NCT05800509

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

February 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

February 7, 2023

Last Update Submit

March 19, 2026

Conditions

Perinatal DepressionGestational Diabetes MellitusPostpartum Depression

Keywords

Antepartum DepressionGestational Diabetes MellitusPerinatal DepressionPostpartum DepressionHealth Interventions

Outcome Measures

Primary Outcomes (10)

  • 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.

    Perinatal depression is measured by Edinburgh Postnatal Depression Scale (EPDS) in questionnaire.

    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.

    The social support scale is measured by self-drafted questionnaire, those questions are ranked within 5 intervals, from very insufficient to very sufficient.

    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.

    Physical activity is measured by Pregnancy Physical Activity Questionnaire (PPAQ) in questionnaire.

    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.

    The habit of diet is measured by self-drafted questionnaire, those questions are related to frequencies of diet, preferences of diet, choices of diet.

    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.

    The maternal body weight in kilograms is acquired from medical record.

    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.

    The maternal Body Mass Index (BMI) in kg/m\^2 is calculated by body weight in kilograms and height in meters, which are acquired from medical record.

    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.

    The knowledge and self-management of gestational diabetes mellitus are measured by self-drafted questionnaire, which are true/false questions.

    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.

    The health belief is measured by self-drafted questionnaire, those questions are ranked within 5 intervals, from extremely disagree to extremely agree.

    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 their perinatal complications.

    The perinatal complication is acquired from medical record

    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 their infants' body weight in kilograms.

    The infants' body weight in kilograms is acquired from medical record.

    Within 6 months after delivery

Study Arms (2)

Experimental Group

EXPERIMENTAL

The participants and their partners will receive structured questionnaires respectively at 22nd and 35th week of pregnancy, and 3rd month and 6th month after delivery. The context of questionnaire includes basic information (age, level of education and occupation of the participant and her partner, household income, and status of marriage), marriage satisfaction, obstetrics and gynecological history (history of abortion, intended pregnancy , and artificial insemination), psychiatric history, family history of diabetes mellitus, height, pre-pregnancy weight, sleeping status, and basic knowledge of gestational diabetes mellitus. 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.

Behavioral: Clips Intervention

Controlled group

SHAM COMPARATOR

The participants and their partners will receive structured questionnaires respectively at 22nd and 35th week of pregnancy, and 3rd month and 6th month after delivery. The context of questionnaire includes basic information (age, level of education and occupation of the participant and her partner, household income, and status of marriage), marriage satisfaction, obstetrics and gynecological history (history of abortion, intended pregnancy , and artificial insemination), psychiatric history, family history of diabetes mellitus, height, pre-pregnancy weight, sleeping status, and basic knowledge of gestational diabetes mellitus. A website of health education about gestational diabetes mellitus for participants and their partners will be given right after the questionnaire of 22nd week of pregnancy received from the participants and their partners.

Device: Structured Questionnaire Only

Interventions

Structured Questionnaire OnlyDEVICE

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.

Controlled group
Clips InterventionBEHAVIORAL

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.

Experimental Group

Eligibility Criteria

Age20 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPregnant women will be recruited at the hospitals, and then their partners (the role of partners as biological fathers during pregnancy) will be invited to participate this study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. The diagnosis of gestational diabetes mellitus.
  • \. 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.)
  • \. No recurrent pregnancy loss and stable condition in the first trimester of pregnancy.
  • \. Using smart phone.
  • \. Being willing to participate in this study.

You may not qualify if:

  • \- 1. No diagnosis of diabetes mellitus before pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes, GestationalDepression, Postpartum

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPuerperal DisordersDepressive DisorderMood DisordersMental Disorders

Study Officials

  • HUNG-HUI CHEN

    National Taiwan University Hostiptal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HUNG-HUI CHEN

CONTACT

886-2-2394-7109hunghuichen@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is randomized-controlled trial, half of enrolled participants acquire the intervention of health education and regular health service from hospital, another half only acquire regular health service from hospital.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

April 5, 2023

Study Start

October 26, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)