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

NCT04716244 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

  • Pre-Eclampsia
  • Gestational Diabetes

Interventions

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.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Donna Zwas, MD MPH · Hadassah Medical Organization

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2025-01-01
Completion
2025-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04716244 on ClinicalTrials.gov