Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT01117961
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2010-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Healthy Weight Gain During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-30', 'studyFirstSubmitDate': '2010-04-15', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of women above the Institute of Medicine Guidelines for gestational weight gain', 'timeFrame': '40 weeks', 'description': 'Objective measures of weight collected by trained staff on calibrated scales at study entry and after delivery to classify women as above or below the Institute of Medicine Guidelines for gestational weight gain'}], 'secondaryOutcomes': [{'measure': 'Behavioral measures', 'timeFrame': '40 weeks', 'description': 'The Block Food Frequency questionnaire and Paffenbarger physical activity questionnaire will be used to assess diet and exercise behavior.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Excessive gestational weight gain'], 'conditions': ['Weight Gain']}, 'referencesModule': {'references': [{'pmid': '28525293', 'type': 'DERIVED', 'citation': 'Mercado A, Marquez B, Abrams B, Phipps MG, Wing RR, Phelan S. Where Do Women Get Advice About Weight, Eating, and Physical Activity During Pregnancy? J Womens Health (Larchmt). 2017 Sep;26(9):951-956. doi: 10.1089/jwh.2016.6078. Epub 2017 May 19.'}, {'pmid': '24284438', 'type': 'DERIVED', 'citation': 'Phelan S, Phipps MG, Abrams B, Darroch F, Grantham K, Schaffner A, Wing RR. Does behavioral intervention in pregnancy reduce postpartum weight retention? Twelve-month outcomes of the Fit for Delivery randomized trial. Am J Clin Nutr. 2014 Feb;99(2):302-11. doi: 10.3945/ajcn.113.070151. Epub 2013 Nov 27.'}, {'pmid': '21310836', 'type': 'DERIVED', 'citation': 'Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.\n\nIt is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-smoking, adults,\n* \\< 16 weeks gestation\n\nExclusion Criteria:\n\n* medical comorbidities'}, 'identificationModule': {'nctId': 'NCT01117961', 'briefTitle': 'Promoting Healthy Weight Gain During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'Promoting Healthy Weight Gain During Pregnancy', 'orgStudyIdInfo': {'id': 'CMTT# 2035-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Lifestyle intervention delivered during pregnancy', 'interventionNames': ['Behavioral: Lifestyle']}], 'interventions': [{'name': 'Lifestyle', 'type': 'BEHAVIORAL', 'description': 'Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain', 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Polytechnic State University-San Luis Obispo', 'class': 'OTHER'}, {'name': 'Women and Infants Hospital of Rhode Island', 'class': 'OTHER'}, {'name': 'University of California, Berkeley', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rena R. Wing', 'investigatorAffiliation': 'The Miriam Hospital'}}}}