Gestational Diabetes and Perinatal Depression: an Intervention Program

Study Overview
=================
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.

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

Conditions
-----------------
Gestational Diabetes Mellitus, Postpartum Depression, Perinatal Depression

Intervention / Treatment
-----------------
* Behavioral: Clips Intervention
* Device: Structured Questionnaire Only


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* 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.<br>|
| Sham Comparator: Controlled group<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antepartum Depression, Gestational Diabetes Mellitus, Perinatal Depression, Postpartum Depression, Health Interventions