The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women
2 maart 2021 bijgewerkt door: Kaohsiung Medical University Chung-Ho Memorial Hospital
The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women's Bio-psycho-social Features and Child Growth
Taiwan National Health Insurance system was launched in 1995 and the diagnosis and treatment for gestational diabetes mellitus were reimbursed.
However, controversy regarding treatment and prevention programs for the other different levels of gestational hyperglycemia continues.
Moreover, long-term follow-up studies for the impact of different levels of gestational hyperglycemia on women's perinatal consequences were not found.
Thus, the purpose of the study, is to explore the effect of a perinatal health promotion program on three different levels of gestational hyperglycemic women's bio-psycho-social features and their offspring's development.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The investigators will recruit 120 women with three different levels of gestational hyperglycemia and assign them to either experimental group (a total of 60 women of gestational hyperglycemia) or control group (a total of 60 women of gestational hyperglycemia).
Data will be collected at the women's six-month gestation, hospitalization for childbirth, and six weeks, six months, and one year postpartum.
The three-year study findings can demonstrate the consequences and risk factors for women with three different levels of gestational hyperglycemia to suffer from type 2 diabetes mellitus.
In addition, the results can be taken as an evidence-based intervention for the perinatal health promotion program in preventing the gestational hyperglycemic women to suffer from type 2 diabetes mellitus and in decreasing the impact of gestational hyperglycemia on the development of the gestational hyperglycemic women's offspring.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Sanmin Dist
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Kaohsiung City, Sanmin Dist, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:The woman who
- Is 20 years old or above.
- Has a positive test for gestational diabetes mellifluous with the 75% oral glucose tolerance test during 24~28 gestation.
- Has junior high or above educational level.
- Can speak Mandarin Chinese.
- Is Taiwanese residence.
- Plans to give a childbirth at the medical center.
Exclusion Criteria:The woman who
-Is immigrant.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Experimental group
The experimental group will receive the perinatal health promotion program and regular prenatal care
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Regular prenatal care and perinatal health promotion program including health promotion during pregnant period, health promotion during the ritual of Tso-Yueh-Tzu, health promotion during postpartum period, newborn care
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Geen tussenkomst: Control group
The control group will receive the regular perinatal care
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes of biological indicator
Tijdsspanne: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Fasting blood glucose test
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women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes of maternal body weight
Tijdsspanne: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Maternal body weight(weight in kilograms)
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women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of maternal height
Tijdsspanne: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Maternal height(height in meters)
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women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of newborn body weight
Tijdsspanne: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Newborn body weight (weight in grams)
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about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of newborn body length
Tijdsspanne: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Newborn body length (length in centimeter)
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about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of newborn head circumference
Tijdsspanne: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Newborn head circumference (length in centimeter)
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about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of newborn Apgar score
Tijdsspanne: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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The newborn Apgar score in 1 and 5 minutes.The test is generally done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low.
Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
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about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Health information of newborn
Tijdsspanne: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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The newborn's health status and complications.
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about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of diabetes management self-efficacy Scale
Tijdsspanne: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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The Diabetes Management Self-efficacy Scale(DMSES) measures the individual's efficacy expectations for engaging in 20 type 2 diabetes self-management activities (Bijl et al., 1999). The scale is scored according to a 1-5 point numerical scale indicating the level of efficacy expectation the respondent has for each item with higher scores indicating greater levels of self-efficacy. |
women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of postpartum stress
Tijdsspanne: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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The 62-item Hung Postpartum Stress Scale (Hung PSS) is a valid and reliable tool for assessing women's postpartum stress during the 42-day postpartum period. Exploratory factor analysis indicated three components of postpartum stress: concerns about maternal role attainment, body changes and lack of social support (Hung, 2007) The Cronbach's alpha of the Hung PSS was 0.95. On a five-point Likert scale rating from 1 (not at all) - 5 (always), women rated each item on how often stress was perceived during the postpartum period. The score for postpartum stress was derived by summing all ratings, resulting in potential scores between 62-310. Higher values indicated a higher level of stress. |
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of depression
Tijdsspanne: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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The 18-item Taiwanese Depression Questionnaire(TDQ) is widely used to screen for depression in Taiwan.
The TDQ is a culture-specific, self-administered questionnaire; its sensitivity and specificity have been measured as 0.89 and 0.92, respectively (Lee, Yang, Lai, Chiu, & Chau, 2000).
Using a 4-point Likert scale (i.e., 0-3), participants indicated whether and how often they experienced each item.
Total scores ranged from 0 to 54; higher scores indicated more severe depression symptoms.
The values of Cronbach's α at the five time points were .82 to .90.
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women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of health status
Tijdsspanne: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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We used the 12 items Chinese Health Questionnaire(CHQ) to measure perinatal women's health status (developed by Cheng (1985) and verified by Chong and Wilkinson (1989).
Responses used a 4-point Likert scale (1 = not at all; 4 = most of the time).
Responses of 1 or 2 were recoded as "0," responses of 3 or 4 were recoded as "1," and a total score ranging from 0 to 12 was calculated by summing the ratings (Chong & Wilkinson, 1989).
The CHQ's sensitivity and specificity have been measured as 91.9% and 66.7%, respectively (Chong & Wilkinson, 1989); in this study, values of Cronbach's α ranged from .64 to .75 at the five time points.
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women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of blood pressure
Tijdsspanne: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Blood pressure(with systolic, and diastolic)
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women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Changes of body mass index
Tijdsspanne: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Body mass index (kg/m^2)
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women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
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Basic information of maternal
Tijdsspanne: women's six-month gestational age
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Women's age, education, occupation, family income, marriage, pregnancy and production history
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women's six-month gestational age
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Hsiang-Chi Yu, Master, Kaohsiung Medical University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 januari 2018
Primaire voltooiing (Werkelijk)
31 juli 2020
Studie voltooiing (Werkelijk)
31 juli 2020
Studieregistratiedata
Eerst ingediend
26 december 2017
Eerst ingediend dat voldeed aan de QC-criteria
28 oktober 2018
Eerst geplaatst (Werkelijk)
31 oktober 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 maart 2021
Laatste update ingediend die voldeed aan QC-criteria
2 maart 2021
Laatst geverifieerd
1 april 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KMUHIRB-SV(I)-20160055
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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