The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women
2021년 3월 2일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
120
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Sanmin Dist
-
Kaohsiung City, Sanmin Dist, 대만, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental group
The experimental group will receive the perinatal health promotion program and regular prenatal care
|
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
|
|
간섭 없음: Control group
The control group will receive the regular perinatal care
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes of biological indicator
기간: 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.
|
Fasting blood glucose test
|
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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes of maternal body weight
기간: 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.
|
Maternal body weight(weight in kilograms)
|
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.
|
|
Changes of maternal height
기간: 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.
|
Maternal height(height in meters)
|
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.
|
|
Changes of newborn body weight
기간: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
Newborn body weight (weight in grams)
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
|
Changes of newborn body length
기간: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
Newborn body length (length in centimeter)
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
|
Changes of newborn head circumference
기간: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
Newborn head circumference (length in centimeter)
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
|
Changes of newborn Apgar score
기간: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
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.
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
|
Health information of newborn
기간: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
The newborn's health status and complications.
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
|
Changes of diabetes management self-efficacy Scale
기간: 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.
|
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.
|
|
Changes of postpartum stress
기간: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
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.
|
|
Changes of depression
기간: 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.
|
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.
|
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.
|
|
Changes of health status
기간: 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.
|
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.
|
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.
|
|
Changes of blood pressure
기간: 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.
|
Blood pressure(with systolic, and diastolic)
|
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.
|
|
Changes of body mass index
기간: 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.
|
Body mass index (kg/m^2)
|
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.
|
|
Basic information of maternal
기간: women's six-month gestational age
|
Women's age, education, occupation, family income, marriage, pregnancy and production history
|
women's six-month gestational age
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Hsiang-Chi Yu, Master, Kaohsiung Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 1월 22일
기본 완료 (실제)
2020년 7월 31일
연구 완료 (실제)
2020년 7월 31일
연구 등록 날짜
최초 제출
2017년 12월 26일
QC 기준을 충족하는 최초 제출
2018년 10월 28일
처음 게시됨 (실제)
2018년 10월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 3월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 3월 2일
마지막으로 확인됨
2019년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .