NCT05798442

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 .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2024

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jan 2024Dec 2027

First Submitted

Initial submission to the registry

March 12, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

March 12, 2023

Last Update Submit

March 23, 2023

Conditions

HypercholesterolemiaObesityDiabetes MellitusHypertension

Keywords

Mobile health applicationCardiovascular disease preventionMetabolic risk factorsBehavioral risk factors

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Increased physical activity and increased intake of healthy diet

    18 months

  • Reduced alcohol consumption and tobacco smoking

    18

Study Arms (2)

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.

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.

Interventions

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.

mHealth app-based intervention group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypercholesterolemiaObesityDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Amani Alkhaifi, PhD

    Sultan Qaboos University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amani Alkhaifi, PhD

CONTACT

+96899245544amani@squ.edu.om

Hana Alsumri, PhD

CONTACT

+96895085861alsumry@squ.edu.om

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2023

First Posted

April 4, 2023

Study Start

January 30, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share