A Digital Therapy for Diabetes Prevention Among Overweight Adults in Terengganu, Malaysia

Phase

N/A

Condition

Obesity

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT03997656

2018/77

Ages 18-65
All Genders

Study Summary

The modern world revolves around technology; unsurprisingly companies are leveraging the expertise of the digital tech industry to aid in the prevention of chronic diseases. Among one of the most common chronic diseases in Malaysia is diabetes. Prevalence of diabetes in Malaysia has increased by more than two folds over the past two decades. Despite a growing number of tech products developments on diabetes prevention, a recent meta-analysis has found almost no evidence on digital therapy outside the developed world. Therefore, this study is needed to demonstrate the potential of digital therapy in preventing diabetes in Malaysia. The study design is a randomized controlled trial study conducted in Kuala Terengganu, Malaysia. The study will be conducted in two phases. The first phase will involve preparation of intervention modules and development of intervention mobile app. The second phase will involve validation and utilization of the digital therapy. We hope that this digital therapy program can make a significant difference in health outcomes, especially for diabetes. By giving precise regimes and daily monitoring, digital therapeutics can offer mountains of data that can potentially provide doctors unprecedented insights into patient behavior and create feedback or optimization loops for individual patients. Enabling patients to take greater control over managing their chronic illnesses and preventing disease progression could save billions of ringgits throughout the entire Malaysia healthcare system. By that, we hope this approach can be considered as a scalable solution to address national diabetes prevention efforts to target of improvement on diabetes prevalence to not more than 15% by 2025 and serve as a model for applying such services to other chronic diseases.

Eligibility Criteria

Inclusion

Inclusion Criteria:

aged 18-65 years old
body mass index (BMI) of ≥23 kg/m2,
high risk for diabetes (diabetes risk test score ≥5 [22] or HbA1c of 38-44 mmol/mol or 5.6-6.2%
ownership of a smartphone (Android only) for communication defined as logging on atleast once/day to the internet
being fluent in Malay or English languages and
had no contradictions to participate in weight management program or physicalactivity.

Exclusion

Exclusion Criteria:

clinical history of diabetes or newly diagnosed diabetes at the time of screeningwhere HbA1c level ≥45 mmol/mol or ≥6.3%
taking oral anti-diabetic agents
participating in a concurrent weight management program or interventional researchprotocol
on a prescribed medical diet, anti-obesity or diabetes therapy within the preceding 4months
had clinical history of cardiovascular diseases occurred within the past 6 months
any form of cancers that require treatment
dementia or probable Alzheimer's disease
advanced arthritis
pregnant or within 6 weeks of having given birth or planning to become pregnant in thenext 12 months
existing liver and renal disease and having hyperthyroidism
any mental health condition including eating disorder or alcohol/substance use
other causes which could interfere with participation (for examples physicallydisabled)

Study Design

September 01, 2019

July 01, 2021

Study 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 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.

Connect with a study center

University Sultan Zainal Abidin
Kuala Terengganu, Terengganu 20050
Malaysia
Active - Recruiting

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