Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-09 @ 8:32 PM
Study NCT ID:
NCT05299502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2022-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Eating in Women at Risk of Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting plasma glucose', 'timeFrame': 'Changes from the 1st to the 3rd trimester', 'description': 'Measured after a 12-hour fast.'}], 'secondaryOutcomes': [{'measure': 'Post-prandial plasma glucose', 'timeFrame': 'Changes from the 1st to the 3rd trimester', 'description': 'Measured 60 and 120 minutes during a 2-hour Oral Glucose Tolerance Test'}, {'measure': 'Glycemic response', 'timeFrame': 'Changes from the 1st to the 3rd trimester', 'description': 'Using incremental area under the curve for the blood glucose during a 2-hour Oral Glucose Tolerance Test'}, {'measure': 'Hepatic insulin sensitivity', 'timeFrame': 'Changes from the 1st to the 3rd trimester', 'description': 'Homeostasis Model Assessment of Insulin Sensibility'}, {'measure': 'Hepatic and peripheral insulin sensitivity index', 'timeFrame': 'Changes from the 1st to the 3rd trimester', 'description': 'Matsuda index'}, {'measure': 'Beta-cell function index', 'timeFrame': 'Changes from the 1st to the 3rd trimester', 'description': 'Disposition index: Matsuda index\\*insulinogenic index'}, {'measure': 'Gestational Diabetes Mellitus diagnosis', 'timeFrame': 'End of pregnancy', 'description': 'Incidence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Healthy Eating', 'Gestational Diabetes'], 'conditions': ['Gestational Diabetes', 'Pregnancy Complications']}, 'referencesModule': {'references': [{'pmid': '38312142', 'type': 'DERIVED', 'citation': 'Bernier E, Plante AS, Lemieux P, Robitaille J, Lemieux S, Desroches S, Belanger-Gravel A, Maheux-Lacroix S, Weisnagel SJ, Demers S, Camirand Lemyre F, Boulet M, Baillargeon JP, Morisset AS. Promoting healthy eating in early pregnancy in individuals at risk of gestational diabetes mellitus: does it improve glucose homeostasis? A study protocol for a randomized control trial. Front Nutr. 2024 Jan 19;10:1336509. doi: 10.3389/fnut.2023.1336509. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': "Healthy eating during pregnancy has favorable effects on markers related to diabetes (glucose tolerance) and is associated with lower gestational diabetes mellitus (GDM) risk. The cornerstone of GDM treatment is nutrition therapy but the latter often starts late in pregnancy and thus may not have the expected effects on glucose tolerance. What if an intervention promoting healthy eating was initiated at the beginning of pregnancy in all women at risk, would it improve glucose homeostasis? To answer this important question, the investigators will perform a randomized controlled trial in 150 pregnant women. Women receiving the nutritional intervention will be compared to a control group receiving standard care. The nutritional intervention, which will start in the first trimester, is based on the 2019 Canada's Food Guide and is composed of 4 individual sessions with a registered dietitian (12, 18, 24 and 30 weeks). Between those follow-ups, informative nutritional web capsules and phone calls with the registered dietitian will be provided. To ensure that the women remain motivated and receive social support, a private Facebook group will be used. The investigators hypothesize that the nutritional intervention will be effective at improving glucose homeostasis. The investigators expect the results will show the importance of nutritional care starting early in pregnancy in women at risk of GDM.", 'detailedDescription': 'Individuals will participate in three on-site research visits during which a 2-hour oral glucose tolerance test will be performed. At each of these trimesters and 3 months after the delivery, participants will also complete three validated web-based 24-h recalls from which diet quality will be assessed. Subjects will be randomized to two arms after the first oral glucose tolerance test at the first visit. For all participants, on-site follow-ups by the research team will occur at each trimester and 1 virtual follow-up will be done 3 months after delivery for both groups. The total duration of participation for all is approximately 9 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≤ 14 gestational weeks;\n* Singleton pregnancy;\n* At risk of GDM According to Diabetes Canada (being 35 years of age or older or from a high-risk group (African, Arab, Asian, Hispanic, Indigenous, or South Asian) or having a BMI ≥ 30 kg/m2, prediabetes, GDM in a previous pregnancy, given birth to a baby that weighed more than 4 kg, a parent, brother or sister with type 2 diabetes, polycystic ovary syndrome or acanthosis nigricans (darkened patches of skin).\n\nExclusion Criteria:\n\n* Having a diabetes diagnosis in the 1st trimester;\n* Pre-existing diabetes mellitus;\n* Diseases requiring active nutritional treatment or influencing glucose metabolism (including previous bariatric surgery);\n* Taking part in a nutritional intervention program;\n* Corticosteroid use;\n* Previous or current diagnosis of an eating disorder;\n* Inability to give informed consent;\n* Inability to communicate in French.'}, 'identificationModule': {'nctId': 'NCT05299502', 'acronym': 'SAGE', 'briefTitle': 'Healthy Eating in Women at Risk of Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Promoting Healthy Eating in Early Pregnancy in Women at Risk of Gestational Diabetes Mellitus: Does it Improve Glucose Homeostasis?', 'orgStudyIdInfo': {'id': '2022-6100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional Intervention', 'description': 'Intervention promoting healthy eating by a Registered Dietitian.', 'interventionNames': ['Behavioral: Nutritional Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Women will have their usual medical pregnancy follow-ups by their MDs without access to nutritional care.'}], 'interventions': [{'name': 'Nutritional Intervention', 'type': 'BEHAVIORAL', 'description': "4 individual 1-hour in person (or virtual, according to potential public health restrictions and patients' preference) motivational interviews (12, 18, 24 and 30 weeks) with a registered dietitian will be conducted to elaborate S.M.A.R.T. (Specific,Measurable, Attainable, Relevant, Timely) goals regarding diet, based on the 2019 Canada's Food Guide. Between those individual follow-ups, 4 phone calls with the registered dietitian will be provided (15, 21, 27, 33 weeks). Throughout the study, 10 informative nutritional video clips will also be provided. Participants receiving the intervention will have access to an online Facebook private community to discuss and share experiences, thus maintaining motivation and providing social support.", 'armGroupLabels': ['Nutritional Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Québec-Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Anne-Sophie Morisset, RD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Québec-Université Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Laval University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anne-Sophie Morisset', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}}