Promoting ReprOductive WellbEing Through Shared Medical Appointments and Health Coaching Sessions
Conditions: Fertility Issues
Sponsor: Christine Kaiser, LAc, DACM

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 1 of 9
PROTOCOL TITLE:
Promoting ReprOductive WellbEing through Shared medical appointments and health coaching 
Sessions (PROWESS)
PRINCIPAL INVESTIGATOR:
Christine Kaiser, DACM, LAc, FABORM
UH Connor Whole Health
(216)285-4070
CHRISTINE.KAISER@UHhospitals.org
UH FACULTY ADVISOR:
If the principal investigator’s primary role at UH is resident, fellow or student, identify a faculty 
advisor.
☒ N/A
OTHER DEPARTMENTS INVOLVED IN THIS STUDY (IF APPLICABLE):    
☒  N/A   
DATE: 
12/20/2023 

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 2 of 9
1. Objectives 
1) To 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 
2) To examine the longitudinal changes in health behaviors, and patient reported 
outcomes of participants in the Lifestyle Care for Fertility program
2. Background
Approximately 10 to 15% of couples are impacted by infertility (1). Struggles with fertility can 
have a wide range of effects on an individual’s and couple’s life including physical, emotional, 
sexual, spiritual, and financial aspects. Studies have shown that infertile couples experience 
significant emotional distress including anxiety, grief, loss, and depression (2). Fertility 
treatments can be physically demanding and uncomfortable, with side effects including pain, 
mood changes, headaches, bloating, hot flashes, and sleep disturbance. Recently, research is 
starting to focus more on diet and lifestyle factors as a way to improve time to pregnancy and 
therefore lessen the burden of infertility felt by couples (3, 4, 5). Lifestyle factors are the 
modifiable habits and ways of life that can greatly influence overall health and well-being, 
including fertility. Many lifestyle factors such as nutrition, weight, exercise, psychological stress, 
environmental toxins, and others can have substantial effects on fertility.
A combination lifestyle approach is an evidence-based practice in which nutrition, exercise, and 
integrative therapies such as mindfulness training and stress management have been shown to 
improve health and well-being, as well as positively impact chronic disease management (6). 
Evidence shows that patient-centered coaching yields positive results related to lifestyle 
behaviors (7). Health and wellness coaching (HWC) can provide significant value to patients’ 
healthcare in the combination lifestyle approach (7). Applying the concept of HWC to fertility 
patients has the potential to yield improved fertility outcomes, decreased time to pregnancy, 
and enhanced well-being during the fertility journey, healthier pregnancy as pre-conception is 
an ideal time to optimize diet and lifestyle habits, and impact future generations with better 
health and better health habits. This combination lifestyle approach is particularly important for 
women with polycystic ovarian syndrome (PCOS) which is one of the most common causes of 
female infertility. International evidence-based guidelines for the management of PCOS include 
the recommendation of healthy lifestyle behaviors encompassing healthy eating, weight loss, 
and regular exercise, which are all supported through HWC (8).     
3. Inclusion and Exclusion Criteria
Inclusion Criteria
1.
Adult with a uterus aged from 18 to 50 years 
2.
Participating in the Lifestyle Care for Fertility program
3.
Able to speak and understand English.

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 3 of 9
4.
Has email address and access to mobile device with a functioning data plan.
5.
Infertility-related diagnosis
Exclusion Criteria
1.
Age < 18 or > 50 years 
2.
Having a significant and uncorrected visual, hearing, or cognitive impairment
3.
Inability to provide consent
4.
Current pregnancy
4. Study Design
This is an observational outcome evaluation of the Lifestyle Care for Fertility program. 
5. Study Procedures
Setting
Consent will take place either virtually via telehealth or in a private room at the UH Connor 
Whole Health (CWH) Beachwood office. The shared medical appointments (SMA) occur at the 
CWH Beachwood office and the individual Health and Wellness Coaching (HWC) sessions are 
virtual. Data will be collected via a link to REDCap sent to participants’ mobile device.
Participants and Recruitment:
Study participants will be patients of UH CWH who have a fertility-related diagnosis and who 
are participating in LCF. Patients are referred to the program by their Integrative Medicine 
provider. The HWC, who is also IRB approved research staff, will then screen program 
participants for research eligibility and send a recruitment email about the research to those 
who meet eligibility criteria. Seven days later, the program’s HWC will call the patient to tell 
them about the research study and ask if they are interested to particpate. The HWC will make 
it clear that the patient can participate in the program without participating in the research. If 
the patient is interested in participating in the research, the HWC will verify that the patient has 
access to a mobile device with a data plan to complete the study surveys. The coach will then 
schedule the informed consent with those who have appropriate access.
Consent Process
The consent process begins when the HWC first calls the potential participant and explains the 
study to them. Interested individuals will schedule a time to meet with the coach or other 
research staff via telehealth or in person, depending on patient preference and availability, for 
consent. Potential participants will receive a copy of the informed consent form ahead of time 
by mail or email and be asked to read it carefully. At the scheduled time via telehealth, the 
research staff will present the consent form in detail, making sure the participant understands 
the research by encouraging them to ask any questions they may have, and asking them to 
explain what the study will involve in their own words. The participant a will be given sufficient 
time to read the informed consent form and the opportunity to ask questions. The patient will 
be informed that acceptance or refusal to participate in the research will not influence their 

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 4 of 9
ability to receive clinical care, or to participate in the program, and that they are free to 
withdraw from study participation at any time. Once all of the patient’s questions are 
answered, they will sign an electronic version of the consent form in REDCap, either on their 
own device or on a study iPad.
For consents conducted via telehealth, research staff will confirm the identity of the patient 
before signing the consent. Potential participants will confirm their identity by showing his/her 
driver’s license or, if not available, any state or government-issued picture identification card. If 
they do not have picture identification available, they will be asked to provide the last four 
digits of the social security number, their date of birth and one of the following: account 
number, street address, insurance carrier name, insurance policy number, medical record 
number, birth certificate or insurance card.
Immediately following the consent, the research staff will send participants a REDCap link to 
complete the demographics form to be completed on the participant’s own device or on the 
study iPad. The remaining baseline surveys will also be sent at this time if the first session is 
scheduled for within two weeks of the consent appointment. Otherwise the link to the 
remaining baseline surveys will be sent when it is within two weeks of Session 1.
Intervention Delivery
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 take place 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.
The following are the topics for each of the 8 weekly sessions:
Week
Type of Session
Topic
1 
Shared Medical 
Appointment (SMA) 
“NOURISH” with Nutrition experiential and cooking demo. 
2 
Health and Wellness 
Coaching (HWC) 
Implement “NOURISH” education into patient’s personal life. 
3 
SMA 
“MOVE” with Yoga experiential and exercise discussion. 
4 
HWC 
Implement “MOVE” education into patient’s personal life. 
5 
SMA 
“REST” with Meditation experiential and sleep discussion. 
6 
HWC 
Implement “REST” education into patient’s personal life. 
7 
SMA 
“INTEGRATE” with Acupuncture experiential and supplement 
discussion. 

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 5 of 9
8 
HWC 
Implement “INTEGRATE” education into patient’s personal life. 
Participation in the program is not contingent 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.
Data Collection
Data will be collected at baseline, 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, wellbeing, 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 conduct a review of 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. This data will 
be entered into REDCap.  
6. Study Timeline
7. Data to be Collected for Your Study 
(AFTER consent and HIPAA Authorization have been obtained)
We will collect pre-post outcome measures and satisfaction survey data. Please see attached 
surveys to be administered.  We will also collect the following from the EHR:

Age

Sex
Consent
Demographics
Baseline
4 
Week
Pre- & Post 
sessions
Between 
Sessions/After 
Session 8
8 
Week
Estimated 
time 
requirement of 
visit
30-45 
min
2-3 min
10-15 
min
8-10 
min
Pre: 1 min x 8
Post: 2 min x 7, 
6-8 min x 1
4-6 min x 8
8-10 
min
Data 
Collection
X
X
X
X
X
X

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 6 of 9

History of mental health dx 

History of use Integrative Health and Medicine services

Fertility diagnosis

BMI

Common comorbidities, including:
o
Hypertension 
o
Diabetes
o
Obesity
o
Ischemic heart disease

Pregnancy as confirmed by presence of human chorionic gonadotropin (hCG) within 6 
months of program completion
Attendance data about participants will also be collected.
8. Data Analysis Plan
Acceptability
Patients’ responses on the satisfaction survey will be assessed using descriptive statistics.
Feasibility of Study Recruitment and Retention 
We will use counts and percentages to summarize recruitment rates (#enrolled/#approached) 
and pace of accrual for the study, as well as retention rates of study participants 
(#attended/#enrolled) at each program session.
Demographics and clinical characteristics
We will use descriptive statistics (e.g. means, standard deviations, counts, and percentages) to 
summarize demographics (e.g., education level, age, income) and clinical characteristics (e.g., 
fertility-related diagnoses and duration of fertility treatment). 
Effects on patient-reported outcomes
Descriptive statistics (e.g. means, standard deviations, counts, and percentages) will be 
generated for (1) patient-reported outcomes (PRO) collected at baseline, 4 weeks and 8 weeks 
(2) pre-and post-session NRS measures; and (3) responses to the health behavior survey. We 
will use linear mixed effects models to assess changes in quantitative measures of perceived 
stress, sleep disturbance, and self-efficacy over the course of the program. Means and 
bootstrapped 95% CI will be used to assess single-session effects on numeric rating scale 
measures of stress, energy, focus, and wellbeing. All statistical analyses will be conducted using 
R and RStudio.
Data Completeness
Data collected via REDCap at each time point will be evaluated for quality and completeness 
using reporting functions within REDCap.

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 7 of 9
9. Risks to Research Participants
Some of the questions might make participants feel uncomfortable. They may skip any 
questions that they may find upsetting. 
There is a slight risk to losing privacy and confidentiality. All paper records will be kept in locked 
file cabinets and all electronic data will be stored in a password protected database to which 
only study staff will have access.
10. Provisions to Protect the Privacy Interests of Research Participants
Privacy will be ensured by conducting all study related interactions, including the consent 
process, within the private spaces, whether that is in person at the UH CWH clinic or remotely. 
Confidentiality of the research data will be protected in several ways. Any paper study 
documents will be stored in locked cabinets within the locked research offices of the PI and/or 
study staff.  Participants will be identified by a separate study ID number on all study records. 
The lists that link study ID codes with participant names, and all electronic study records will be 
stored on password-protected, encrypted computers or secure servers. Only aggregate data 
will be presented or published, and will be presented such that individuals cannot be identified. 
Only IRB approved study personnel will have access to participant data. All study personnel will 
be required to be certified in the protection of human subjects throughout the study.
Identifiable information will not be reused or disclosed to any person or entity outside of 
University Hospitals other than those identified in the protocol, except as required by law, for 
authorized oversight of the research study, or as specifically approved for use in another study 
by the IRB.
11. Potential Benefit to Research Participants
There is no guarantee of benefits to any participant in the outcome evaluation, but the 
knowledge gained may be of benefit to future fertility patients who participate in the program. 
 
12.Withdrawal of Research Participants
The study PI can withdraw participation of research participants at any time without their 
consent for the following reasons:
•
If the subject fails to follow directions for participating in the study;
•
If it is discovered that the subject does not meet the study requirements;
•
If the study is canceled; or 
•
For administrative reasons, including competitive enrollment - the target number of 
subjects has entered the study.

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 8 of 9
13. Alternatives to Participation
The only alternative to participation in the research is to not participate. Patients can 
participate in the Lifestyle Care for Fertility program regardless of participation in the research.
14. Drugs or Devices
NA
15. Additional Information
NA
16. Community-Based Participatory Research
NA 
17. International information
NA  
18. References   
1.
Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors and reproductive health: taking 
control of your fertility. Reprod Biol Endocrinol. 2013 Jul 16;11:66. doi: 10.1186/1477-7827-11-
66. PMID: 23870423; PMCID: PMC3717046.
2.
Hasanpoor-Azghdy SB, Simbar M, Vedadhir A. The emotional-psychological consequences of 
infertility among infertile women seeking treatment: Results of a qualitative study. Iran J Reprod 
Med. 2014 Feb;12(2):131-8. PMID: 24799871; PMCID: PMC4009564.
3.
Emokpae MA, Brown SI. Effects of lifestyle factors on fertility: practical recommendations for 
modification. Reprod Fertil. 2021 Jan 8;2(1):R13-R26. doi: 10.1530/RAF-20-0046. PMID: 
35128442; PMCID: PMC8812443.
4.
Fabozzi G, Verdone G, Allori M, Cimadomo D, Tatone C, Stuppia L, Franzago M, Ubaldi N, 
Vaiarelli A, Ubaldi FM, Rienzi L, Gennarelli G. Personalized Nutrition in the Management of 
Female Infertility: New Insights on Chronic Low-Grade Inflammation. Nutrients. 2022 May 
3;14(9):1918. doi: 10.3390/nu14091918. PMID: 35565885; PMCID: PMC9105997.
5.
Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors and reproductive health: taking 
control of your fertility. Reprod Biol Endocrinol. 2013 Jul 16;11:66. doi: 10.1186/1477-7827-11-
66. PMID: 23870423; PMCID: PMC3717046.
6.
Rippe JM. Lifestyle Medicine: The Health Promoting Power of Daily Habits and Practices. Am J 
Lifestyle Med. 2018 Jul 20;12(6):499-512. doi: 10.1177/1559827618785554. PMID: 30783405; 
PMCID: PMC6367881.
7.
Sforzo GA, Kaye MP, Harenberg S, Costello K, Cobus-Kuo L, Rauff E, Edman JS, Frates E, Moore 
M. Compendium of Health and Wellness Coaching: 2019 Addendum. Am J Lifestyle Med. 2019 
May 26;14(2):155-168. doi: 10.1177/1559827619850489. PMID: 32231482; PMCID: 
PMC7092405.
8.
Helena J Teede, Marie L Misso, Michael F Costello, Anuja Dokras, Joop Laven, Lisa Moran, Terhi 
Piltonen, Robert J Norman, International PCOS Network , Recommendations from the 
international evidence-based guideline for the assessment and management of polycystic ovary 

HRP-
503BIO
TEMPLATE: UH Biomedical Protocol
Approved:
12/2022
Prior Version: 
09/2021
v1 12.20.2023
Page 9 of 9
syndrome, Human Reproduction, Volume 33, Issue 9, September 2018, Pages 1602-
1618, https://doi.org/10.1093/humrep/dey256