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