[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500606":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":18,"responsibleParty":37,"collaborators":40,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":18,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":18,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":71,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":18},{"fullName":5,"class":6},"Sultan Qaboos University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"mHealth app-based intervention group","EXPERIMENTAL","The app-based intervention group will be given access to a mHealth app that will be specifically designed to motivate the users to increase their physical activity and healthy diet intake while reducing smoking and alcohol intake. The app provides the patients with standardized dietary and exercise guidelines and sends them frequent advice and reminders to follow the guidelines. Changes in the CVD risk factors of the participants will be assessed based on blood biochemical and anthropometric measurements collected every 4 months over a period of 20 months. The app will be designed to include interactive functions which allow the patients to insert their daily caloric intake and exercise, biometric data, track the improvement in their CVD risk factors and CVD risk score.",[13],"Other: smartphone health application (Opulse)",{"label":15,"type":16,"description":17,"interventionNames":18},"face-to-face consultation group","NO_INTERVENTION","This group of patients will not have access to mHealth app and will receive the traditional face to face intervention.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"smartphone health application (Opulse)","The Opulse app will be designed as a multifunction app that targets the modification of the behavioral and metabolic risk factors and provides comprehensive interventions for healthy diet, physical activity and smoking cessation among smokers.",[9],[25],{"name":26,"affiliation":5,"role":27},"Amani Alkhaifi, PhD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","+96899245544","amani@squ.edu.om",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Hana Alsumri, PhD","+96895085861","alsumry@squ.edu.om",{"type":27,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Dr. Amani Alkhaifi","Principal Investigator",[41],{"name":42,"class":43},"Ministry of Higher Education, Research and Innovation","AMBIG","100500606","the-impact-of-using-a-smartphone-health-application-in-the-improvement-of-cardiovascular-disease-risk-factors-100500606",false,"NCT05798442","The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors","The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors in the Omani Population; Prospective Randomized Clinical Trial","Inclusion Criteria:\n\n* Presentation with at least one of the following metabolic abnormalities:\n* Hypertensions (systolic blood pressure ≥ 130 mmHg and\u002For diastolic blood pressure ≥ 85 mmHg)\n* Obesity (waist circumference ≥ 80 cm (women) or ≥ 94 cm (men) and BMI ≥ 25 kg\u002Fm2)\n* Dyslipidemia (triglycerides ≥ 1.7 mmol\u002FL or\u002Fand HDL-cholesterol ≤ 1.29 mmol\u002FL (women) or ≤ 1.02 mmol\u002FL (men) or\u002Fand LDL-Cholesterol \\> 5.18 mmol\u002FL, serum total cholesterol ≥ 5.2 mmol\u002Fl)\n* Impaired glycemia\u002Ftype 2 diabetes (fasting plasma glucose ≥ 5.6 mmol\u002FL)\n* Arabic or English language speaking and able to read and write in one of these languages\n* Possession of a smart mobile phone Willing to utilize a mobile application for CVD management.\n\nExclusion Criteria:\n\n* A history of stroke, myocardial infarction or any related cardiovascular complications Complicated diabetes mellitus e.g., Proliferative diabetic retinopathy, end-stage renal disease\n* Unavailability of a smartphone or any reason that will not allow the participant to use the app properly. (such as; difficulty or inability to use mobile applications, unavailability of network services…etc.).\n* Medical conditions that restrain the participant to be physically active.\n* High chance of loss to follow up at the FAMCO clinic (due to upcoming travel, temporary employment and thus eligibility to be treated at the clinic, irregular visits due to distance from home…etc.)","ALL","18 Years","55 Years",{"count":55,"type":56},410,"ESTIMATED","INTERVENTIONAL",[59],"NA","This study investigates the effectiveness of Mobile health application (mHealth apps) in the improvement of cardiovascular disease risk factors including metabolic and behavioral factors. The app will be tested on patients with any of the modifiable risk factors of CVD such as hypertension, obesity, hyperlipidemia, and impaired glycemic control\u002Ftype 2 diabetes mellitus .",[62,63,64,65],"Hypercholesterolemia","Obesity","Diabetes Mellitus","Hypertension",[67,68,69,70],"Mobile health application","Cardiovascular disease prevention","Metabolic risk factors","Behavioral risk factors","NOT_YET_RECRUITING","2023-03-23",{"date":74,"type":75},"2023-04-04","ACTUAL",{"date":77,"type":56},"2024-01-30",{"date":79,"type":56},"2027-12-30",{"name":5,"class":6}]