Clinical trial NCT05800509: Gestational Diabetes and Perinatal Depression: an Intervention Program
Official title: Gestational Diabetes and Depression in Pregnancy and the Postpartum Period Among Primipara Women: A Longitudinal Study and Interventive Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Postpartum Depression
Perinatal Depression
Keywords: Antepartum Depression
Gestational Diabetes Mellitus
Perinatal Depression
Postpartum Depression
Health Interventions
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Mackay Memorial Hospital
name: Taiwan Adventist Hospital
name: Taipei Veterans General Hospital, Taiwan
First posted: 2023-04-05
Enrollment: 226
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 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.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: 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.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: 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.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: 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.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: 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.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: 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.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: 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.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: 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.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: Number and percentage of participants with interventional health education as accessed by the medical record of their perinatal complications.
timeFrame: From 22nd week of pregnancy to 6 months after delivery.
measure: Number and percentage of participants with interventional health education as accessed by the medical record of their infants' body weight in kilograms.
timeFrame: Within 6 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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