Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT05744856
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2022-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Co-created Self-care and Informal Support Intervention Study Among Women With GDM in Vietnam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-22', 'releaseDate': '2025-09-25'}, {'resetDate': '2025-12-03', 'releaseDate': '2025-11-15'}], 'estimatedResultsFirstSubmitDate': '2025-09-25'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D012648', 'term': 'Self Care'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Due to the overt nature of the intervention, it is not possible to blind the participants, healthcare providers nor the investigators.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is parallel 2-arm non-randomized intervention study with a delayed-start for the intervention group. The study population will be recruited in two phases. Over a period of 4 months (phase I) 1000 pregnant women will be screened for GDM among which 200 will be diagnosed with GDM and receive standard GDM care according to national guidelines in Vietnam (control group). During phase I, the "self-care + informal support intervention" will be co-created with local health care staff and a sub-group of the control group. Four months after the recruitment for phase I has finished, recruitment for phase II will start. Over a period of 4 months, another 1000 pregnant will be screened for GDM among which 200 will be diagnosed with GDM. These 200 women will be invited to receive the "self-care + informal support" intervention (intervention group). This pilot study is designed to inform a power calculation and logistics of a future full-scale randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diet', 'timeFrame': 'Study month 3 and 6/Gestational age 24 and 36', 'description': 'Change in diet measured through ad hoc developed questions'}, {'measure': 'Physical activity', 'timeFrame': 'Study month 3 and 6/Gestational age 24 and 36', 'description': 'Change in physical activity measured through ad hoc developed questions'}, {'measure': 'Episiotomy', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Number of participants where episiotomy is performed during delivery'}, {'measure': 'PPROM', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Number of participants with Premature Primary Rupture of Membranes'}, {'measure': 'Prevalence of GDM', 'timeFrame': 'Study month 3/Gestational age 24', 'description': 'Number of participants with GDM diagnosed according to WHO criteria'}, {'measure': 'Risk factors of GDM', 'timeFrame': 'Study month 3/Gestational age 24', 'description': 'Number of pre-gestational and gestational risk factors for GDM prevalent among participants diagnosed with GDM (risk factor are defined as according to those known in the literature, e.g. age, BMI, family disposition, gestational weigh gain)'}, {'measure': 'Perception of GDM', 'timeFrame': 'Study month 3 to 7/Gestational age 24 to 40 (delivery)', 'description': 'Ethnographic study conducted among approximately 40 pregnant women with GDM and their informal support persons (20 from intervention group and 20 from control group)'}, {'measure': 'GDM self-care practices', 'timeFrame': 'Study month 3 to 7/Gestational age 24 to 40 (delivery)', 'description': 'Ethnographic study conducted among approximately 40 pregnant women with GDM and their informal support persons (20 from intervention group and 20 from control group)'}, {'measure': 'Perception of "self-care/informal support" intervention', 'timeFrame': 'Study month 3 to 10/Gestational age 24 to 12 weeks post-partum', 'description': 'Ethnographic study conducted among approximately 20 pregnant women with GDM and their informal support persons (intervention group)'}, {'measure': 'Family health', 'timeFrame': 'Study month 6/Gestational age 36', 'description': 'The short form version of the Family Health Scale \\[10 items on a 5-point scale ranging from 1-5\\]. A total score of 0-5 indicates poor family health, 6-8 indicates moderate family health, and 9-10 indicates excellent family health'}, {'measure': 'Costs', 'timeFrame': 'Throughout whole study (study month 0-10)', 'description': 'Direct economic costs (in Vietnamese Dong/VND and USD) and indirect costs (human ressources measured in hours) spent on developing the intervention'}], 'primaryOutcomes': [{'measure': 'Large for gestational age (LGA)', 'timeFrame': 'Delivery (study month 7 after enrolment/Gestational age 40)', 'description': 'Number of newborns with birth weight above the 90th percentile according to gender and gestational age (INTERGROWTH)'}, {'measure': 'The feasibility of the self-care intervention [recruitment]', 'timeFrame': 'Recruitment (study month 0)', 'description': 'Number of women eligible for the study who accepts to be included in the intervention arm.'}, {'measure': 'The feasibility of the self-care intervention [retention]', 'timeFrame': 'Recruitment to post-partum evaluation (study month 0-10)', 'description': 'Number of included women in the intervention group who completes the study (delivery data and post-partum interview).'}, {'measure': 'The acceptability of the self-care intervention', 'timeFrame': 'Study month 3 to 10 /Gestational age 24 to 12 weeks post-partum', 'description': 'Acceptability will be measured in a combined quantitative and qualitative study. It will be measured quantitatively via 5-point likert scales among the intervention group \\[Range: 1-5; Minimum score: 1; Maximum score: 5; Higher score indicates high acceptability\\]. It will be assessed qualitatively among a sub-group of the intervention group through a ethnographic study.'}], 'secondaryOutcomes': [{'measure': 'Mode of delivery', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Number of participants with spontaneous vaginal delivery, assisted vaginal delivery, planned c-section or emergency c-section'}, {'measure': 'Pre-term birth below gestational age 37+0', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Number of participants with spontaneous preterm birth or medical induced preterm birth'}, {'measure': 'Gestational age', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'The gestational age of newborns at delivery'}, {'measure': 'Birth weight', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Birth weight of newborns measured in grams'}, {'measure': 'Macrosomia', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Number of newborns with birth weight above 4000g'}, {'measure': 'Macrosomia (Vietnam)', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Number of newborns with birth weight above 3500g'}, {'measure': 'Live-born', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Newborns that are live-born (Yes/no)'}, {'measure': 'Small for gestational age (SGA)', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Number of newborns below the 10th percentile for birth weight according to gestational age'}, {'measure': 'Apgar score', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'The Apgar score of newborns measured 1 and 5 minutes after delivery (score: 0-10)'}, {'measure': 'Neonatal hypoglycemia', 'timeFrame': 'Delivery (study month 7/Gestational age 40)', 'description': 'Measurement of blood glucose (mmol/l) in newborns'}, {'measure': 'Maternal gestational weight gain', 'timeFrame': 'Study month 0 and 6/Gestational age 12 and 36', 'description': 'Change in delta weight (kilogram) among participants between gestational age 36 minus first measured/pre-gestational weight'}, {'measure': 'HbA1c', 'timeFrame': 'Study month 3 and 7/Gestational age 24 and 40 (delivery)', 'description': 'Change in delta score among participants between gestational age 24 and 40 (delivery)'}, {'measure': 'Breast feeding practices', 'timeFrame': 'Study month 10 (12 weeks post-partum)', 'description': "Participants' breast feeding practices measured through ad hoc developed questions"}, {'measure': 'Post-partum depression', 'timeFrame': 'Study month 3 and 10/Gestational age 24 and 12 weeks postpartum', 'description': 'Change in delta score among participants measured through the Edinburgh postpartum depression scale (EPDS) \\[10 items on 4-point scale ranging from 0-3\\]'}, {'measure': 'Perceived social support', 'timeFrame': 'Study month 3,6 and 10/Gestational age 24, 36 and 12 weeks postpartum', 'description': 'Change in delta score among participants measured through the Multidimensional Scale of Perceived Social Support scale (MSPSS) \\[11 item 7-point scale ranging from 1-7\\]'}, {'measure': 'Well-being', 'timeFrame': 'Study month 0, 3, 6 and 10/Gestational age 12, 24, 36 and 12 weeks postpartum', 'description': 'Change in delta scores measured through WHO 5 Wellbeing index \\[5 items on 6-point scale ranging from 0-5\\]'}, {'measure': 'Self-care Agency', 'timeFrame': 'Study month 3 and 6/Gestational age 24 and 36', 'description': 'Difference in score between intervention and comparator group measured through the Self-care Agency Scale-Revised (ASAS-R) \\[15 items on 5-point scale ranging from 1-5\\]'}, {'measure': 'Self-care of GDM', 'timeFrame': 'Study month 6/Gestational age 36', 'description': 'Difference in score between intervention and comparator group measured through the Summary of Diabetes Self- Care Activities (SDSCA) \\[10 items on 8-point scale ranging 0-7\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GDM', 'Co-creation', 'Self-care', 'Vietnam', 'Low-and-middle-income countries', 'Informal support', 'Intervention'], 'conditions': ['GDM']}, 'referencesModule': {'references': [{'pmid': '40442746', 'type': 'DERIVED', 'citation': 'Linde DS, Le HM, Vu DTK, Dang NT, Nguyen AT, Vu TP, Nguyen XB, Nguyen CD, Meyrowitsch DW, Sondergaard J, Vinter CA, Bygbjerg IC, Rasch V, Nguyen TD, Gammeltoft TM, Nguyen DK. A co-created self-care and informal support intervention targeting women with gestational diabetes mellitus in northern Vietnam (VALID-II): a protocol for a two-arm non-randomised feasibility study. Pilot Feasibility Stud. 2025 May 29;11(1):73. doi: 10.1186/s40814-025-01657-x.'}]}, 'descriptionModule': {'briefSummary': "Gestational Diabetes Mellitus (GDM) is significant public health problem in Vietnam, which is potentially treatable if managed properly by the pregnant women once diagnosed. However, systematic screening for GDM is rarely undertaken in Vietnam, and little is known about how health providers, pregnant women, and their families in today's Vietnam handle the condition. Vietnamese women often depend on their extended family for daily life management and access to social and financial resources, hence, an intervention that focuses on informal support and GDM self-care may increase adherence the standard guidelines among pregnant women with GDM in Vietnam and increase neonatal and maternal health outcomes.", 'detailedDescription': 'Background: Across the globe, diabetes mellitus is attaining epidemic proportions, with low- and middle-income countries confronting particularly high burdens. VALID II focuses on gestational diabetes mellitus (GDM), a transitory form of diabetes that presents during pregnancy.\n\nObjectives: To: i) Determine prevalence and risk factors for GDM among pregnant women in Vietnam\'s Thai Binh province, ii) Measure the associations between GDM and pregnancy complications and outcomes, iii) Understand how pregnant women with GDM and their informal support persons perceive and handle the condition, iv) Co-create, implement, and assess the feasibility of a intervention aiming to enhance the self-care capacities of pregnant women with GDM.\n\nStudy setting: Thai Binh, Vietnam\n\nStudy design: Intervention study\n\nStudy population: 2,000 pregnant women attending antenatal care.\n\nMethodology: The study will be performed as a pilot parallel 2-arm non-randomized intervention study with a delayed-start for the intervention group. 1000 women will be invited into the study at their first antenatal care visit (gestational week 12) and complete a questionnaire (inclusion questionnaire). All women will be offered a 2-hour oral glucose tolerance test (OGTT) in gestational week 24-28 and complete second questionnaire (OGTT questionnaire) exploring living conditions, lifestyle, risk factors, selfcare, perceived social support, perceived wellbeing, and sign of depression. An estimated 200 women (\\~20%) will screen positive for GDM by the OGTT according to the World Health Organization (WHO) 2013 diagnostic criteria and receive standard GDM care. These 200 women will serve as the study\'s control group (study phase I). Among the 200 women who screen positive in phase I, ethnographic interviews will be formed in a subgroup of 20 women. The information from the 20 ethnographic interviews and the 200 questionnaire interviews will help inform a co-created "self-care and informal support" intervention. Subsequently, another 1000 women will be invited into the study at their first antenatal care visit and be offered a 2-hour oral glucose tolerance test (OGTT) in gestational week 24-28 (study phase II). An estimated 200 women (\\~20%) will screen positive for GDM, and these women will receive the co-created intervention and serve as the study\'s intervention group.\n\nAdditionally, all women (both intervention and control group) will be interviewed in gestational week 32-36 and 8-12 weeks postpartum. Further, information about HbA1c, maternal BMI, gestational weight gain, mode of delivery, neonatal weight as well as obstetric and neonatal complications will be obtained from measurements and the delivery records. The primary endpoint will be large for gestational age. Secondary neonatal endpoints will be macrosomia, preterm birth, stillborn/neonatal death and neonatal hypoglycemia. Secondary maternal outcomes will be HbA1c, hypertensive disorders, gestational weight gain, caesarean section, women\'s GDM self-care, perceived social support, perceived wellbeing, signs of depression, breastfeeding rates, quality of life, and empowerment. The outcome of this intervention pilot study will determine whether the intervention can be feasibly delivered within the context of a full-scale randomized controlled trial (RCT). Thus, the pilot study will not be powered to detect statistical differences in key clinical outcomes, but the sample sizes have been chosen to highlight problems and confirm the potential to detect differences.\n\nWomen may be included in the study all the way up to gestational age 28 depending on when they attend their first antenatal care appointment and receive the OGTT. Further, the point in time of the different questionnaire interviews may vary according to the needs of the pregnant women and when she delivers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy \\< 28 weeks\n* Singleton and multiple pregnancies\n* Residing in Thai Binh province\n* Speaks and reads Vietnamese\n* Agree to participate voluntarily (informed consent)\n\nExclusion Criteria:\n\n* Pre-gestational diabetes (type I or type II)\n* Severe chronic disease\n\nWomen with GDM in a prior pregnancy are eligible for inclusion into the study.'}, 'identificationModule': {'nctId': 'NCT05744856', 'acronym': 'VALID-II', 'briefTitle': 'A Co-created Self-care and Informal Support Intervention Study Among Women With GDM in Vietnam', 'organization': {'class': 'OTHER', 'fullName': 'Thai Binh University of Medicine and Pharmacy'}, 'officialTitle': 'Living Together With Chronic Disease: Informal Support for Diabetes Management in Vietnam (VALID) - Gestational Diabetes in Vietnam - Phase II', 'orgStudyIdInfo': {'id': 'VALID II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard GDM care', 'description': "After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status).\n\nTreatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves."}, {'type': 'EXPERIMENTAL', 'label': 'Self-care with informal support', 'description': 'Standard care + "Self-care/informal support" intervention\n\nThe detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.\n\nIt is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.\n\nGDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.', 'interventionNames': ['Behavioral: Self-care with informal support']}], 'interventions': [{'name': 'Self-care with informal support', 'type': 'BEHAVIORAL', 'description': 'The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.\n\nIt is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.\n\nGDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.', 'armGroupLabels': ['Self-care with informal support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Thái Bình', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Pham Thi Kim Ngan, MD', 'role': 'CONTACT', 'email': 'phongkhamkimngan325pbv@gmail.com', 'phone': '(+84) 981 191 125'}], 'facility': 'Kim Ngan Clinic', 'geoPoint': {'lat': 20.45, 'lon': 106.34002}}, {'zip': '410000', 'city': 'Thái Bình', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Nguyen Thanh', 'role': 'CONTACT', 'email': 'bsthanh@hotmail.com', 'phone': '+84912357575'}, {'name': 'Lê Minh Hieu, MD', 'role': 'CONTACT', 'email': 'drhieuytb@gmail.com'}], 'facility': 'Thai Binh Maternity Hospital', 'geoPoint': {'lat': 20.45, 'lon': 106.34002}}], 'centralContacts': [{'name': 'Thanh Duc Nguyen, MD', 'role': 'CONTACT', 'email': 'bsthanh@hotmail.com', 'phone': '+84 091 235 7575'}, {'name': 'Lê Minh Hieu, MD', 'role': 'CONTACT', 'email': 'drhieuytb@gmail.com'}], 'overallOfficials': [{'name': 'Thanh Duc Nugyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thain Binh Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'The data will be available immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in the articles will be shared after de-identification (text, tables, figures, and appendices). Sharing of data must adhere to the General Data Protection Regulation (GDPR) in Denmark and Vietnam.', 'accessCriteria': 'All requests for data should be addressed to the sponsor (see contact details under central contact person). The sponsor will will review the request and involve all applicable parties in the decision-making outcome (i.e. all Vietnamese and Danish collaborators). Data will be shared with researchers who provide a methodological sound proposal. New projects that result in data sharing should meet the high standards (quality, ethical, and financial) maintained by this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thai Binh University of Medicine and Pharmacy', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of International Relations Department', 'investigatorFullName': 'Thanh Duc Nguyen', 'investigatorAffiliation': 'Thai Binh University of Medicine and Pharmacy'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-25', 'type': 'RELEASE'}, {'date': '2025-10-22', 'type': 'RESET'}, {'date': '2025-11-15', 'type': 'RELEASE'}, {'date': '2025-12-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Thanh Duc Nguyen, Head of International Relations Department, Thai Binh University of Medicine and Pharmacy'}}}}