HypercholesterolemiaNCT05798442
The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors
A study testing smartphone health application (Opulse) in people with Hypercholesterolemia and Obesity, run by Sultan Qaboos University.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypercholesterolemia, Obesity, Diabetes Mellitus
- What is being tested?
- smartphone health application (Opulse)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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 .
Read the 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.
- Conditions
- Hypercholesterolemia, Obesity, Diabetes Mellitus, Hypertension
- Being tested
- smartphone health application (Opulse)
- Keywords
- Mobile health application, Cardiovascular disease prevention, Metabolic risk factors, Behavioral risk factors
- Medical subject headings
- Hypercholesterolemia, Obesity, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: smartphone health application (Opulse) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months
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)
Measured: 18 months
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
Measured: 18 months
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
Measured: 18 months
Secondary outcomes (2)
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.)
Measured: 18 months
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
Measured: 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start30 Jan 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Research and Innovation
- Responsible party
- Principal investigator, Dr. Amani Alkhaifi, Sultan Qaboos University
- Investigators
- Amani Alkhaifi, PhD, Principal investigator, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798442
- Sponsor's protocol ID
- Opulse app
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05798442
- Acronym / sponsor ID
- Opulse app
- Conditions
- Hypercholesterolemia, Obesity, Diabetes Mellitus, Hypertension
- Keywords
- Mobile health application, Cardiovascular disease prevention, Metabolic risk factors, Behavioral risk factors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Research and Innovation
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| mHealth app-based intervention group | Experimental | Other: smartphone health application (Opulse)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. |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | mHealth app-based intervention group |
Primary outcome
Reduced blood cholesterol and triglycerides levels
Time frame: 18 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 levels
Time frame: 18 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 pressure
Time frame: 18 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 obesity
Time frame: 18 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
2 secondary outcomes
Increased physical activity and increased intake of healthy diet
Time frame: 18 months
Reduced alcohol consumption and tobacco smoking
Time frame: 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amani Alkhaifi, PhD principal investigator
Sultan Qaboos University
Questions about this trial
What is this clinical trial studying?
A study testing smartphone health application (Opulse) in people with Hypercholesterolemia and Obesity, run by Sultan Qaboos University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amani Alkhaifi, PhD (+96899245544, amani@squ.edu.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced blood cholesterol and triglycerides levels (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.