Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 5:45 PM
Study NCT ID:
NCT01545492
Status:
UNKNOWN
Last Update Posted:
2012-03-06
First Post:
2012-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Developmental Origins Hypothesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. \\~150 strands of hair\n2. Four buccal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 626}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-01', 'studyFirstSubmitDate': '2012-02-24', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "difference in 'change in z score for weight' at 12 m(+/- 2m)", 'timeFrame': 'birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m', 'description': "Between-group difference in early postnatal weight gain ('change in z score for weight') between birth and 12 m (p\\<0.05), 24m, 36m, 48m \\& 60m."}], 'secondaryOutcomes': [{'measure': 'hypothalamic pituitary adrenal axis function', 'timeFrame': 'average of 12m (+/-2m) of age', 'description': 'Hair collected at 12m (+/-2m) of age will be analysed for hypothalamic pituitary adrenal axis function (hair cortisol for overall cortisol production).'}, {'measure': 'differences in DNA methylation', 'timeFrame': 'average of 12 m (+/- 2m) of age', 'description': 'Buccal swab samples collected at 12m (+/-2m) of age will be assessed for between-groups differences in DNA methylation, using targeted (genes associated with growth, obesity, cardiovascular disease, and/or a developmental programming effect) and global (genome-wide microarray) methods.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CHIPS', 'famine', 'reprogramming', 'developmental', 'blood', 'pressure', 'randomised', 'randomized', 'hypertension', 'anthropometry', 'measurement', 'genetics', 'epigenetics', 'methylation', 'cortisol', 'stress', 'DNA', 'growth', 'weight', 'length', 'height'], 'conditions': ['Diabetes', 'Stroke', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '19711246', 'type': 'BACKGROUND', 'citation': 'Wadhwa PD, Buss C, Entringer S, Swanson JM. Developmental origins of health and disease: brief history of the approach and current focus on epigenetic mechanisms. Semin Reprod Med. 2009 Sep;27(5):358-68. doi: 10.1055/s-0029-1237424. Epub 2009 Aug 26.'}, {'pmid': '17465856', 'type': 'BACKGROUND', 'citation': 'Waterland RA, Michels KB. Epigenetic epidemiology of the developmental origins hypothesis. Annu Rev Nutr. 2007;27:363-88. doi: 10.1146/annurev.nutr.27.061406.093705.'}, {'pmid': '126533', 'type': 'BACKGROUND', 'citation': 'Gilbert EF, Varakis J, Opitz JM, ZuRhein GM, Ware R, Viseskul C, Kaveggia EG, Hartmann HA. Generalized gangliosidosis type II (juvenile GM1 gangliosidosis). A pathological, histochemical and ultrastructural study. Z Kinderheilkd. 1975 Sep 11;120(3):151-80. doi: 10.1007/BF00439006.'}, {'pmid': '15893910', 'type': 'BACKGROUND', 'citation': 'Painter RC, Roseboom TJ, Bleker OP. Prenatal exposure to the Dutch famine and disease in later life: an overview. Reprod Toxicol. 2005 Sep-Oct;20(3):345-52. doi: 10.1016/j.reprotox.2005.04.005.'}, {'pmid': '19656776', 'type': 'BACKGROUND', 'citation': 'Tobi EW, Lumey LH, Talens RP, Kremer D, Putter H, Stein AD, Slagboom PE, Heijmans BT. DNA methylation differences after exposure to prenatal famine are common and timing- and sex-specific. Hum Mol Genet. 2009 Nov 1;18(21):4046-53. doi: 10.1093/hmg/ddp353. Epub 2009 Aug 4.'}, {'pmid': '18074050', 'type': 'BACKGROUND', 'citation': 'Silveira PP, Portella AK, Goldani MZ, Barbieri MA. Developmental origins of health and disease (DOHaD). J Pediatr (Rio J). 2007 Nov-Dec;83(6):494-504. doi: 10.2223/JPED.1728.'}, {'pmid': '12653312', 'type': 'BACKGROUND', 'citation': 'Cameron N, Demerath EW. Critical periods in human growth and their relationship to diseases of aging. Am J Phys Anthropol. 2002;Suppl 35:159-84. doi: 10.1002/ajpa.10183.'}]}, 'descriptionModule': {'briefSummary': "INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control \\[target diastolic BP (dBP) 100mmHg\\] or 'tight' control \\[target dBP 85mmHg\\] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.\n\nCHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination \\[anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background\\]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.\n\nOBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.", 'detailedDescription': "INTRODUCTION: Growing evidence shows that reduced fetal growth rate is associated with adult cardiovascular risk markers (e.g., obesity) and disease, and evidence worldwide indicates that this relationship is independent of birthweight. The leading theory describes 'developmental programming' in utero leading to permanent alteration of the fetal genome. While those changes are adaptive in utero, they may be maladaptive postnatally.\n\nOBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.\n\nMETHODS: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control \\[target diastolic BP (dBP) 100mmHg\\] or 'tight' control \\[target dBP 85mmHg\\] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.\n\nCHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination \\[anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background\\]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.\n\nSample size:. CHIPS will recruit 1028 women. We estimate that 80% of CHIPS centres will participate in CHIPS-Child, approximately 97% of babies will survive, and 90% of children will be followed to 12 m resulting in a sample size of 626. Power will be \\>80% to detect a between-group difference of ≥0.25 in 'change in z-score for weight' between birth and 12 m (2-sided alpha=0.05, SD 1)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Only women participating in the CHIPS RCT and their children born after recruitment are eligible to participate in CHIPS-Child.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women participating in CHIPS and their children born after recruitment.\n\nExclusion Criteria:\n\n* Women who have experienced the loss of their pregnancy or child after recruitment into CHIPS.'}, 'identificationModule': {'nctId': 'NCT01545492', 'acronym': 'CHIPS-Child', 'briefTitle': 'Testing the Developmental Origins Hypothesis', 'organization': {'class': 'OTHER', 'fullName': "Children's & Women's Health Centre of British Columbia"}, 'officialTitle': 'CHIPS-Child:Testing the Developmental Origins Hypothesis', 'orgStudyIdInfo': {'id': 'H08-00882CHIPS-Child'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tight', 'description': 'Children born to women in the CHIPS RCT randomized to "Tight" blood pressure control \\[target diastolic BP 85mmHg\\]'}, {'label': 'Less Tight', 'description': 'Children born to women in the CHIPS RCT randomized to "Less Tight" \\[target diastolic BP 100mmHg\\].'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Norton Hospital Downtown & Suburban', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Copper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Ipswich', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': -27.62343, 'lon': 152.76067}}, {'city': 'Subiaco', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'King Edward Memorial Hospital', 'geoPoint': {'lat': -31.9485, 'lon': 115.8268}}, {'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Surrey', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Laura A Magee, MD FRCPC MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "BC Children & Women's Health Centre", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Sherbrooke', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'CHUS Fleurimont'}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Hopital Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Saskatoon', 'state': 'Saskatchewan', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'city': 'Osorno', 'status': 'RECRUITING', 'country': 'Chile', 'facility': 'Hospital Base Osorno', 'geoPoint': {'lat': -40.57395, 'lon': -73.13348}}, {'city': 'Puente Alto', 'status': 'RECRUITING', 'country': 'Chile', 'facility': 'Hospital Dr Sotero del Rio', 'geoPoint': {'lat': -33.61169, 'lon': -70.57577}}, {'city': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'facility': "Tartu University Hospital - Women's Clinic", 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'VU Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'UMCG', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Hilversum', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Tergooiziekenhuizen', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'MUMC Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nieuwegein', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'St Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Diakonessen Ziekenhuis', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'UMCU', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Veldhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Maxima Medical Centre', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'city': 'Zwolle', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Isala Klinieken Zwolle', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'city': 'Christchurch', 'status': 'RECRUITING', 'country': 'New Zealand', 'facility': "Christchurch Women's Hospital", 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "Birmingham Women's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bradford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Bradford Royal Infirmary', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'city': 'Lancaster', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Lancaster Infirmary', 'geoPoint': {'lat': 54.04649, 'lon': -2.79988}}, {'city': 'Newcastle upon Tyne', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'city': 'Nottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Ormskirk', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Southport & Ormskirk Hospital', 'geoPoint': {'lat': 53.56685, 'lon': -2.88178}}, {'city': 'Plymouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Sunderland', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'City Hospitals Sunderland NHS Foundation Trust', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'city': 'Swansea', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Singleton Hospital', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'city': 'Wolverhampton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'city': 'York', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'York District Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'centralContacts': [{'name': 'Kristal T Louie, MS', 'role': 'CONTACT', 'email': 'CHIPS-Child@cw.bc.ca', 'phone': '604.875.2424', 'phoneExt': '5321'}], 'overallOfficials': [{'name': 'Laura A Magee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "BC Children & Women's Health Centre"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's & Women's Health Centre of British Columbia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor of Medicine', 'investigatorFullName': 'Laura Magee', 'investigatorAffiliation': "Children's & Women's Health Centre of British Columbia"}}}}