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Completed

NCT Number: NCT06297070

Lifestyle Care for Fertility Outcome Evaluation

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

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Key information

Conditions

Fertility Issues Genital Diseases Infertility Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Health Lifestyle Care for Reproductive Well-being pilot program

Behavioral

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.

Other names: Lifestyle Care for Fertility

Primary outcomes

  1. Servings of Fruit

    Time frame: 8 weeks

    Number of servings of fruit consumed each day. A serving is about 1 medium piece, or 1/2 cup of fruit.

  2. Servings of Vegetables

    Time frame: 8 weeks

    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.

  3. Glasses of Water

    Time frame: 8 weeks

    Number of glasses (8 oz) of plain water consumed per day.

  4. Caffeinated Beverages

    Time frame: 8 weeks

    Number of caffeinated beverages consumed per day.

  5. Aerobic Exercise

    Time frame: 8 Weeks

    Frequency of aerobic exercise (min 20 min) in last week.

  6. Strengthening Exercise

    Time frame: 8 weeks

    Frequency of muscle strengthening exercise (min 20 min) in last week.

  7. Stretching Exercise

    Time frame: 8 weeks

    Frequency of stretching exercise in last week.

  8. Sleep Hygiene

    Time frame: 8 weeks

    Frequency of sleep hygiene practices before bed in last week.

  9. Hours of Sleep

    Time frame: 8 weeks

    Average number of hours of sleep per night in last week.

  10. Self Care - Biofeedback

    Time frame: 8 weeks

    Frequency of use of biofeedback in last week.

  11. Self Care - Breathing Exercises

    Time frame: 8 weeks

    Frequency of breathing exercise practice in last week.

  12. Self Care - Guided Imagery

    Time frame: 8 weeks

    Frequency of guided imagery practice in last week.

  13. Self Care - Mindfulness/Meditation

    Time frame: 8 weeks

    Frequency of mindfulness/meditation practice in last week.

  14. Self Care - Progressive Relaxation

    Time frame: 8 weeks

    Frequency of progressive relaxation practice in last week.

  15. Self Care - Journaling/Gratitude Journaling

    Time frame: 8 weeks

    Frequency of journaling or gratitude journaling in last week.

  16. Self Care - Tai Chi/Chi Gong

    Time frame: 8 weeks

    Frequency of Tai Chi or Chi Gong practice in last week.

  17. Self-Care - Massage Therapy

    Time frame: 8 weeks

    Frequency of receipt of massage therapy in last week.

  18. Self Care - Acupuncture/Acupressure

    Time frame: 8 weeks

    Frequency of receipt of acupuncture or acupressure in last week.

  19. Self Care - Nature Walking

    Time frame: 8 weeks

    Frequency of walking in nature in last week.

Secondary outcomes

  1. PROMIS Sleep Disturbance 8a

    Time frame: 8 weeks

    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.

  2. Perceived Stress Scale - 4

    Time frame: 8 weeks

    Composite score (0-16 with higher scores representing a better outcome) measuring self-reported perception of stress.

  3. Infertility Self Efficacy

    Time frame: 8 weeks

    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.

  4. Chemical pregnancy

    Time frame: 8 months

    Pregnancy as confirmed by presence of human chorionic gonadotropin (hCG) within 6 months of program completion.

  5. Stress Change (level of stress: none [0] to worst possible [10]) - SMA

    Time frame: 2 hours

    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.

  6. Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA

    Time frame: 2 hours

    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.

  7. Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA

    Time frame: 2 hours

    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.

  8. Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA

    Time frame: 2 hours

    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.

  9. Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA

    Time frame: 2 hours

    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.

  10. Stress Change (level of stress: none [0] to worst possible [10]) - HWC

    Time frame: 45 minutes

    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.

  11. Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC

    Time frame: 45 minutes

    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.

  12. Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC

    Time frame: 45 minutes

    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.

  13. Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC

    Time frame: 45 minutes

    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.

  14. Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC

    Time frame: 45 minutes

    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.

  15. Recruitment Rate

    Time frame: 4-6 weeks

    Number enrolled over number approached.

  16. Retention Rate

    Time frame: 8 weeks

    Percent of participants retained at each data collection point

  17. Pace of Accrual

    Time frame: 8 weeks

    Number of participants enrolled from each program cohort.

  18. Data Completeness

    Time frame: 8 weeks

    Percent of data collection that is completed

  19. Helpfulness of group sessions in addressing needs

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  20. Coverage of important issues in the sessions

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  21. Helpfulness of tools presented in nutrition session

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  22. Helpfulness of tools presented in movement session

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  23. Helpfulness of tools presented in relaxation and sleep session

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  24. Helpfulness of tools presented in integrate session

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  25. Enjoyed group sessions

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  26. Enjoyed health and wellness coaching session

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  27. Group setting was beneficial

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  28. Comfortable in group setting

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  29. Helpfulness of individual health coaching sessions

    Time frame: 8 weeks

    5-point Likert scale strongly disagree to strongly agree (1 - 5 with higher scores representing better outcomes)

  30. Feedback questionnaire: Location Preference question 1

    Time frame: 8 weeks

    Shared Medical Appointment session location preference. Choices: virtual, in person or no preference.

  31. Feedback questionnaire: Location Preference question 2

    Time frame: 8 weeks

    Health and Wellness Coaching session location preference. Choices: virtual, in person or no preference.

  32. Feedback questionnaire: Number of Sessions question.

    Time frame: 8 weeks

    Opinion on number of sessions. Choices: too few, just right, too many.

  33. Feedback questionnaire: Length of Sessions question.

    Time frame: 8 weeks

    Opinion on length of sessions. Choices: too short, just right, too long.

  34. Rating of level of support during each SMA

    Time frame: 2 hours

    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.

  35. Rating of level of support during HWC

    Time frame: 45 minutes

    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.

  36. Overall level of satisfaction during each SMA

    Time frame: 2 hours

    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.

  37. Overall level of satisfaction during each HWC

    Time frame: 45 minutes

    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.

Sponsors and collaborators

Lead sponsor

Christine Kaiser, LAc, DACM

Other

Registry information

Official study title

Promoting ReprOductive WellbEing Through Shared Medical Appointments and Health Coaching Sessions

Acronym: PROWESS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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