Recruiting

Gestational Diabetes and Perinatal Depression: an Intervention Program

ClinicalTrials.gov IDNCT05800509

PhaseNA

Enrollment600

SponsorNational Taiwan University Hospital

Age20 Years and older

SexALL

I'm interested View official listing

Conditions studied

Gestational Diabetes Mellitus, Postpartum Depression, Perinatal Depression

About this study

Background: The gestational diabetes mellitus and perinatal depression are both global public health issues with high prevalence. Non-perinatal diabetes mellitus and depression are confirmed to have reciprocal influence, which is bidirectional relationship. However, there are still no any confirmations of relationship in the perinatal period. The reason could be that these kinds of studies mostly had been done for postpartum depression, they had rarely been discussed with a clearly sequential influence between gestational diabetes mellitus and perinatal depression. Additionally, there have not been so many Asian countries which been done this kind of studies, therefore, this study will focus on the relationship of gestational diabetes mellitus and perinatal depression. Purpose: This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression. In the other words, the prenatal depression influences on gestational diabetes mellitus, and vice versa. Those changeable factors, such as social support, health behavior, prenatal body index, weight gain during pregnancy, perinatal complications…etc, will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depression.Afterwards, a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior, then depression and other obstetrics and gynecological results will be tested for effects.

Interventions

Behavioral: Clips Intervention — A website of health education of gestational diabetes mellitus with several short clips of health education (maternity management/counseling, healthy lifestyles, partner support...etc) for participants and their partners will be given right after the questionnaire of 22nd week of pregnancy received from the participants and their partners. There are pretest and posttest questions on the structured questionnaires of 22nd week and 35th week of pregnancy and 3rd month after delivery.
Device: Structured Questionnaire Only — A website of health education about gestational diabetes mellitus will be given to participants and their partners, then structured questionnaires and regular health service from the hospital continue to be given.

Primary outcomes

Number and percentage of participants with interventional health education as accessed by the questionnaire of EPDS change from baseline within the period from 22nd week of pregnancy to 6 months after delivery. (From 22nd week of pregnancy to 6 months after delivery.)
Number and percentage of participants with interventional health education as accessed by the self-drafted questionnaire of social support change from baseline within the period from 22nd week of pregnancy to 6 months after delivery. (From 22nd week of pregnancy to 6 months after delivery.)
Number and percentage of participants with interventional health education as accessed by the questionnaire of PPAQ change from baseline within the period from 22nd week of pregnancy to 6 months after delivery. (From 22nd week of pregnancy to 6 months after delivery.)
Number and percentage of participants with interventional health education as accessed by the self-drafted questionnaire of habit of diet change from baseline within the period from 22nd week of pregnancy to 6 months after delivery. (From 22nd week of pregnancy to 6 months after delivery.)
Number and percentage of participants with interventional health education as accessed by the medical record of maternal body weight in kilograms change from baseline of pre-pregnancy within the 6 months after delivery. (From 22nd week of pregnancy to 6 months after delivery.)
Number and percentage of participants with interventional health education as accessed by the medical record of maternal BMI in kg/m^2 change from baseline of pre-pregnancy within the 6 months after delivery. (From 22nd week of pregnancy to 6 months after delivery.)
Number and percentage of participants with interventional health education as accessed by the questionnaire of knowledge and self-management of gestational diabetes mellitus change from baseline from 22nd week of pregnancy to 6 months after delivery. (From 22nd week of pregnancy to 6 months after delivery.)
Number and percentage of participants with interventional health education as accessed by the self-drafted questionnaire of health belief change from baseline within the period from 22nd week of pregnancy to 6 months after delivery. (From 22nd week of pregnancy to 6 months after delivery.)

Eligibility information

Inclusion Criteria: * 1\. The diagnosis of gestational diabetes mellitus. * 2\. No any history of disease\* before the pregnancy or do have history of disease\* without taking any medicines. (\*disease, eg. hypertension, diabetes mellitus, hyperthyroidism...etc.) * 3\. No recurrent pregnancy loss and stable condition in the first trimester of pregnancy. * 4\. Using smart phone. * 5\. Being willing to participate in this study. Exclusion Criteria: \- 1. No diagnosis of diabetes mellitus before pregnancy.

Study locations

National Taiwan University Hospital, Taipei, 100 Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-27.