Gestational Diabetes and Perinatal Depression: an Intervention Program

Gestational Diabetes and Depression in Pregnancy and the Postpartum Period Among Women: A Longitudinal Study and Interventive Program

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression; Gestational Diabetes Mellitus; Perinatal Depression
• Intervention / Treatment: Behavioral: Clips Intervention; Device: Structured Questionnaire Only

Detailed Description

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.

Method: The researchers will explain the purpose, procedure, and informed-consent of this study, then informed-consent form will be signed, and the structured questionnaire at 22nd week of pregnancy (including 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) will be given to fill out. The participants will be needed to record the value and date and time of blood sugar, and the picture of meals and snacks. After the first questionnaire is received from participants and their partners, 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 of experimental group will be given. However, the participants and their partner of controlled group only receive a website of health education of gestational diabetes mellitus without any clips of health education. Afterward, structured questionnaire will be also given to the participants and their partners at 35th week of pregnancy, 3rd month and 6th months after delivery.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HUNG-HUI CHEN; Phone Number: 886-2-2394-7109; Email: hunghuichen@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; 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.
Sham Comparator: Controlled group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Mackay Memorial Hospital; Taipei Veterans General Hospital, Taiwan; Taiwan Adventist Hospital; Dianthus MFM Clinics
• Investigators: Principal Investigator: HUNG-HUI CHEN, National Taiwan University Hostiptal

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Postpartum Depression; Perinatal Depression; Gestational Diabetes Mellitus; Antepartum Depression; Health Interventions
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Mood Disorders; Puerperal Disorders; Depressive Disorder; Nutritional and Metabolic Diseases; Diabetes, Gestational; Depression, Postpartum
• Other Study ID Numbers: 202103014RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No