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Gestational Diabetes and Perinatal Depression: an Intervention Program

Primary Purpose

Gestational Diabetes Mellitus, Postpartum Depression, Perinatal Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clips Intervention
Structured Questionnaire Only
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gestational Diabetes Mellitus focused on measuring Antepartum Depression, Gestational Diabetes Mellitus, Perinatal Depression, Postpartum Depression, Health Interventions

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Experimental Group

    Controlled group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2023
    Last Updated
    March 23, 2023
    Sponsor
    National Taiwan University Hospital
    Collaborators
    Mackay Memorial Hospital, Taiwan Adventist Hospital, Taipei Veterans General Hospital, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05800509
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    Mackay Memorial Hospital, Taiwan Adventist Hospital, Taipei Veterans General Hospital, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes Mellitus, Postpartum Depression, Perinatal Depression
    Keywords
    Antepartum Depression, Gestational Diabetes Mellitus, Perinatal Depression, Postpartum Depression, Health Interventions

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    226 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Controlled group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Clips Intervention
    Intervention Description
    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
    Device
    Intervention Name(s)
    Structured Questionnaire Only
    Intervention Description
    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 Outcome Measure Information:
    Title
    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.
    Description
    Perinatal depression is measured by Edinburgh Postnatal Depression Scale (EPDS) in questionnaire.
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    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.
    Description
    The social support scale is measured by self-drafted questionnaire, those questions are ranked within 5 intervals, from very insufficient to very sufficient.
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    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.
    Description
    Physical activity is measured by Pregnancy Physical Activity Questionnaire (PPAQ) in questionnaire.
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    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.
    Description
    The habit of diet is measured by self-drafted questionnaire, those questions are related to frequencies of diet, preferences of diet, choices of diet.
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    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.
    Description
    The maternal body weight in kilograms is acquired from medical record.
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    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.
    Description
    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.
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    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.
    Description
    The knowledge and self-management of gestational diabetes mellitus are measured by self-drafted questionnaire, which are true/false questions.
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    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.
    Description
    The health belief is measured by self-drafted questionnaire, those questions are ranked within 5 intervals, from extremely disagree to extremely agree.
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    Number and percentage of participants with interventional health education as accessed by the medical record of their perinatal complications.
    Description
    The perinatal complication is acquired from medical record
    Time Frame
    From 22nd week of pregnancy to 6 months after delivery.
    Title
    Number and percentage of participants with interventional health education as accessed by the medical record of their infants' body weight in kilograms.
    Description
    The infants' body weight in kilograms is acquired from medical record.
    Time Frame
    Within 6 months after delivery

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Pregnant 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.
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    HUNG-HUI CHEN
    Phone
    011-886-2-2312-3456
    Ext
    288901
    Email
    hunghuichen@ntu.edu.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Gestational Diabetes and Perinatal Depression: an Intervention Program

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