Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-31 @ 6:18 PM
Study NCT ID:
NCT01782105
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'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': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2012-06-18', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight change during pregnancy', 'timeFrame': 'Weeks 12, 24, 36 of gestation'}], 'secondaryOutcomes': [{'measure': 'Levels of maternal and fetal adipokines', 'timeFrame': 'Weeks 12, 24 of gestation and at delivery (in cord blood)'}, {'measure': 'Maternal and fetal glycemic control', 'timeFrame': 'Weeks 12, 24 of gestation and at delivery', 'description': 'Results of glucose tolerance test (50g and 75g)'}, {'measure': 'Determine whether the adoption of healthy lifestyle in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.', 'timeFrame': 'Weeks 12, 24 of gestation and at delivery (cord blood)'}, {'measure': 'Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale.', 'timeFrame': 'throughout the study', 'description': 'Documentation will be collected about appreciation of the participants and attendance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['weight gain', 'healthy lifestyle', 'gestational diabetes', 'adipokins', 'glycemic regulation'], 'conditions': ['Excessive Weight Gain During Pregnancy', 'Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study are:\n\n* Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on:\n\n * weight gain in pregnancy\n * the levels of maternal and fetal adipokines and\n * glycemic control maternal and fetal.\n* Determine whether the adoption of healthy lifestyles in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be aged ≥ 18 years,\n* have a pre-pregnancy BMI ≥ 25 kg/m2,\n* be at risk of developing a gestational diabetes mellitus (a history of gestational diabetes mellitus or glucose 1 hour post-50g \\> 7.1 mmol/L.\n\nExclusion Criteria:\n\n* Pre-pregnancy diabetes detected in the first trimester (A1c \\> 6.5%, fasting glucose \\> 7.0 mmol/L, random blood glucose\\> 11.1 mmol/L, glucose \\> 10.3 mmol/L 1 hour post-50g)\n* twin pregnancy\n* taking medications that can affect blood sugar or weight,\n* practice ≥ 150 minutes of physical activity per week\n* against formal-indication for physical activity.'}, 'identificationModule': {'nctId': 'NCT01782105', 'briefTitle': 'Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': "Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie", 'orgStudyIdInfo': {'id': 'I-CHANGE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'In addition to the usual monitoring of pregnancy, this group will receive information about the recommended weight gain during pregnancy and an evaluation about of their nutritional and physical activity habits.', 'interventionNames': ['Behavioral: Control group']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'This group will receive a regular monitoring by health professionals (nutritionist and kinesiologist) who will ensure nutritional changes and physical activity necessary to secure the adoption of a healthy lifestyle and could participate to a physical activity group session once a week until week 36 of gestation.\n\nThe intervention include:\n\nA nutritional counseling every 2 weeks by a nutritionist until week 36 of gestation; a physical activity group session once a week lead by a kinesiologist until week 36 of gestation; 2 sessions of physical activity counseling (weeks 12 and 24).', 'interventionNames': ['Behavioral: Healthy lifestyle counseling']}], 'interventions': [{'name': 'Healthy lifestyle counseling', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention group'], 'description': 'Nutritionnal and physical activity counseling and physical activity session group', 'armGroupLabels': ['Intervention group']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'Evaluation of nutritional and physcial activity habits', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Marie-France Hivert, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Diabetes Québec', 'class': 'OTHER'}, {'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'Marie-France Hivert', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}