None listed
Conditions
Brief summary
The increasing prevalence of chronic diseases in general and diabetes mellitus in particular, is a major health concern in Singapore and many countries around the world. According to National Health Survey in 2010, the prevalence of diabetes has increased, with 25.7% of Singapore's adult population aged 18-69 years having diabetes or pre-diabetes. The rapidly aging population will further add on to the burden on healthcare resources. The burden of diabetes extends beyond physiological abnormalities like high blood glucose, to the impact on quality of life associated with uncontrolled or untreated diabetes. Diabetes complications are irreversible and range from coronary heart disease, renal failure, blindness, limb amputations and many other end organ complications. The current treatment of diabetes is often reactive, and is managed at a later disease stage. With late detection and management, health complications may have already set in. Management of diabetes needs to move upstream, to prevent the progression of disease and also to manage it well enough to prevent further complications. Lifestyle intervention is first-line strategy in the prevention and management of pre-diabetes and diabetes. In a landmark study known as Diabetes Prevention Programme (DPP), it was shown that lifestyle intervention reduced the incidence of diabetes by 58% and metformin by 31%, as compared with placebo. In another study of 4503 U.S. adults with body mass index of 25 or higher and type 2 diabetes, an intensive lifestyle intervention was associated with a higher rate of remission of diabetes. As a result, there is a surge of programmes targeting on diet and physical activities in the States and all over the world. An economic review of 28 studies in the U.S shows that combined diet and physical activity promotion programmes for people at increased risk for type 2 diabetes are cost effective. Lifestyle intervention programmes commonly incorporate diet, exercise, behaviour modifications, dietitian or exercise therapist consultations (or both), and an individualised diet or exercise plan (or both). The success of the treatment is associated with the intensity of lifestyle measures, leading to greater weight loss in those who are overweight or obese and reduction in newly onset diabetes. However, current methods of delivering these interventions are not scalable to the at-risk population as it is costly, time consuming and has high default rate post screening. At present, mobile technology-enabled modality of treatment to facilitate lifestyle interventions has not been studied locally for diabetes and other chronic diseases. The study hypothesis is that a locally developed and targeted mobile application, combined with remote coaching, will be able to effect positive changes in health related behaviours and lifestyle choices, prevent and manage diabetes, and ultimately improving health outcomes and save healthcare costs.
Interventions
Our study makes use of a targeted and locally customized smartphone mobile application (nBuddy Diabetes), implemented to promote lifestyle modifications for diabetes prevention and control. The program's effectiveness and efficacy in early diabetics and pre-diabetics will be studied in this randomised controlled trial.
The first study visit can be conducted individually or as a group workshop by a dietitian at National University Hospital, depending on the recruitment numbers. The experiment g
Our study makes use of a targeted and locally customized smartphone mobile application (nBuddy Diabetes), implemented to promote lifestyle modifications for diabetes prevention and control. The program's effectiveness and efficacy in early diabetics and pre-diabetics will be studied in this randomised controlled trial. The first study visit can be conducted individually or as a group workshop by a dietitian at National University Hospital, depending on the recruitment numbers. The experiment group will be taught on using the smartphone mobile application which targets on diet and exercise interventions. They will be guided to achieve their individualised goals using in-built evidence based behaviour modification tool. These are implemented as daily tips, prompters and decision-support system to motivate participants towards their weight goal and blood glucose control. Participants can also review their progress via the weight, calorie intake, physical activity and blood glucose charts in the application. The visit will include education on the basics of diabetes management or prevention by the dietitian, which can take up to 45 minutes. During the 6 months' intervention period, participants will be required to input their daily food intake, exercise, weekly weight and blood glucose readings via the application. To facilitate self-monitoring at home, they will each be issued with weighing scale and glucometer at their first study visit. Through the application, they will receive remote monitoring and targeted advice from the dietitian. The application will provide participants with real-time decision-support response if the food selected is not the best choice for him or her. Educational videos on diabetes and pre-diabetes management will be sent to participants weekly via the application. The videos will cover various topics such as "What can you do to control diabetes", "Counting carbohydrates made easy", "Building your support channel for successful diabetes control", and "Exercise to manage diabetes". Two optional group workshops within the study period will be conducted to enhance the intervention - (i) Behavioural Strategies, inclusive of a Supermarket Tour, (ii) Sustenance of Results. These workshops range from 1 to 2 hours and will be conducted by a dietitian. The application, intervention and the remote coaching within the study period are provided for the participants at no cost. The dietitian will monitor progress of participants via a dashboard, tracking participants' daily food intake and exercise, weekly weight, and blood glucose readings for the diabetics arm. The research team will touch base and provide coaching to the patients via the chat feature of the application. From the dashboard of the mobile application, the research team will be able to evaluate the participants in the intervention group on the following: - login access rate and usage pattern of the application - food choices and nutrients intake - activities / exercise level - user's responses to health recommendations - user preferences - actions taken by users - strategies that are effective - records of progress and outcomes for weight, BMI, blood glucose, calorie intake, other nutrients intake, exercise - identifying patterns and correlations - favourite discussion topics - effect of buddy support system within the application and amount of support sourced from family or friends - frequency of slipping from the plan
Sponsors
Lim Su Lin
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants will be eligible for the study if they meet the following criteria: - Adults between 21 to 75 years old identified during community health screening or by doctors as having pre-diabetes (FBG = 6.1 - 6.9 mmol/L or Impaired Glucose Tolerance) or Type 2 diabetes (FBG equal or greater than 7.0 mmol/L or known diabetes based on OGTT) - Body Mass Index (BMI) of 23 kg/m2 or higher - Owns a smartphone with data plan - English speaking
Exclusion criteria
Participants will be excluded if they have: - known severe cognitive or psychological disabilities - heart failure - stage 4 and above kidney disease - untreated hypothyroidism - depression - Type 1 Diabetes - pregnant - non-resident - not keen to participate - Type 2 Diabetes on insulin - non-compliance to diabetic medications - untreated anemia, thalassemia or other blood disorder - have hbA1c readings that do not correspond to the other blood glucose measurements, as clinically assessed by the investigators.
Outcome results
None listed