Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-21 @ 4:11 AM
Study NCT ID:
NCT04025892
Status:
WITHDRAWN
Last Update Posted:
2020-03-09
First Post:
2019-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy Tracking Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000078064', 'term': 'Gestational Weight Gain'}], 'ancestors': [{'id': 'D015430', 'term': 'Weight Gain'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Inadequate resources to support study start-up', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of scale use', 'timeFrame': 'Approximately 6 weeks', 'description': 'The number of times weight is measured on the scale'}], 'secondaryOutcomes': [{'measure': 'Weight change trajectories during scale use', 'timeFrame': 'Approximately 6 weeks', 'description': 'Average weight change over the study duration'}, {'measure': 'Knowledge of gestational weight gain guidelines', 'timeFrame': 'During baseline visit (~ 1 hour)', 'description': 'Score of response from baseline survey item inquiring about awareness of gestational weight gain where greater score indicates greater knowledge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'digital health', 'daily weighing'], 'conditions': ['Gestational Weight Gain']}, 'descriptionModule': {'briefSummary': 'This pilot study will examine perceptions about daily weighing for pregnant women with overweight or obesity by testing the feasibility, acceptability, and preliminary efficacy of daily weighing for reducing excess gestational weight gain (GWG) within the context of a low intensity, digital-health based intervention delivered remotely with electronic feedback to participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women ages 18-34\n* first pregnancy and at 13-20 weeks' gestation\n* low-risk uncomplicated pregnancy\n* overweight or obese at the time they became pregnant\n* willing to receive emails.\n\nExclusion Criteria:\n\n* Individuals who are not pregnant\n* not willing to receive emails\n* pregnant women expecting more than a single birth,\n* outside the window of 13-20 weeks' gestation\n* high-risk or complicated pregnancy for which participation would be contraindicated\n* advanced maternal age according to obstetric guidelines (i.e., age 35 or older)\n* diabetes\n* history of eating disorders\n* pre-pregnancy weight less than 25 kg/m2or greater than 36 kg/m2 (either not overweight or with extreme obesity)"}, 'identificationModule': {'nctId': 'NCT04025892', 'briefTitle': 'Pregnancy Tracking Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Pilot and Feasibility Study of Daily Weight Tracking to Manage Gestational Weight Gain During Pregnancy', 'orgStudyIdInfo': {'id': 'Pro00102563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tracking group', 'description': 'Participants will be asked to track weight daily for six weeks', 'interventionNames': ['Behavioral: Daily weighing']}], 'interventions': [{'name': 'Daily weighing', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to use the scale to track their body weight daily at home for six weeks. They will receive a weekly email contact with weight change feedback and either a nutrition or physical activity tip for the week. The study procedures represent minimal risks, and participants will be reminded and encouraged to maintain their regular prenatal care contacts with their provider.', 'armGroupLabels': ['Tracking group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Global Digital Health Science Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Dori Steinberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DUSON'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}