Lifestyle Care for Fertility Outcome Evaluation

NCT06297070 | Completed

• 1 other identifier: STUDY20231406
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fertility Issues

Keywords

fertility; shared medical appointments; health coaching; quality of life

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (37)

• PROMIS Sleep Disturbance 8a

  8 weeks

• Perceived Stress Scale - 4

  8 weeks

• Infertility Self Efficacy

  8 weeks

• Chemical pregnancy

  8 months

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

  2 hours

Interventions

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.

Also known as: Lifestyle Care for Fertility

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Christine Kaiser, LAc, DACM: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Fertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Christine Kaiser, DACM LAc

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: January 24, 2024
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)