Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Overweight and Obesity
  • Pre Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Control groupMasking: Single (Investigator)Masking Description: Single-blinded approachPrimary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Digital therapy is a new field that has emerged as the evidence-based treatments from the field of behavioural medicine that are delivered online. It is considered as a scalable method to reach a large number of at-risk population, convenient and accessible. Furthermore, it frees participants from t...

Digital therapy is a new field that has emerged as the evidence-based treatments from the field of behavioural medicine that are delivered online. It is considered as a scalable method to reach a large number of at-risk population, convenient and accessible. Furthermore, it frees participants from the requirement of travelling to a specific location and more flexible with the time to participate. The aim of this study therefore to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in adults at risk of developing diabetes, an assessor-blinded, parallel-group, randomised controlled trial using the MyDiPP (Malaysia Diabetes Prevention Programme) app. Eligible participants were stratified (age, BMI) and then randomised in a 1:1 ratio to either the 12-month MyDiPP intervention or receive standard health education from primary care providers in the clinic. The study will be conducted in two phases. The first phase will involve preparation of intervention modules, development of intervention mobile app, training and recruitment of participants. The second phase of the study will involve implementation of the intervention, data collection, follow up and data analyses. The study will be conducted in individuals aged 18- to 65-years old, living, working or studying in Kuala Terengganu who is at risk developing diabetes but currently does not have diabetes recruited through online advertisement. The target population is adult residents that lived, worked or studied in Kuala Terengganu who is identified as being at high risk of type 2 diabetes. One hundred participants will be recruited for this study. They will be identified by a two-stage screening process. In the first stage, patients at high risk of type 2 diabetes will be identified via the CDC Diabetes Risk Test that will be distributed via Google Form. The researcher will invite those who scored ?5 for second stage screening test via the HbA1c test. In the second stage, patients attending a screening for eligibility who have a current HbA1c in the range 38-44 mmol/mol or 5.6-6.2% will be invited to volunteer.

Tracking Information

NCT #
NCT03997656
Collaborators
Not Provided
Investigators
Principal Investigator: Sharifah Wajihah Wafa T Syed Saadun Tarek Wafa, PhD Universiti Sultan Zainal Abidin