Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT03578094
Status:
COMPLETED
Last Update Posted:
2018-07-05
First Post:
2018-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mother and Infant Study Cohort (MISC)-
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D000073296', 'term': 'Noncommunicable Diseases'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Breastmilk samples, blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-22', 'studyFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2018-06-22', 'lastUpdatePostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relationship between exclusive breastfeeding and maternal serum levels of adiponectin', 'timeFrame': '18 months', 'description': 'measuring the adiponectin level in the maternal serum at 6 months postpartum'}, {'measure': 'relationships between maternal milk levels of adiponectin with infants serum levels of adiponectin', 'timeFrame': '18 months', 'description': 'measuring the adiponectin level and in the infants serum and in the breast milk'}, {'measure': 'Comparison of the infant adiponectin serum level in exclusive breastfeeding mothers versus mothers who do not exclusively breastfeed their infants', 'timeFrame': '18 months', 'description': 'measuring the adiponectin serum level in the infants of exclusive breastfeeding group and other breastfeeding patterns'}, {'measure': "Association between duration of breastfeeding and mothers' anthropometric measurements(weight in kilograms and Height in meters )", 'timeFrame': '18 months', 'description': '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'}, {'measure': 'Assessment of the anthropometric measurements (weight in kilograms and height in meters) of the mothers according to the breastfeeding patterns', 'timeFrame': '18 months', 'description': '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'}, {'measure': 'relationship between exclusive breastfeeding and breast milk levels of adiponectin', 'timeFrame': '18 months', 'description': 'measuring the adiponectin level in the breast milk at 6 months postpartum'}, {'measure': 'Assessment of the anthropometric measurements of the infant according to the breastfeeding patterns', 'timeFrame': '18 months', 'description': 'measuring the weight, height, mid upper arm circumference of the infant at different timelines in relation to the breastfeeding patterns'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cohort', 'Noncommunicable diseases', 'pregnancy', 'infant', 'cognition', 'United Arab Emirates', 'gestational diabetes'], 'conditions': ['Adiposity, Breast Feeding']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "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.\n\nThe 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.\n\nIt 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nThe 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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women:\n\n * Emirate nationality or Arab expatriate\n * Age: 19-40 years\n * Singleton pregnancy\n * Within the third trimester of pregnancy (27-42 weeks of gestation)\n * 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\n\nExclusion Criteria:\n\n* Multiple pregnancies (pregnant with two or more fetuses)\n* High-risk pregnancy or pre-eclampsia\n* History of chronic diseases\n* Preterm (\\<37 weeks of gestation) or late-term (\\>42 weeks of gestation) infants\n* Congenital diseases or any health condition that could deter breastfeeding'}, 'identificationModule': {'nctId': 'NCT03578094', 'briefTitle': 'Mother and Infant Study Cohort (MISC)-', 'organization': {'class': 'OTHER', 'fullName': 'University of Sharjah'}, 'officialTitle': 'Impact of Feeding Patterns on Adiposity and Cardiometabolic Markers in Baby and Mother: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '1501057003-P'}}, 'contactsLocationsModule': {'locations': [{'zip': '27272', 'city': 'Sharjah city', 'state': 'Shajah', 'country': 'United Arab Emirates', 'facility': 'Hadia Radwan', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}], 'overallOfficials': [{'name': 'Hadia Radwan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sharjah'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'after November 2018', 'ipdSharing': 'YES', 'description': 'All collected individual participant data (IPD)', 'accessCriteria': 'permission from the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sharjah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al Jalila Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hadia Radwan', 'investigatorAffiliation': 'University of Sharjah'}}}}