Co-created self-care and support intervention for women with gestational diabetes in Vietnam
Living Together With Chronic Disease: Informal Support for Diabetes Management in Vietnam (VALID) - Gestational Diabetes in Vietnam - Phase II
This study is testing a new self-care and support program for pregnant women in Vietnam with gestational diabetes to see if it helps them manage their condition better and improve health for both mothers and babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Thai Binh University of Medicine and Pharmacy Academic / other |
| Locations | 2 sites (Thai Binh and 1 other locations) |
| Trial ID | NCT05744856 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on addressing gestational diabetes mellitus (GDM) among pregnant women in Vietnam, particularly in Thai Binh province. The study aims to determine the prevalence and risk factors for GDM, assess its impact on pregnancy outcomes, and understand how women and their families manage the condition. By co-creating a self-care intervention that incorporates informal support, the study seeks to enhance adherence to management guidelines and improve maternal and neonatal health outcomes. The methodology includes a pilot parallel non-randomized intervention with a delayed-start for the intervention group, involving questionnaires and glucose tolerance tests.
Who should consider this trial
Good fit: Ideal candidates are pregnant women under 28 weeks gestation residing in Thai Binh province who can read and speak Vietnamese.
Not a fit: Patients with pre-gestational diabetes or severe chronic diseases may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve self-care practices and health outcomes for pregnant women with GDM in Vietnam.
How similar studies have performed: While similar interventions have been explored, this specific approach focusing on co-created self-care in a low-and-middle-income country context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnancy \< 28 weeks * Singleton and multiple pregnancies * Residing in Thai Binh province * Speaks and reads Vietnamese * Agree to participate voluntarily (informed consent) Exclusion Criteria: * Pre-gestational diabetes (type I or type II) * Severe chronic disease Women with GDM in a prior pregnancy are eligible for inclusion into the study.
Where this trial is running
Thai Binh and 1 other locations
- Thai Binh Maternity Hospital — Thai Binh, Vietnam (Recruiting)
- Kim Ngan Clinic — Thái Bình, Vietnam (Recruiting)
Study contacts
- Principal investigator: Thanh Duc Nugyen, MD — Thain Binh Medical University
- Study coordinator: Thanh Duc Nguyen, MD
- Email: bsthanh@hotmail.com
- Phone: +84 091 235 7575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.