Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-27 @ 4:31 PM
Study NCT ID:
NCT03455712
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2018-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of GWG Tool on Patient Knowledge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D000078064', 'term': 'Gestational 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects to be enrolled into the intervention and standard-of-care groups depending on their gestational age at the time of consent during the expected 2 month period of enrollment. Any subject who is between 6 weeks 0 days and 14 weeks 6 days of pregnancy at the time of consent and who has had no prior prenatal visits will be enrolled in the intervention group. Any subject who is between 15 weeks 0 days to 22 weeks 6 days of pregnancy at the time of consent and who has had at least one prior prenatal visit will be enrolled in the control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy-specific topic/guideline questionnaire responses', 'timeFrame': 'Outcome assessed up to 23 weeks gestation', 'description': 'Comparison of number of participants in control vs. intervention groups who correctly answer multiple choice and free response questions related to pregnancy-specific topics and guidelines following intervention.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy-specific topic/guideline questionnaire responses', 'timeFrame': 'Outcome assessed up to 23 weeks gestation', 'description': 'Description of general patient population knowledge of pregnancy-specific topics and guidelines from number of participants who correctly answer multiple choice and free response questions related to pregnancy-specific topics and guidelines prior to intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Gestational weight gain', 'Weight gain', 'Patient education', 'Patient knowledge', 'Institute of Medicine'], 'conditions': ['Weight Gain', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': "Women with singleton pregnancies at one outpatient clinic to be recruited for controlled clinical trial. Over eight weeks, women 15 0/7--22 6/7 weeks' with at least one prior prenatal visit to be enrolled in the control group. Women 6 0/7--14 6/7 weeks' to be enrolled in the intervention group at their first prenatal visit and to receive a pregnancy-specific gestational weight gain card. Women to be encouraged to record their weight at each prenatal care visit. All women to complete a GWG knowledge--based questionnaire at 15 0/7-22 6/7 weeks'."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton gestation\n* Primary prenatal care at MetroHealth Medical Center\n* Planning to deliver at MetroHealth Medical Center\n\nExclusion Criteria:\n\n* Any inclusion criteria not met\n* Prior diagnosis of eating disorder\n* Inadequate knowledge of English language'}, 'identificationModule': {'nctId': 'NCT03455712', 'briefTitle': 'Impact of GWG Tool on Patient Knowledge', 'organization': {'class': 'OTHER', 'fullName': 'MetroHealth Medical Center'}, 'officialTitle': 'Impact of a Patient Education Intervention on Maternal Knowledge of Gestational Weight Gain Recommendations', 'orgStudyIdInfo': {'id': 'IRB16-00295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Subjects to receive the Gestational Weight Gain Card at enrollment in addition to standard prenatal care.', 'interventionNames': ['Behavioral: Gestational Weight Gain Card']}, {'type': 'NO_INTERVENTION', 'label': 'Standard-of-Care', 'description': 'No intervention to be delivered. Subjects to receive standard prenatal care.'}], 'interventions': [{'name': 'Gestational Weight Gain Card', 'type': 'BEHAVIORAL', 'description': 'The Gestational Weight Gain Card is designed to be an educational and weight gain tracking tool. Study subjects will be highly encouraged to use the GWG card to gain both important clinical information and to document weight measurements throughout their pregnancy.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erica Berggren, MD, MSCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University School of Medicine, MetroHealth Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MetroHealth Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Allie Reid', 'investigatorAffiliation': 'MetroHealth Medical Center'}}}}