Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT06847633
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-17', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-cholesterol', 'timeFrame': '6 months post-randomization', 'description': 'Low density lipoprotein cholesterol'}], 'secondaryOutcomes': [{'measure': 'HDL-cholesterol', 'timeFrame': '6 months post-randomization', 'description': 'High density lipoprotein cholesterol'}, {'measure': 'Total cholesterol', 'timeFrame': '6 months post-randomization'}, {'measure': 'Fasting blood glucose', 'timeFrame': '6 months post-randomization'}, {'measure': 'Triglycerides', 'timeFrame': '6 months post-randomization'}, {'measure': 'Non-HDL cholesterol', 'timeFrame': '6 months post-randomization', 'description': 'Calculated by subtracting HDL cholesterol from total cholesterol'}, {'measure': 'Systolic blood pressure', 'timeFrame': '6 months post-randomization'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '6 months post-randomization'}, {'measure': 'Weight', 'timeFrame': '6 months post-randomization'}, {'measure': 'Height', 'timeFrame': '6 months post-randomization'}, {'measure': 'Body mass index', 'timeFrame': '6 months post-randomization'}, {'measure': 'Waist circumference', 'timeFrame': '6 months post-randomization'}, {'measure': 'Systematic COronary Risk Evaluation model, second version (SCORE2)', 'timeFrame': '6 months post-randomization', 'description': 'Estimated percentage risk of fatal and non-fatal cardiovascular disease within the next 10 years. The estimation is based on data on sex, age, smoking, systolic blood pressure (SBP), total cholesterol, and HDL cholesterol'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 months post-randomization', 'description': "Measured by the questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L). Five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response options, scored 1-5, ranging from 'no problems' to 'extreme problems'"}, {'measure': 'Health-related quality of life', 'timeFrame': '6 months post-randomization', 'description': 'Measured by the questionnaire EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) visual analogue scale (VAS) ranging from 0 to 100 where higher values represents better self-assessed health.'}, {'measure': 'Diet intake', 'timeFrame': '6 months post-randomization', 'description': 'Assessed by questions on intake quantity of vegetables, fruit, sweet beverages, and snacks the past week'}, {'measure': 'Physical activity', 'timeFrame': '6 months post-randomization', 'description': 'Assessed by questions on time (minutes and hours) spent in moderate and vigorous physical activity the past week'}, {'measure': 'Sedentary time', 'timeFrame': '6 months post-randomization', 'description': 'One question about time in sitting position'}, {'measure': 'Stress', 'timeFrame': '6 months post-randomization', 'description': 'Assessed by the Perceived Stress Scale. Minimum value 0. Maximum value 56. Higher scores indicating greater perceived stress.'}, {'measure': 'Sleep', 'timeFrame': '6 months post-randomization', 'description': 'Assessed by the Karolinska Sleep Questionnaire. No single set of minimum and maximum values. Each item is scored from 0-5, where higher values indicate greater sleep issues'}, {'measure': 'Alcohol consumption', 'timeFrame': '6 months post-randomization', 'description': 'Questions on monthly frequency of heavy episodic drinking, weekly alcohol consumption'}, {'measure': 'Tobacco use', 'timeFrame': '6 months post-randomization', 'description': 'Questions on frequency of smoking and using snus the past week and the past 4 weeks'}, {'measure': 'Mediated effects on behavior change', 'timeFrame': '6 months post-randomization', 'description': 'Potential mediators to be assessed are confidence, importance, and know-how (i.e., knowing how to change a behavior).'}, {'measure': 'Participant experience from using the digital intervention', 'timeFrame': '6 months post-randomization', 'description': "Questions on experience from using the intervention (intervention group only). The questions are framed as statements with five response options ranging from 'Not agreeing at all' to 'Fully agreeing'"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Lifestyle Factors']}, 'descriptionModule': {'briefSummary': 'Unhealthy lifestyle behaviors are well-established risk factors for cardiovascular disease (CVD) which is the leading cause of death globally and in Sweden. Digitalization offers new and better possibilities for healthcare to fulfil their responsibility to support healthier lifestyles, however, to ensure scalability and sustained implementation of digital tools within healthcare, digital interventions need to be systematically maintained and delivered by the primary healthcare. The aim of this project is to evaluate whether a digital lifestyle intervention, developed within Swedish primary healthcare, can improve clinically important cardiovascular health outcomes and lifestyle behaviors. In this multi-center randomized controlled trial patients, 40-60 years, in Swedish primary healthcare will be recruited and randomized to the control or intervention group. All participants will receive standard care consisting of one structured health dialogue focused on lifestyle habits. The intervention group will also receive support through the digital lifestyle intervention for creating healthy habits regarding diet, physical activity, alcohol consumption, and tobacco usage. The primary outcome is LDL-cholesterol at 6 months post-randomization. Secondary outcomes 6 months post-randomization are HDL-, total cholesterol, fasting blood glucose, triglycerides, non-HDL, blood pressure, weight, height, BMI, waist circumference, cardiovascular risk evaluation (SCORE2), dietary intake, physical activity, sleep, stress, alcohol consumption, tobacco use, and health-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '39 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attended a Health dialogue visit to primary healthcare for patients 40-60 years old\n* Willing to change at least one lifestyle behavior regarding physical activity, diet, smoking/snus, alcohol, sleep, or stress\n\nExclusion Criteria:\n\n* diabetes\n* heart failure\n* history of myocardial infarction\n* history of stroke\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT06847633', 'briefTitle': 'A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease', 'orgStudyIdInfo': {'id': '2024-07911-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital lifestyle intervention', 'description': 'Access to the digital intervention which will provide support for healthier lifestyle behaviors regarding diet, physical activity, sleep, stress, alcohol consumption, and use of tobacco.', 'interventionNames': ['Behavioral: Digital lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Standard care i.e., a routine appointment to the primary healthcare center for discussing lifestyle habits'}], 'interventions': [{'name': 'Digital lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'The digital lifestyle intervention provides support to the patient through digital lectures, home assignments and digital group meetings as well as provides the possibility for the healthcare provider to provide personalized digital support and feedback to the patient', 'armGroupLabels': ['Digital lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gävle', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'facility': 'Primary helathcare centers in Region Gävleborg', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'city': 'Halmstad', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Primary healthcare centers in Region Halland', 'geoPoint': {'lat': 56.67446, 'lon': 12.85676}}, {'city': 'Linköping', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'facility': 'Primay healthcare centers in Region Östergötland', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Malmo', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'role': 'CONTACT', 'phone': '+46702473149'}], 'facility': 'Primary healthcare centers in region Skåne', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Umeå', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'facility': 'Primary healthcare centers in Region Västerbotten', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Västerås', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Primary healthcare centers in Region Västmanland', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'centralContacts': [{'name': 'Linnea Hedin, PhD', 'role': 'CONTACT', 'email': 'linnea.hedin@ki.se', 'phone': '+4670-2473149'}], 'overallOfficials': [{'name': 'Marie Löf, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Capio Narsjukvard', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marie Löf, docent', 'investigatorAffiliation': 'Karolinska Institutet'}}}}