Clinical trial NCT05798442: The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors
Official title: The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors in the Omani Population; Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypercholesterolemia
Obesity
Diabetes Mellitus
Hypertension
Keywords: Mobile health application
Cardiovascular disease prevention
Metabolic risk factors
Behavioral risk factors
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
Collaborators: name: Ministry of Higher Education, Research and Innovation
First posted: 2023-04-04
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with cardiovascular disease risk factors will be blindly randomized into two groups in a ratio of (1:1); mHealth app-based intervention group and a traditional mainstream face-to-face consultation group. 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.
Primary purpose: PREVENTION

Brief summary: 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/type 2 diabetes mellitus .

Detailed description: The investigators aim in this study to reduce the risk of cardiovascular disease in patients with hypercholesterolemia, diabetes, obesity and hypertension. This will be achieved by motivating healthy lifestyle among the participants such as increasing physical activity and intake of healthy diet and reducing alcohol and tobacco consumption. The tool which will be used to motivate healthy lifestyle is a smartphone application which will be specifically designed to motivate behavioral change. Thus, the investigators hypothesis is that participants who have full access to the mobile application will show improved healthy lifestyle, reduced blood pressure, cholesterol and glucose and reduced BMI compared to the participants who don't have access to the mobile application.

Eligibility criteria: Inclusion Criteria:

* Presentation with at least one of the following metabolic abnormalities:
* Hypertensions (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg)
* Obesity (waist circumference ≥ 80 cm (women) or ≥ 94 cm (men) and BMI ≥ 25 kg/m2)
* Dyslipidemia (triglycerides ≥ 1.7 mmol/L or/and HDL-cholesterol ≤ 1.29 mmol/L (women) or ≤ 1.02 mmol/L (men) or/and LDL-Cholesterol \> 5.18 mmol/L, serum total cholesterol ≥ 5.2 mmol/l)
* Impaired glycemia/type 2 diabetes (fasting plasma glucose ≥ 5.6 mmol/L)
* Arabic or English language speaking and able to read and write in one of these languages
* Possession of a smart mobile phone Willing to utilize a mobile application for CVD management.

Exclusion Criteria:

* A history of stroke, myocardial infarction or any related cardiovascular complications Complicated diabetes mellitus e.g., Proliferative diabetic retinopathy, end-stage renal disease
* 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.).
* Medical conditions that restrain the participant to be physically active.
* 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.)

Primary outcomes:
measure: Reduced blood cholesterol and triglycerides levels
timeFrame: 18 months
measure: Reduced blood glucose levels
timeFrame: 18 months
measure: Normalized blood pressure
timeFrame: 18 months
measure: Reduced BMI and visceral obesity
timeFrame: 18 months
Secondary outcomes:
measure: Increased physical activity and increased intake of healthy diet
timeFrame: 18 months
measure: Reduced alcohol consumption and tobacco smoking
timeFrame: 18
Other outcomes:
Locations:
Study officials:
affiliation: Sultan Qaboos University
name: Amani Alkhaifi, PhD
role: PRINCIPAL_INVESTIGATOR
References: