Gestational Diabetes and Perinatal Depression: an Intervention Program

NCT ID: NCT05800509

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2024-07-31

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 primiparous 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.

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 primiparous 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.

Conditions

Gestational Diabetes Mellitus; Postpartum Depression; Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Clips Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: SHAM_COMPARATOR

Structured Questionnaire Only

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1. The diagnosis of gestational diabetes mellitus.
• 2. The primiparous women.
• 3. 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.)
• 4. No recurrent pregnancy loss and stable condition in the first trimester of pregnancy.
• 5. Using smart phone.
• 6. Being willing to participate in this study.

Exclusion Criteria

• 1. No diagnosis of diabetes mellitus before pregnancy.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: collaborator

Taiwan Adventist Hospital

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

HUNG-HUI CHEN

Role: CONTACT

hunghuichen@ntu.edu.tw

011-886-2-2312-3456 ext. 288901

Other Identifiers

202103014RINC

Identifier Type: -

Identifier Source: org_study_id