Gestational Diabetes and Perinatal Depression: an Intervention Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Clips Intervention
BehavioralA 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.
Structured Questionnaire Only
DeviceA 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Controlled groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From 22nd week of pregnancy to 6 months after delivery.2
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.
Time frame
From 22nd week of pregnancy to 6 months after delivery.3
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.
Time frame
From 22nd week of pregnancy to 6 months after delivery.4
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.
Time frame
From 22nd week of pregnancy to 6 months after delivery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Mackay Memorial Hospital
Collaborator
Taiwan Adventist Hospital
Collaborator
Taipei Veterans General Hospital, Taiwan
Collaborator
Dianthus MFM Clinics
Collaborator
Source ClinicalTrials.gov