length of Sessions question.	Opinion on length of sessions. Choices: too short, just right, too long.	8 weeks
Rating of level of support during each SMA	11-point Likert scale not supported to very well supported (0 - 10 with higher scores representing better outcomes): Level of support received during each of the 4 shared medical appointment sessions.	2 hours
Rating of level of support during HWC	11-point Likert scale not supported to very well supported (0 - 10 with higher scores representing better outcomes): Level of support received during each of the 4 health and wellness coaching sessions.	45 minutes
Overall level of satisfaction during each SMA	11-point Likert scale not at all satisfied to very well satisfied (0 - 10 with higher scores representing better outcomes): Overall level of satisfaction with each of the 4 shared medical appointment sessions.	2 hours
Overall level of satisfaction during each HWC	11-point Likert scale not at all satisfied to very well satisfied (0 - 10 with higher scores representing better outcomes): Overall level of satisfaction with each of the 4 health and wellness coaching sessions.	45 minutes

Collaborators and Investigators

• Sponsor: Christine Kaiser, LAc, DACM
• Investigators: Principal Investigator: Christine Kaiser, DACM LAc, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): June 20, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; fertility; health coaching; shared medical appointments
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: STUDY20231406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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