nctId: NCT06297070 id: STUDY20231406 briefTitle: Lifestyle Care for Fertility Outcome Evaluation acronym: PROWESS overallStatus: RECRUITING date: 2024-01-24 date: 2025-06-01 date: 2025-08-01 date: 2024-03-06 date: 2024-03-08 name: Christine Kaiser, LAc, DACM class: OTHER briefSummary: An observational outcome evaluation of the Lifestyle Care for Fertility program. conditions: Fertility Issues studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 55 type: ESTIMATED name: Whole Health Lifestyle Care for Reproductive Well-being pilot program measure: Servings of Fruit measure: Servings of Vegetables measure: Glasses of Water measure: Caffeinated Beverages measure: Aerobic Exercise measure: Strengthening Exercise measure: Stretching Exercise measure: Sleep Hygiene measure: Hours of Sleep measure: Self Care - Biofeedback measure: Self Care - Breathing Exercises measure: Self Care - Guided Imagery measure: Self Care - Mindfulness/Meditation measure: Self Care - Progressive Relaxation measure: Self Care - Journaling/Gratitude Journaling measure: Self Care - Tai Chi/Chi Gong measure: Self-Care - Massage Therapy measure: Self Care - Acupuncture/Acupressure measure: Self Care - Nature Walking measure: PROMIS Sleep Disturbance 8a measure: Perceived Stress Scale - 4 measure: Infertility Self Efficacy measure: Chemical pregnancy measure: Stress Change (level of stress: none [0] to worst possible [10]) - SMA measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA measure: Stress Change (level of stress: none [0] to worst possible [10]) - HWC measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC measure: Recruitment Rate measure: Retention Rate measure: Pace of Accrual measure: Data Completeness measure: Helpfulness of group sessions in addressing needs measure: Coverage of important issues in the sessions measure: Helpfulness of tools presented in nutrition session measure: Helpfulness of tools presented in movement session measure: Helpfulness of tools presented in relaxation and sleep session measure: Helpfulness of tools presented in integrate session measure: Enjoyed group sessions measure: Enjoyed health and wellness coaching session measure: Group setting was beneficial measure: Comfortable in group setting measure: Helpfulness of individual health coaching sessions measure: Feedback questionnaire: Location Preference question 1 measure: Feedback questionnaire: Location Preference question 2 measure: Feedback questionnaire: Number of Sessions question. measure: Feedback questionnaire: Length of Sessions question. measure: Rating of level of support during each SMA measure: Rating of level of support during HWC measure: Overall level of satisfaction during each SMA measure: Overall level of satisfaction during each HWC sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University Hospitals Cleveland Medical Center status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Christine Kaiser, DACM LAc role: CONTACT phone: 216-285-4070 email: Christine.Kaiser@UHhospitals.org name: Jessica Surdam, MPH role: CONTACT phone: 216-844-7925 email: Jessica.Surdam@UHhospitals.org lat: 41.4995 lon: -81.69541 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-20 uploadDate: 2024-01-10T14:17 filename: Prot_SAP_000.pdf size: 238937 hasResults: False