Development of Intervention for Women After Gestational Diabetes or Pre-eclampsia
Development of Intervention for Women After Gestational Diabetes or Pre-eclampsia
Our objectives in this qualitative exploratory study:

 -  To explore the perspectives and preferences of women with preeclampsia and/or GDM
 history related to a potential health promotion program

 -  To identify perception of support services post-birth related to health behaviors

 -  To identify perception of personal and children's risk of future health issues related
 to GDM and preeclampsia history

 -  To explore effective intervention strategies and approaches for potential intervention

 -  To identify barriers and facilitators to adoption and adherence to healthy lifestyles
 changes in women with preeclampsia and/or GDM history

 -  Based on our results, literature review and counselling by a panel of health promotion
 experts, the investigators will design protocol and guidelines for a future
 interventional health promotion programs

 Methods:

 Study Design The proposed study consists of a qualitative exploratory study in different
 populations of women who underwent gestational diabetes or pre-eclampsia
This study aims to explore experiences, views and concerns of women with history of
 preeclampsia and/or GDM and gain in-depth understanding of the factors that would motivate or
 deter adoption and adherence to healthy lifestyle and prevention of CVD.

 Our objectives in this qualitative exploratory study:

 -  To explore the perspectives and preferences of women with preeclampsia and/or GDM
 history related to a potential health promotion program

 -  To identify perception of support services post-birth related to health behaviors

 -  To identify perception of personal and children's risk of future health issues related
 to GDM and preeclampsia history

 -  To explore effective intervention strategies and approaches for potential intervention

 -  To identify barriers and facilitators to adoption and adherence to healthy lifestyles
 changes in women with preeclampsia and/or GDM history

 -  Based on our results, literature review and counselling by a panel of health promotion
 experts the investigators will design protocol and guidelines for a future
 interventional health promotion programs

 Methods:

 Study Design The proposed study consists of a qualitative exploratory study.

 Recruitment Women aged 18-50 years following a pregnancy where they were diagnosed with
 preeclampsia and/or GDM will participate in this study.

 Recruitment site 1: the investigators will conduct focus groups in Hebrew and Arabic with
 women after preeclampsia and/or GDM who gave birth in the Hadassah medical center or are
 participating in the Hadassah postpartum clinic for patients with complicated pregnancies.
 Separate focus groups will be conducted for women with prior preeclampsia and for women with
 GDM history.

 The eligible women will be approached by the study investigator and will be informed about
 the study. The interested women will be recruited to participate in this study and will be
 asked to sign a consent form.

 Those not able to participate in focus groups will be invited to share their experience
 through in-depth interviews.

 Given the restrictions imposed by the Covid-19 pandemic, as well as the evidence about the
 difficulty among post-partum women to attend face-to-face interviews50, participants will be
 offered to participate in either on-site, face to face interviews in Hadassah or
 teleconference-based interviews (by phone or secured online meeting forms such as zoom
 meetings).

 The investigators will ensure that the face to face groups/ interviews will be conducted in
 accordance with the physical-distancing instructions of the ministry of health due to
 Covid-19 pandemic.

 The women will be contacted by the research team within 1 year from discharge. The
 investigators will contact them through the phone or e-mail to plan their participation in
 the focus groups/ in depth interviews. The interviews will take place within 12 months from
 the discharge.

 Recruitment site 2: the investigators will recruit ultra-Orthodox (Haredi) through community
 centers from different neighborhoods in Jerusalem.

 Invitation to participate in the interviews will be published using posters and/or direct
 contact with the women by the community-center's staff. The investigators will recruit women
 that participate in post-partum mothers' programs through community centers, in the Haredi
 neighborhoods. The eligible and interested women will be recruited to participate in the
 study and will be asked to sign a consent form prior to the interview. The women will sign
 consent before the meetings or phone consent for teleconference/ phone meetings.

 Inclusion criteria/ Exclusion criteria

 The investigators will recruit women:

 -  Who gave birth in Hadassah medical center, Jerusalem (within 12 months of a live birth)
 or participating to the Hadassah postpartum clinic for patients with complicated
 pregnancies

 -  After a pregnancy where women were diagnosed with preeclampsia and/or GDM (diagnosed)
 within 12 months post-partum

 -  Between 18 and 50 years old

 -  That will be able to communicate in Hebrew or Arabic

 In the community centers, the investigators will recruit women:

 -  After a pregnancy where women were diagnosed with preeclampsia and/or GDM (diagnosed)
 within 12 months of a live birth

 -  Between 18 and 50 years old

 -  That will be able to communicate in Hebrew or Arabic The investigators will exclude
 women with serious complications of preeclampsia and or/GDM as perinatal mortality or
 multi-organ failure.

 Quantitative component:

 Prior to the meetings, participants will be asked to fill in a questionnaire (will take
 approximately 10 minutes) . The questionnaire consists on the following sections:

 Demographic data including age, family status, number of pregnancies, number of children,
 education, and employment History of disease: preeclampsia or GDM, family history of CVD Self
 -reported height and weight

 Participants, who will be interviewed through tele-conference, will receive the questionnaire
 through electronically and will be asked to fill it prior to the interview. The questionnaire
 will be filled out using a participant ID which is de-identified, and will be collected
 through the Nemala system which is encrypted and secure according to Ministry of Health and
 Helsinki committee recommendations. Participants who will be unable to fill in electronically
 (Haredi population) will complete the questionnaire by phone. For on-site and face to face
 interviews, participants will be administered a print copy or the online questionnaire using
 a computer or tablet, using the de-identified participant identification, and will be asked
 to fill it prior to the interview.

 Number of participants - up to 100 Focus group discussions: the investigators will conduct up
 to 8 groups or until the investigators reach saturation of themes. For the teleconference
 focus groups, the number of participants will be limited to 6 women per group, as recommended
 from previous research on teleconference focus groups51. The face to face focus groups will
 include up to -12 women. The expected duration of each group, will last 1-2 hours.

 In-depth interviews: The investigators will conduct up to 36 in-depth interviews. The
 expected duration of each interview will last 30 minutes to -1.5 hours.

 The investigators will recruit up to 100 women in total for focus groups and in-depth
 interviews. Each participant will be interviewed only once, in a focus group or in-depth
 interview, depending on her preference.

 Prior to the interviews, the interviewer will explain again the purpose of the study.
 Interviews will be conducted by researchers from the Linda Joy Pollin center who have a
 previous experience conducting qualitative studies.

 Participants will be asked for their consent to record the meetings, audio only. The
 discussions will be then transcribed without any identification information of the
 participants and the recordings will be destroyed afterwards. An interview guide was prepared
 by the research staff (see attached the interview guides- for focus groups and in-depth
 interviews).

 To maintain confidentiality, the investigators will use first names only during the face to
 face/ online meeting forms -zoom meetings.

 Data analysis

 Focus groups and in-depth interviews will be recorded, transcribed and analyzed by
 investigator according to a thematic analysis:

 1. Total impression - from chaos to themes

 2. Identifying and sorting meanings units - from themes to codes

 3. Condensation - from code to meaning

 4. Synthesizing - from condensation to descriptions and concepts

 Data Storage In order to maintain confidentiality, all paper data will be stored in a double
 locked storage space at Hadassah hospital. No identifying information will be collected on
 the data itself (either electronic or paper), aside from a coding number. Any documentation
 of focus groups/ in-depth interviews outcomes will not include identifying information.
Inclusion Criteria:

 -  women:

 -  within 12 months of a live birth

 -  After a pregnancy where women were diagnosed with preeclampsia and/or GDM
 (diagnosed) within 12 months post-partum

 -  Between 18 and 50 years old

 Exclusion Criteria:

 - We will exclude women with serious complications of preeclampsia and or/GDM as perinatal
 mortality or multi-organ failure.