Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04716244 |
| Other study ID # |
HMO 0858-20 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2021 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
April 2023 |
| Source |
Hadassah Medical Organization |
| Contact |
Dvora Berdah, MPH |
| Phone |
972-54-5232580 |
| Email |
deborahb[@]hadassah.org.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Health care providers who provide care to women with gestational diabetes and pre-eclampsia
will be interviewed to explore effective intervention strategies.
Description:
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
1. Women aged 18-50 years following a pregnancy where they were diagnosed with preeclampsia
and/or GDM will participate in this study.
2. Health care providers who provide care to women with gestational diabetes and
pre-eclampsia will be interviewed to explore effective intervention strategies.
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) and Arab
participants 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
and Arab 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.
The investigators will interview health care practitioners who provided health care within
the Hadassah system and outside clinics.
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.
