The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors

Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05798442
• Other study ID #: Opulse app
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: March 2023
• Source: Sultan Qaboos University
• Contact: Amani Alkhaifi, PhD
• Phone: +96899245544
• Email: amani[@]squ.edu.om
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 410
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Hypercholesterolemia
• Hypertension
• Obesity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sultan Qaboos University	Ministry of Higher Education, Research and Innovation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced blood cholesterol and triglycerides levels	Immunoassay based-method will be used to measure lipid profile in the blood samples collected from the study participants. Lipids will be measured in millimole/Liter This outcome will be achieved when the Participants lipid profile is reduced compared to the initial values (measured at the beginning of the study); The assessment will be base don the ranges below: Total Cholesterol (mmol/L): < 5.2 / TG (mmol/L): (0 - 2.3) / LDL-C (mmol/L): < 2.59 / HDL-C (mmol/L): > 1.68 (Female) >1.45 (Male)	18 months
Primary	Reduced blood glucose levels	Glucometer devices for fasting blood glucose and for glycated hemoglobin will be used to asses the improvement in impaired glycemia.; Participants who achieve this outcome would have reduced blood glucose compared to the initial values (measured at the beginning of the study); The following measures will be used to asses the glycemic state of the pateints; Fasting blood glucose: (Norma < 5.6 mmol/L), (Impaired glycemia/type 2 diabetes = 5.6 mmol/L) Glycated hemoglobin (HbA1c): (Normal < 5.7 %), (> 6.5 Diabetes)	18 months
Primary	Normalized blood pressure	systolic blood pressure and diastolic blood pressure of the participants will measured throughout the study using sphygmomanometer; The measures below will be used to assess the improvement in the blood pressure of the participants Hypertension: systolic blood pressure = 130 mmHg and/or diastolic blood pressure = 85 mmHg Normal blood pressure: systolic: < 120 mm Hg/ diastolic < 80 mm Hg	18 months
Primary	Reduced BMI and visceral obesity	Anthropometric measurements (height, weight, waist and hip circumferences) will be taken from the participants throughout the study.; Body Mass Index (BMI) will be measured using the formula BMI = weight(kg)/height(m2).; Desired BMI is in the range of 18.5 to 24.9, A BMI of 25.0 or more is overweight; Visceral obesity will be assed by measuring the waist-to-hip ratio Female: > 0.85 No visceral obesity, < 0.85 existing visceral obesity Male: > 1.0 No visceral obesity, < 1.0 existing visceral obesity	18 months
Secondary	Increased physical activity and increased intake of healthy diet	The daily physical activity will will be measured by pedometer feature of the mobile application in the form of number of foot steps.; Intake of healthy diet will also be assessed using the mobile application by counting the number of vegetables/fruits servings per day.; The overall increase in the physical activity and intake of healthy diet will be assessed during the study visits (every 4 months) using a standardized validated questionnaires namely "Dubasi questionnaire on dietary intake and physical activity". This questionnaire is based on likert score (Dubasi, S.K., et al., Questionnaire to assess adherence to diet and exercise advices for weight management in lifestyle-related diseases. J Family Med Prim Care, 2019. 8(2): p. 689-694.)	18 months
Secondary	Reduced alcohol consumption and tobacco smoking	The reduction in alcohol consumption and tobacco smoking will be assessed using Standardized validated questionnaires The Fagerström test for Nicotine Dependence which asses the intensity of physical addiction to nicotine Alcohol Use Disorders Identification Test (AUDIT) questionnaire	18