Clinical trial NCT03997656: A Digital Therapy for Diabetes Prevention Among Overweight Adults in Terengganu, Malaysia
Official title: A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre Diabetes
Overweight and Obesity
Lead sponsor: Universiti Sultan Zainal Abidin
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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 at least once/day to the internet
* being fluent in Malay or English languages and
* had no contradictions to participate in weight management program or physical activity.

Exclusion Criteria:

* clinical history of diabetes or newly diagnosed diabetes at the time of screening where HbA1c level ≥45 mmol/mol or ≥6.3%
* taking oral anti-diabetic agents
* participating in a concurrent weight management program or interventional research protocol
* on a prescribed medical diet, anti-obesity or diabetes therapy within the preceding 4 months
* 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 the next 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 physically disabled)

Primary outcomes:
measure: body weight
timeFrame: 6-months and 12-months
Secondary outcomes:
measure: HbA1c level
timeFrame: 6-months and 12-months
measure: physical activity level
timeFrame: 6-months and 12-months
measure: dietary intake
timeFrame: 6-months and 12-months
measure: health-related quality of life
timeFrame: 6-months and 12-months
Other outcomes:
Locations:
city: Kuala Terengganu
country: Malaysia
facility: University Sultan Zainal Abidin
state: Terengganu
Study officials:
affiliation: Universiti Sultan Zainal Abidin
name: Sharifah Wajihah Wafa T Syed Saadun Tarek Wafa, PhD
role: PRINCIPAL_INVESTIGATOR
References: