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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
Sponsor:
Information provided by (Responsible Party):
Donna R Zwas, Hadassah Medical Organization

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

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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


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.





Primary Outcome Measures :
  1. 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.



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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.


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
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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