Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT05798442

Opening soonNot applicableInterventional

What this study is about

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 .

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years

SexAll

Healthy volunteersNot accepted

ConditionHypercholesterolemia, Obesity, Diabetes Mellitus, Hypertension

Full registry 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.)

Treatments and study arms

smartphone health application (Opulse)

Other

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.

Primary outcomes

Reduced blood cholesterol and triglycerides levels18 months

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)

Reduced blood glucose levels18 months

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)

Normalized blood pressure18 months

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

Reduced BMI and visceral obesity18 months

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

Study locations

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No public site location was included in this record. Check the original registry for updates.