Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 10:40 AM
Study NCT ID:
NCT02617693
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-19', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in waist circumference', 'timeFrame': 'Months 0-8'}], 'secondaryOutcomes': [{'measure': 'Change in BMI (Body Mass Index)', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in waist-to-height ratio (WHtR)', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in waist-to-hip ratio', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in weight', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in HbA1c (Glycosylated haemoglobin))', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in the fasting lipid profile (total cholesterol [TC], low density lipoprotein cholesterol[LDL-C], high density lipoprotein cholesterol[HDL-C], triglycerides [TG])', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure))', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q)', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in dietary intake, as measured by the Frequency Food Questionnaire (FFQ) that is used in National Health Surveys in Malaysia', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in physical activity and sedentary behaviour, as measured by the International Physical Activity Questionnaire (IPAQ) used in National Health Surveys in Malaysia', 'timeFrame': 'Month 0, Month 8'}, {'measure': 'Change in stress levels, as measured by the Depression Anxiety and Stress Scale 21-items (DASS-21) used in National Health Surveys in Malaysia', 'timeFrame': 'Month 0, Month 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '27117703', 'type': 'DERIVED', 'citation': 'Skau JK, Nordin AB, Cheah JC, Ali R, Zainal R, Aris T, Ali ZM, Matzen P, Biesma R, Aagaard-Hansen J, Hanson MA, Norris SA. A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial. Trials. 2016 Apr 27;17(1):215. doi: 10.1186/s13063-016-1345-x.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia. The aim of this study is to assess the efficacy of a pre-pregnancy life style intervention to reduce the risk of diabetes and prediabetes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* Nulliparity\n* Not pregnant at the time of signing informed consent\n* Own a smartphone with either Android system version 4.1 and above or iOS system 7.0 and above with internet access\n\nExclusion Criteria:\n\n* Female subject undergoing treatment for type 1 or 2 diabetes mellitus\n* Subjects not residing in the district of Seremban'}, 'identificationModule': {'nctId': 'NCT02617693', 'acronym': 'Jom Mama', 'briefTitle': 'Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Jom Mama Project - Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes', 'orgStudyIdInfo': {'id': 'INS-4186'}, 'secondaryIdInfos': [{'id': 'U1111-1160-2987', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard of care', 'interventionNames': ['Other: standard antenatal care']}, {'type': 'EXPERIMENTAL', 'label': 'Life style intervention', 'interventionNames': ['Behavioral: lifestyle intervention']}], 'interventions': [{'name': 'lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Evaluation of lifestyle intervention combining behavioural change councelling and utilisation of E-health platform. The intervention consists of a combination of behaviour change counselling and support through six contact-points with CHPs (community health promoter) and access to a personalised mobile application.', 'armGroupLabels': ['Life style intervention']}, {'name': 'standard antenatal care', 'type': 'OTHER', 'description': 'Standard of care for pre-pregnancy health. Subjects will be reminded of their endpoint measurement visit towards the end of the intervention period through a phone call.', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70400', 'city': 'Seremban, Negeri Sembilan', 'country': 'Malaysia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 2.7297, 'lon': 101.9381}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}