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

NCT04716244 | Unknown DMC

• 1 other identifier: HMO 0858-20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Identification of four consistent themes on thematic qualitative analysis

  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.

  12 months

Study Arms (2)

Gestational diabetes

Women who were diagnosed with gestational diabetes within the least year

Other: interview/focus group/questionnaire

Pre-eclampsia

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

Other: interview/focus group/questionnaire

Interventions

interview/focus group/questionnaire OTHER

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.

Gestational diabetes; Pre-eclampsia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Patients who identify as female and who have given birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women within 12 months of gestational diabetes or pre-eclampsia

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Please Select An Option Below, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Diabetes, Gestational

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Donna Zwas, MD MPH

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dvora Berdah, MPH

CONTACT

972-54-5232580; deborahb@hadassah.org.il

Donna Zwas, MD MPH

CONTACT

972504048274; donnaz1818@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Cardiologist

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 20, 2021
• Study Start: January 20, 2021
• Primary Completion: January 1, 2025
• Study Completion: July 31, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)