Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 12:00 PM
Study NCT ID:
NCT00364403
Status:
COMPLETED
Last Update Posted:
2010-08-30
First Post:
2006-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Low Glycemic Load Diet During Pregnancy in Overweight Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'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': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-27', 'studyFirstSubmitDate': '2006-08-14', 'studyFirstSubmitQcDate': '2006-08-14', 'lastUpdatePostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Birth weight as assessed by z-scores', 'timeFrame': 'At birth'}], 'secondaryOutcomes': [{'measure': 'Maternal energy intake', 'timeFrame': 'During pregnancy'}, {'measure': 'Maternal weight gain', 'timeFrame': 'During pregnancy'}, {'measure': 'Maternal insulin resistance assessed by HOMA', 'timeFrame': 'During pregnancy'}, {'measure': 'Maternal metabolic syndrome components', 'timeFrame': 'During pregnancy'}, {'measure': 'Infant body composition (ponderal index, skinfold thickness)', 'timeFrame': 'At birth'}, {'measure': 'Cord blood glucose', 'timeFrame': 'At birth'}, {'measure': 'cord blood insulin', 'timeFrame': 'At birth'}, {'measure': 'cord blood leptin', 'timeFrame': 'At birth'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glycemic index', 'Glycemic load', 'Low fat', 'Impaired glucose tolerance', 'Large for gestational age infant', 'Excessive body weight'], 'conditions': ['Overweight', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '20962162', 'type': 'DERIVED', 'citation': 'Rhodes ET, Pawlak DB, Takoudes TC, Ebbeling CB, Feldman HA, Lovesky MM, Cooke EA, Leidig MM, Ludwig DS. Effects of a low-glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial. Am J Clin Nutr. 2010 Dec;92(6):1306-15. doi: 10.3945/ajcn.2010.30130. Epub 2010 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with prepregnant or first trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2\n* Singleton pregnancy\n* Willing to consume the diets for duration of pregnancy\n* Participant to be at week 28 or less of pregnancy at baseline visit\n\nExclusion Criteria:\n\n* Smoking during pregnancy\n* Major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease)\n* Patients taking prescription medication known to affect body weight\n* Alcohol consumption during pregnancy\n* Patients who declare their intention to deliver infants in the environment outside of Beth Israel Deaconess Medical Center, Boston\n* High level of physical activity'}, 'identificationModule': {'nctId': 'NCT00364403', 'briefTitle': 'A Low Glycemic Load Diet During Pregnancy in Overweight Women', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women', 'orgStudyIdInfo': {'id': 'R03DK073335', 'link': 'https://reporter.nih.gov/quickSearch/R03DK073335', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R03DK073335', 'link': 'https://reporter.nih.gov/quickSearch/R03DK073335', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Low glycemic load diet', 'interventionNames': ['Behavioral: Low glycemic load']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Low fat diet', 'interventionNames': ['Behavioral: Low fat diet']}], 'interventions': [{'name': 'Low glycemic load', 'type': 'BEHAVIORAL', 'description': 'Provision of foods and dietary counseling to promote a low glycemic load diet', 'armGroupLabels': ['1']}, {'name': 'Low fat diet', 'type': 'BEHAVIORAL', 'description': 'Provision of foods and dietary counseling to promote a low fat diet', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David S Ludwig, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'Erinn Rhodes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Thrasher Research Fund', 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'David Ludwig, MD, PhD', 'oldOrganization': "Children's Hospital Boston"}}}}