Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-13 @ 12:37 PM
Study NCT ID:
NCT01923350
Status:
COMPLETED
Last Update Posted:
2013-08-15
First Post:
2013-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avoiding Diabetes After Pregnancy Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-14', 'studyFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2013-08-14', 'lastUpdatePostDateStruct': {'date': '2013-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For participants in weight group, weight reduction from baseline to 6 months', 'timeFrame': '6 months', 'description': "Participants reported their weights online at baseline, 3 months, 6 months, and 9 months, and the difference in weight from baseline to 6 months was the primary measure of the intervention's success."}, {'measure': 'In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period', 'timeFrame': '6 months', 'description': 'The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.'}], 'secondaryOutcomes': [{'measure': 'Weight intervention participant engagement with the interactive technology-based supports', 'timeFrame': '9 months', 'description': 'Measured by separate scores for taking part in behavioral support (coaching calls) and electronic feedback (women responding on goal performance via daily text messaging (SMS)or weekly IVR, chosen by the participant).'}, {'measure': 'Success of participants in weight intervention arm in achieving behavior change goals.', 'timeFrame': '9 months', 'description': "Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores."}, {'measure': 'Weight change from baseline to 9 months', 'timeFrame': '9 months', 'description': 'Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.'}, {'measure': 'Weight change from 6 to 9 months', 'timeFrame': '3 months', 'description': 'Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Weight reduction', 'Behavioral intervention', 'Gestational diabetes mellitus', 'Type 2 diabetes', 'Diabetes testing'], 'conditions': ['Weight Reduction']}, 'referencesModule': {'references': [{'pmid': '24886128', 'type': 'DERIVED', 'citation': 'Paez KA, Griffey SJ, Thompson J, Gillman MW. Validation of self-reported weights and heights in the avoiding diabetes after pregnancy trial (ADAPT). BMC Med Res Methodol. 2014 May 13;14:65. doi: 10.1186/1471-2288-14-65.'}]}, 'descriptionModule': {'briefSummary': "The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the effectiveness of interventions that potentially increase the adoption of Diabetes Prevention Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus (GDM).\n\nThe study was conducted as an integrated trial with two separate arms: one to facilitate weight reduction and the other to increase diabetes testing.\n\nThere were two hypotheses:\n\n1. Women in the testing intervention will be more likely to have received a diabetes test within the 6 months post-intervention than women in the control group.\n2. Women in the weight reduction intervention will have lost more weight at the 6-month and 9-month follow-up than women in the control group.\n\nThe primary study aim was to determine the efficacy of a system of interactive technology-based supports to prompt women with a history of gestational diabetes to take steps to prevent diabetes. The secondary aims were focused on women's engagement:\n\n* To evaluate the impact of the weight reduction intervention in terms of participant engagement with the interactive technology-based supports.\n* To evaluate changes in the women's perception of their personal diabetes risk following after exposure to information about diabetes risk following a pregnancy with GDM.\n* To identify the determinants and motivators of and barriers to diabetes testing in the 6- to 12-week postpartum period and thereafter, using the Health Belief model to guide the study.\n\nThere was an additional secondary aim involving metformin:\n\n* To evaluate the impact of the diabetes risk reduction intervention in terms of women seeking out their physician's advice on metformin treatment and receiving a metformin prescription, if appropriate."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral\n\n* History of GDM in the previous 6 months to 4.5 years\n* Access to the internet and text messages or phone messages\n* Current patient of Harvard Vanguard Medical Associates\n* 18 years of age or older\n* Able to read in English\n\nWeight Reduction Group\n\n* Overweight or obese\n* Capable of performing moderate physical activity\n\nDiabetes Testing Group\n\n* Had not competed a diabetes test (OGTT or fasting blood sugar at 6-12 weeks postpartum or OGTT, fasting blood sugar or hemoglobin A1c after 12 weeks postpartum)\n\nExclusion Criteria:\n\nGeneral:\n\n* Diabetes diagnosis\n* Psychotic disorder diagnosis\n* Enrolled in a research study\n\nWeight Reduction Group\n\n* Taking prescription medications for weight loss\n* Engaged in a formal weight reduction program\n\nDiabetes Testing Group\n\n* History of postpartum OGTT, fasting plasma glucose or hemoglobin A1c (after 6 weeks postpartum)'}, 'identificationModule': {'nctId': 'NCT01923350', 'acronym': 'ADAPT', 'briefTitle': 'Avoiding Diabetes After Pregnancy Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Social & Scientific Systems Inc.'}, 'officialTitle': 'Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'NDEP-GDM GS10F0381L'}, 'secondaryIdInfos': [{'id': 'GS10F0381L', 'type': 'OTHER_GRANT', 'domain': 'GSA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weight Reduction Intervention', 'interventionNames': ['Behavioral: Weight Reduction Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight Reduction Control Arm', 'interventionNames': ['Behavioral: Weight Reduction Control Arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tested for diabetes', 'interventionNames': ['Behavioral: Tested for diabetes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Not tested for diabetes', 'interventionNames': ['Behavioral: Not tested for diabetes']}], 'interventions': [{'name': 'Weight Reduction Intervention', 'type': 'BEHAVIORAL', 'description': "The weight trial intervention components were:\n\n* Electronic feedback from the ADAPT interactive obesity treatment approach (iOTA) system, tracking participants' behavior change goals. Participants received feedback either by daily SMS (text messaging) or by weekly IVR (interactive automated calls).\n* Seven behavior change coaching calls, once a month for 6 months, and then one at 7.5 months halfway through the maintenance period.\n* Print mailings/emailings\n* 3 Get Ready e-messages in the four weeks before the weight intervention began\n* Pedometers and program guides. (IVR users received printed activity logs with their program guides.)\n* Access to the ADAPT iOTA website for reviewing their progress and obtaining information on behavior change goals.", 'armGroupLabels': ['Weight Reduction Intervention']}, {'name': 'Weight Reduction Control Arm', 'type': 'BEHAVIORAL', 'description': 'Participants received an initial brochure about managing diabetes risk, a digital scale to use in entering their weights in online questionnaires, and monthly emailed wellness messages unrelated to diabetes.', 'armGroupLabels': ['Weight Reduction Control Arm']}, {'name': 'Tested for diabetes', 'type': 'BEHAVIORAL', 'description': 'Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a sub-sample of those tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.', 'armGroupLabels': ['Tested for diabetes']}, {'name': 'Not tested for diabetes', 'type': 'BEHAVIORAL', 'description': 'Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a subsample of those not tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.', 'armGroupLabels': ['Not tested for diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20910', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'Social & Scientific Systems Inc.', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}], 'overallOfficials': [{'name': 'Susan J Griffey, DPh, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Social & Scientific Systems Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Social & Scientific Systems Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Harvard Pilgrim Health Care', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Harvard Vanguard Medical Associates', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}