Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-31 @ 10:03 AM
Study NCT ID:
NCT00950235
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Weight Management for Improved Pregnancy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'victor.j.stevens@kpchr.org', 'phone': '503 335 6751', 'title': 'Victor J. Stevens, PhD Principle Investigator', 'organization': 'Kaiser Permanente Center for Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AE data collected at follow up visits (34wk gestation, 2 weeks post-partum, 6 and 12 months post partum)', 'description': 'AE data collected between November 2009 and July 2011, 20 months', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group\n\nUsual Care: Standard nutrition counseling from Health Plan', 'otherNumAtRisk': 60, 'otherNumAffected': 40, 'seriousNumAtRisk': 60, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Weight Management Counseling', 'description': 'In-person and group session counseling\n\nWeight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy', 'otherNumAtRisk': 58, 'otherNumAffected': 30, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cesarean Section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pre-Term Birth <37 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NICU admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory morbidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'miscarriage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maternal Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group\n\nUsual Care: Standard nutrition counseling from Health Plan'}, {'id': 'OG001', 'title': 'Weight Management Counseling', 'description': 'In-person and group session counseling\n\nWeight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 2 weeks post partum', 'description': 'We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was from follow up visit or validated clinical data'}, {'type': 'SECONDARY', 'title': 'Pregnancy Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group\n\nUsual Care: Standard nutrition counseling from Health Plan'}, {'id': 'OG001', 'title': 'Weight Management Counseling', 'description': 'In-person and group session counseling\n\nWeight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 34 weeks gestation', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants returning for follow up visit or validated clinical data'}, {'type': 'SECONDARY', 'title': 'Large for Gestational Age (LGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group\n\nUsual Care: Standard nutrition counseling from Health Plan'}, {'id': 'OG001', 'title': 'Weight Management Counseling', 'description': 'In-person and group session counseling\n\nWeight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At birth', 'description': 'Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Babies born to participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group\n\nUsual Care: Standard nutrition counseling from Health Plan'}, {'id': 'FG001', 'title': 'Weight Management Counseling', 'description': 'In-person and group session counseling\n\nWeight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'English speaking, obese, age 18 or older receiving pregnancy care at an prepaid health plan clinic. Less than 21 weeks gestation. Recruitment November 2009-July 2011.', 'preAssignmentDetails': 'Women were invited to attend an informational meeting which explained the study and covered the elements of consent. Interested volunteers were asked to come back to the research setting for the baseline visit. Randomization occurred at the baseline visit after a final review of eligibility and signing a consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group\n\nUsual Care: Standard nutrition counseling from Health Plan'}, {'id': 'BG001', 'title': 'Weight Management Counseling', 'description': 'In-person and group session counseling\n\nWeight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '100.5', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '98.8', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '99.7', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2009-07-29', 'resultsFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2009-07-30', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-11', 'studyFirstPostDateStruct': {'date': '2009-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Weight Change', 'timeFrame': 'baseline to 2 weeks post partum', 'description': 'We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy Weight Change', 'timeFrame': 'baseline to 34 weeks gestation'}, {'measure': 'Large for Gestational Age (LGA)', 'timeFrame': 'At birth', 'description': 'Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obese', 'pregnant', 'large for gestational age', 'large for gestational age baby'], 'conditions': ['Obesity', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '25164259', 'type': 'DERIVED', 'citation': 'Vesco KK, Karanja N, King JC, Gillman MW, Leo MC, Perrin N, McEvoy CT, Eckhardt CL, Smith KS, Stevens VJ. Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial. Obesity (Silver Spring). 2014 Sep;22(9):1989-96. doi: 10.1002/oby.20831.'}, {'pmid': '22465256', 'type': 'DERIVED', 'citation': 'Vesco KK, Karanja N, King JC, Gillman MW, Perrin N, McEvoy C, Eckhardt C, Smith KS, Stevens VJ. Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale. Contemp Clin Trials. 2012 Jul;33(4):777-85. doi: 10.1016/j.cct.2012.03.006. Epub 2012 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 30 or more\n* Less than 20 weeks gestation\n* member of Kaiser Permanente Northwest (NW)\n* receive pre-natal care at Kaiser Permanente NW\n* speaks English\n\nExclusion Criteria:\n\n* no current treatment for cancer\n* no bariatric surgery\n* no current renal disease\n* no multiple birth anticipated\n* no hyperemesis requiring hospitalization\n* no diabetes (type 1 or 2)'}, 'identificationModule': {'nctId': 'NCT00950235', 'acronym': 'Healthy Moms', 'briefTitle': 'Weight Management for Improved Pregnancy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Weight Management for Improved Pregnancy Outcomes', 'orgStudyIdInfo': {'id': '1R01HD058061-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD058061-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01HD058061', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD058061', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Usual Care', 'description': 'This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group', 'interventionNames': ['Other: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Weight Management Counseling', 'description': 'In-person and group session counseling', 'interventionNames': ['Behavioral: Weight Management']}], 'interventions': [{'name': 'Weight Management', 'type': 'BEHAVIORAL', 'description': 'Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy', 'armGroupLabels': ['Weight Management Counseling']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Standard nutrition counseling from Health Plan', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Victor J Stevens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}