- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03578094
Mother and Infant Study Cohort (MISC)-
Impact of Feeding Patterns on Adiposity and Cardiometabolic Markers in Baby and Mother: A Prospective Cohort Study
This study aims to explore breastfeeding and complementary feeding practices of mothers in the United Arab Emirates (UAE) and its relation to the early life determinants of obesity and non-communicable diseases (NCDs). This research study will follow a prospective cohort approach. Two hundred and fifty mother-infant pairs will be followed for 18 months.
The hypothesis of this research study is that exclusive breastfeeding of the infant will provide potential protective effect against cardiometabolic risk factors. This study will also hypothesize that mothers who exclusively breastfeed their newborns would experience greater postpartum weight and body fat loss than mothers who are not breastfeeding.
연구 개요
상태
상세 설명
United Arab Emirates(UAE) is facing two critical situations: high incidence of obesity and chronic diseases and suboptimal infant feeding practices as reported by the Ministry of Health in the UAE. So early identification of preventive markers of cardiometabolic risk factors in breast milk is important for developing early intervention strategies to optimize health care for individuals and communities especially in countries suffering from high rates of obesity and chronic diseases such as the UAE.
The purpose of this study is to prospectively follow up with the mothers and their infants (from 0-18months of infants age). It will explore breastfeeding and complementary feeding practices of mothers in UAE and its relation to the early life determinants of obesity and non-communicable diseases (NCDs). It will examine the components of human milk which might offer a protective benefit against obesity and its health consequences in infancy. It will also evaluate the feeding practices of the mothers and her nutritional status and relates it to their infants' growth and development.
It is expected that this research study will fill an important knowledge gap in the understanding of the feeding practices of mothers and its relation to early-life determinants of obesity and other chronic diseases in the UAE.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Shajah
-
Sharjah, Shajah, 아랍 에미리트, 27272
- Hadia Radwan
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The sample population is Emirati and Arab expatriate mothers, aged 19 to 40 years old; visiting Mother and Child Centers (MCH) and Primary Healthcare Centers (PHC) in Dubai and Sharjah.
The selected mothers (who will be recruited during their 3rd trimester) were invited to participate in the study after being consented for their procedures and they will sign on the behalf of their babies
설명
Inclusion Criteria:
Pregnant women:
- Emirate nationality or Arab expatriate
- Age: 19-40 years
- Singleton pregnancy
- Within the third trimester of pregnancy (27-42 weeks of gestation)
- Free of chronic diseases (diabetes, hypertension, kidney disease, cancer, or other chronic diseases), autoimmune disorders, or infections with the human immunodeficiency virus, or hepatitis in preconception
Exclusion Criteria:
- Multiple pregnancies (pregnant with two or more fetuses)
- High-risk pregnancy or pre-eclampsia
- History of chronic diseases
- Preterm (<37 weeks of gestation) or late-term (>42 weeks of gestation) infants
- Congenital diseases or any health condition that could deter breastfeeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
relationship between exclusive breastfeeding and maternal serum levels of adiponectin
기간: 18 months
|
measuring the adiponectin level in the maternal serum at 6 months postpartum
|
18 months
|
|
relationships between maternal milk levels of adiponectin with infants serum levels of adiponectin
기간: 18 months
|
measuring the adiponectin level and in the infants serum and in the breast milk
|
18 months
|
|
Comparison of the infant adiponectin serum level in exclusive breastfeeding mothers versus mothers who do not exclusively breastfeed their infants
기간: 18 months
|
measuring the adiponectin serum level in the infants of exclusive breastfeeding group and other breastfeeding patterns
|
18 months
|
|
Association between duration of breastfeeding and mothers' anthropometric measurements(weight in kilograms and Height in meters )
기간: 18 months
|
Measuring the weight in kilograms and height in meters weight and height will be combined to report BMI in kg/m^2 of the mothers at different timelines in relation to breastfeeding duration
|
18 months
|
|
Assessment of the anthropometric measurements (weight in kilograms and height in meters) of the mothers according to the breastfeeding patterns
기간: 18 months
|
Measuring the weight in kilograms and height in meters weight and height will be combined to report BMI in kg/m^2 of mothers at different timelines in relation to different breastfeeding patterns
|
18 months
|
|
relationship between exclusive breastfeeding and breast milk levels of adiponectin
기간: 18 months
|
measuring the adiponectin level in the breast milk at 6 months postpartum
|
18 months
|
|
Assessment of the anthropometric measurements of the infant according to the breastfeeding patterns
기간: 18 months
|
measuring the weight, height, mid upper arm circumference of the infant at different timelines in relation to the breastfeeding patterns
|
18 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hadia Radwan, PhD, University of Sharjah
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1501057003-P
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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