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Clinical Trials/CTRI/2024/11/076715
CTRI/2024/11/076715Not yet recruitingPhase 2

Effectiveness of Technology Empowered App on Cardiovascular Health and Health Literacy among young adults studying in health professional colleges of Udupi Taluk, Karnataka- A Cluster Randomized Controlled Trial.

Charlet Jasmine Vaz1 site in 1 country800 target enrollmentStarted: December 2, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
800
Locations
1
Primary Endpoint
optimal cardiovascular health

Study Overview

Brief Summary

A Cluster randomized controlled trial to assess the effectiveness of technology empowered app on Cardiovascular health and health literacy among young adults studying in health professional colleges of Udupi Taluk, Karnataka**.** The study has 2 phases, Phase 1, cardiovascular health of young adults will be assessed using tool to assess cardiovascular health. The development of technology empowered app will be done in phase 1. Phase 2 those young adults who are screened to have suboptimal cardiovascular health will be assigned to intervention and control group. the control group will receive onsite awareness program, while the intervention group will receive app and onsite awareness programme. Both groups will be followed at baseline, 3 months, 6 months, and 12 months. 

The objectives of the study are

Phase I

Develop and validate the Technology Empowered App on Cardiovascular Health among young adults of health professional colleges.

Assess the cardiovascular health among the young adults of health professional colleges.

Determine the cardiovascular health literacy among the young adults of health professional colleges.

Phase II

Find the effectiveness of the App on cardiovascular health and health literacy among the subjects in the experimental group as compared to the control group at baseline, three, six, and twelve months.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 25.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Phase I: Young adults studying in health professional colleges between 18-25 years of age Phase II: Young adults studying in health professional colleges screened to have suboptimal cardiovascular health during Phase I, having android mobile phones, who are consenting for blood lipids and HbA1c investigation.

Exclusion Criteria

  • Young adults previously diagnosed to have Coronary Artery Disease, Ischemic Heart Disease, Diabetes Mellitus and HbA1c more than 7, Blood pressure level more than 160 and 100, Non HDL more than 220, and on treatment.
  • on treatment for weight reduction, Polycystic Ovarian Disease following any dietary regimens or health plans or using any health apps not available during the data collection period.

Outcomes

Primary Outcomes

optimal cardiovascular health

Time Frame: at baseline, 3month, 6 month and 12 months

Secondary Outcomes

  • Cardiovascular Health literacy(at baseline, 3month, 6 month and 12 months)

Investigators

Sponsor
Charlet Jasmine Vaz
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Charlet Jasmine Vaz

Manipal College of Nursing

Study Sites (1)

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