Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)
Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
연구 개요
상태
정황
상세 설명
Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Turin, 이탈리아, 10126
- University of Turin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Gestational age between 24 and 26 weeks
- Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
- Singleton pregnancy
Exclusion Criteria:
- Body mass index > 40 or < 12kg/m2
- Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
- Patients on any drugs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 연습
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The exercise groups will be advised to walk at least 20-minute a day.
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간섭 없음: Diet alone
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실험적: Behavioral therapy
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General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out.
A brief written guide on behavior change.
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실험적: Behavioral therapy and exercise
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General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. Written recommendations for physical activity A brief written guide on behavior change |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Serum fasting glucose values.
기간: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
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To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.
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Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Serum fasting insulin values
기간: At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
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To investigate changes from baseline in serum fasting insulin values in each arm.
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At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
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The need for insulin therapy
기간: At recruitment and at the end of follow-up (38 weeks)
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The need for insulin therapy in each arm
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At recruitment and at the end of follow-up (38 weeks)
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The number of Cesarean sections
기간: From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
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The number of Cesarean sections in each arm
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From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks
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The mean birth-weight of newborns
기간: From recruitment until the date of delivery, assessed up to 42 weeks
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The mean birth-weight of newborns in each arm
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From recruitment until the date of delivery, assessed up to 42 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- sbo2010
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