Development of Intervention for Women After Gestational Diabetes or Pre-eclampsia

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ClinicalTrials.gov Identifier: NCT04716244

Recruitment Status : Recruiting

First Posted : January 20, 2021

Last Update Posted : January 22, 2021

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Sponsor:

Information provided by (Responsible Party):

Donna R Zwas, Hadassah Medical Organization

Study Description

Brief 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

Condition or disease	Intervention/treatment
Pre-Eclampsia Gestational Diabetes	Other: interview/focus group/questionnaire

Show detailed description

Detailed 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 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:

Total impression - from chaos to themes
Identifying and sorting meanings units - from themes to codes
Condensation - from code to meaning
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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Official Title:	Development of Health Promotion Intervention for Women With Preeclampsia and/or Gestational Diabetes Mellitus
Actual Study Start Date :	January 20, 2021
Estimated Primary Completion Date :	January 2022
Estimated Study Completion Date :	July 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gestational diabetes Preeclampsia

Genetic and Rare Diseases Information Center resources: Eclampsia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Gestational diabetes Women who were diagnosed with gestational diabetes within the least year	Other: interview/focus group/questionnaire Prior to the meetings, participants will be asked to fill in a questionnaire with demographic data including age, family status, number of pregnancies, number of children, education, and employment, history of preeclampsia or GDM, family history of CVD, and self-reported height and weight We will conduct up to 8 groups or until we 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. We will conduct up to 36 in-depth interviews. The expected duration of each interview will last 30 minutes to -1.5 hours. Participants will be asked for their consent to record the meetings, audio only. The discussions will be then transcribed. An interview guide will be followed.
Pre-eclampsia Women who were diagnosed with pre-eclampsia within the past year	Other: interview/focus group/questionnaire Prior to the meetings, participants will be asked to fill in a questionnaire with demographic data including age, family status, number of pregnancies, number of children, education, and employment, history of preeclampsia or GDM, family history of CVD, and self-reported height and weight We will conduct up to 8 groups or until we 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. We will conduct up to 36 in-depth interviews. The expected duration of each interview will last 30 minutes to -1.5 hours. Participants will be asked for their consent to record the meetings, audio only. The discussions will be then transcribed. An interview guide will be followed.

Group/Cohort

Intervention/treatment

Gestational diabetes

Women who were diagnosed with gestational diabetes within the least year

Other: interview/focus group/questionnaire

Prior to the meetings, participants will be asked to fill in a questionnaire with demographic data including age, family status, number of pregnancies, number of children, education, and employment, history of preeclampsia or GDM, family history of CVD, and self-reported height and weight We will conduct up to 8 groups or until we 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.

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

Participants will be asked for their consent to record the meetings, audio only. The discussions will be then transcribed. An interview guide will be followed.

Pre-eclampsia

Women who were diagnosed with pre-eclampsia within the past year

Other: interview/focus group/questionnaire

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

Participants will be asked for their consent to record the meetings, audio only. The discussions will be then transcribed. An interview guide will be followed.

Outcome Measures

Primary Outcome Measures :

Identification of four consistent themes on thematic qualitative analysis [ Time Frame: 12 months ]
Themes are general propositions that emerge from diverse and detail-rich experiences of participants and provide recurrent and unifying ideas regarding the subject of inquiry. Themes evolve from the conceptual codes and subcodes as in the case of taxonomy and also from the relationship codes, which tag data that link concepts to each other.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Patients who identify as female and who have given birth.
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women within 12 months of gestational diabetes or pre-eclampsia

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716244

Contacts

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Contact: Dvora Berdah, MPH	972-54-5232580	deborahb@hadassah.org.il
Contact: Donna Zwas, MD MPH	972504048274	donnaz1818@gmail.com

Locations

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Israel
Hadassah Medical Center	Recruiting
Jerusalem, Please Select An Option Below, Israel, 91120
Contact: Deborah Berda, MPH 0524855330 DeborahB@hadassah.org.il
Contact: Donna Zwas, MD MPH 0504048274 donnaz1818@gmail.com

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

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Principal Investigator:	Donna Zwas, MD MPH	Hadassah Medical Organization

More Information

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Responsible Party:	Donna R Zwas, Senior Cardiologist, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT04716244
Other Study ID Numbers:	HMO 0858-20
First Posted:	January 20, 2021 Key Record Dates
Last Update Posted:	January 22, 2021
Last Verified:	January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	Given the confidential nature of personal interviews, the de-identified thematic analysis will be made available on request of investigators with active GCP

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Donna R Zwas, Hadassah Medical Organization:


Pre-eclampsia Gestational diabetes prevention	health promotion qualitative intervention-design

Additional relevant MeSH terms:

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Diabetes, Gestational Eclampsia Pre-Eclampsia Diabetes Mellitus Glucose Metabolism Disorders	Metabolic Diseases Endocrine System Diseases Pregnancy Complications Hypertension, Pregnancy-Induced

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