A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Single-blinded approach
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
MyDipp
The participants will go through 16-weekly core lessons that need to be completed within the first 24 weeks after randomisation focusing on changing dietary habits, increase physical activity and relapse prevention and 6-monthly post-core lessons focusing on maintenance of lifestyle habits and weight loss achieved during the core program. Each lesson will take 30 to 60 minutes to complete. The lesson will be considered complete if the participants clicked through all of the pages and answered multiple choice questions to indicate engagement and understanding.
干预措施: MyDiPP (Malaysia Diabetes Prevention Program) (Behavioral)
Control
Participants in the control group (usual care) will receive standard health education from primary care providers in the clinic. In addition, they also will be provided with pamphlets and booklets about various health topics. They will be given a diary to record their weights, diet, physical activities and blood test result.
干预措施: usual care (Other)
结局指标
主要结局
body weight
时间窗: 6-months and 12-months
change of the initial body weight by 5% to 7%
次要结局
- physical activity level(6-months and 12-months)
- health-related quality of life(6-months and 12-months)
- dietary intake(6-months and 12-months)
- HbA1c level(6-months and 12-months)