Back to resultsThe Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors
Primary Purpose
Hypercholesterolemia, Obesity, Diabetes Mellitus
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
smartphone health application (Opulse)
Sponsored by
About this trial
This is an interventional prevention trial for Hypercholesterolemia focused on measuring Mobile health application, Cardiovascular disease prevention, Metabolic risk factors, Behavioral risk factors
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.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mHealth app-based intervention group
face-to-face consultation group
Arm Description
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.
This group of patients will not have access to mHealth app and will receive the traditional face to face intervention.
Outcomes
Primary Outcome Measures
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)
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)
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
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
Secondary Outcome Measures
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.)
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
Full Information
NCT ID
NCT05798442
First Posted
March 12, 2023
Last Updated
March 23, 2023
Sponsor
Sultan Qaboos University
Collaborators
Ministry of Higher Education, Research and Innovation
1. Study Identification
Unique Protocol Identification Number
NCT05798442
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 30, 2024 (Anticipated)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sultan Qaboos University
Collaborators
Ministry of Higher Education, Research and Innovation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Obesity, Diabetes Mellitus, Hypertension
Keywords
Mobile health application, Cardiovascular disease prevention, Metabolic risk factors, Behavioral risk factors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mHealth app-based intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
face-to-face consultation group
Arm Type
No Intervention
Arm Description
This group of patients will not have access to mHealth app and will receive the traditional face to face intervention.
Intervention Type
Other
Intervention Name(s)
smartphone health application (Opulse)
Intervention Description
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 Outcome Measure Information:
Title
Reduced blood cholesterol and triglycerides levels
Description
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)
Time Frame
18 months
Title
Reduced blood glucose levels
Description
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)
Time Frame
18 months
Title
Normalized blood pressure
Description
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
Time Frame
18 months
Title
Reduced BMI and visceral obesity
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Increased physical activity and increased intake of healthy diet
Description
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.)
Time Frame
18 months
Title
Reduced alcohol consumption and tobacco smoking
Description
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
Time Frame
18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amani Alkhaifi, PhD
Phone
+96899245544
Email
amani@squ.edu.om
First Name & Middle Initial & Last Name or Official Title & Degree
Hana Alsumri, PhD
Phone
+96895085861
Email
alsumry@squ.edu.om
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amani Alkhaifi, PhD
Organizational Affiliation
Sultan Qaboos University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors
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