Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001112358
Ethics application status
Approved
Date submitted
10/07/2017
Date registered
28/07/2017
Date last updated
13/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a smartphone mobile application and remote program for improving management and prevention of early diabetes and pre-diabetes (D'LITE Study - Diabetes Lifestyle Intervention using Technology Empowerment)
Scientific title
Smartphone Mobile App and Remote Programme in Behavioural, Diet and Lifestyle Interventions for Prevention and Management of Early Diabetes and Pre-Diabetes. (D'LITE Study - Diabetes Lifestyle Intervention using Technology Empowerment)
Secondary ID [1] 292158 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 303597 0
prediabetes 303598 0
obesity 303599 0
Condition category
Condition code
Diet and Nutrition 303008 303008 0 0
Obesity
Metabolic and Endocrine 303009 303009 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 298318 0
Prevention
Intervention code [2] 298319 0
Lifestyle
Intervention code [3] 298320 0
Behaviour
Comparator / control treatment
Participants randomised in the control arm will receive standard care. For those who have been diagnosed with diabetes or pre-diabetes during health screening, the current standard care is either advice given be a General Practitioner (GP) or a referral to the dietitian by the GP or management of care at the Polyclinics. The time taken for the clinic visit depends on the various healthcare professionals within the primary healthcare network. They will be issued a pamphlet on "Diet Management for Diabetes" or "Diet Management For Pre-Diabetes" (an in-house pamphlet, produced by Dietetics department at National University Hospital), during their first study visit by the research team,
Control group
Active

Outcomes
Primary outcome [1] 302404 0
Weight loss. Measured in kilograms using digital weighing scales.
Timepoint [1] 302404 0
Measured at baseline, 3 months, 6 months, 12 months and 24 months after study recruitment compared with baseline
Secondary outcome [1] 335871 0
Calculated Body Mass Index (BMI) in kilograms per square meter
Timepoint [1] 335871 0
Measured at baseline, 3 months, 6 months, 12 months and 24 months after study recruitment compared with baseline
Secondary outcome [2] 335873 0
Change in HbA1c, measured using whole blood sample collected in EDTA tube.
Timepoint [2] 335873 0
Measured at baseline, 3 months, 6 months, 12 months and 24 months after study recruitment compared with baseline
Secondary outcome [3] 335874 0
Change in fasting blood glucose, measured using fluoride tube.
Timepoint [3] 335874 0
Measured at baseline, 3 months, 6 months, 12 months and 24 months after study recruitment compared with baseline
Secondary outcome [4] 335880 0
Change in lipid panel (total cholesterol, triglycerides, LDL, HDL), measured by using whole blood sample collected in plain tube
Timepoint [4] 335880 0
Measured at baseline, 3 months, 6 months, 12 months and 24 months after study recruitment compared with baseline
Secondary outcome [5] 335881 0
Change in serum creatinine, measured by using whole blood sample collected in plain tube.
Timepoint [5] 335881 0
Measured at baseline, 3 months, 6 months, 12 months and 24 months after study recruitment compared with baseline
Secondary outcome [6] 335882 0
Change in blood pressure, measured by professional digital blood pressure monitor.
Timepoint [6] 335882 0
Measured at baseline, 3 months, 6 months, 12 months and 24 months after study recruitment compared with baseline
Secondary outcome [7] 336077 0
Change in nutritional intake from baseline, measured through 2 days food diary for control and 2 days food log via the application for the experimental group.
Timepoint [7] 336077 0
Taken at baseline, 3 months, and 6 months after study recruitment.

Eligibility
Key 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
Minimum age
21 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by sealed opaque envelopes. Equal number of "I" for intervention and "C" for control printed on folded paper will be prepared and placed in the envelopes. All these will be prepared by a third party not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation will be used in this study, with factors like gender (male and female), age (21 to 49 years old and 50 to 75 years old), Body Mass Index (< 27.5 kg/m2 and >/= 27.5 kg/m2) within the pre-diabetes and diabetes arm, effected by sealed envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be performed using SPSS for Windows version 21.0 (SPSS Inc, Chicago, IL, USA). Descriptive statistics for normally distributed numerical variables will be presented as mean (standard deviation) otherwise median (interquartile range) will be presented. Categorical data will be expressed as frequencies and percentages. Parametric tests (and the appropriate non-parametric) will be used to compare numerical variables between the control and intervention groups upon normality & homogeneity assumptions checking. For categorical variables, the chi-square or Fisher Exact tests will be used. Between-group differences in the primary outcomes, changes in HbA1c, Fasting Blood Glucose, Body Weight, Blood Lipids, Creatinine levels, Blood Pressure, nutrients intake (calorie, carbohydrate, sugar and other nutrient intake) will be investigated using the analysis of covariance (ANCOVA) adjusted for baseline measurements and relevant covariates. Statistical significance is set at p < 0.05.

In the qualitative study, data analysis will be done through a process of thematic analysis of the survey forms. For the cost effectiveness analysis, we will first compare the average costs of each treatment arm. Secondly, we will compare the average costs and outcomes across treatment arms relative to the control over both the immediate and long-term horizon. We will compute the within-study incremental cost-effectiveness ratio in terms of incremental cost per 1% drop in HbA1c and per kilogram weight loss. We will also estimate the incremental cost per percentage point reduction in lifetime diabetes risk and cost per QALY, using standard modeling techniques. Bootstrap techniques will be used to generate an empirical sampling distribution for the ICER and 95% bias-adjusted confidence intervals, as well as cost effectiveness acceptability curves, which show the probability that treatment is cost-effective at different threshold cost-effectiveness ratios (bearing in mind Singapore-specific thresholds consistent with WHO CHOICE benchmarks are at the time of writing approximately $60-75000 per QALY). With respect to the projected long-term benefits, sensitivity analysis will be performed to explore the robustness of our results to baseline assumptions.

In the quantitative study, regression models will be used to test for significant treatment effects after controlling for confounders.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8982 0
Singapore
State/province [1] 8982 0

Funding & Sponsors
Funding source category [1] 296692 0
Government body
Name [1] 296692 0
National Medical Research Council Health Services Research Grant
Address [1] 296692 0
Harbourfront Centre #09-66
1 Maritime Square (Lobby C)
Singapore 099253
Country [1] 296692 0
Singapore
Primary sponsor type
Individual
Name
Lim Su Lin
Address
National University Hospital
Dietetics Department
5 Lower Kent Ridge Road, Main Building
Level 1, Singapore 119074
Country
Singapore
Secondary sponsor category [1] 295652 0
Individual
Name [1] 295652 0
Khoo Chin Meng
Address [1] 295652 0
National University Hospital
5 Lower Kent Ridge Road,
Singapore 119074
Country [1] 295652 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297920 0
National Healthcare Group Domain Specific Review Board Domain D
Ethics committee address [1] 297920 0
Domain Specific Review Board (DSRB)
c/o National Healthcare Group, Research & Development Office (RDO)
Nexus @ One-North (South Tower)
No 3 Fusionopolis Link #03-08
Singapore 138543
Ethics committee country [1] 297920 0
Singapore
Date submitted for ethics approval [1] 297920 0
30/04/2017
Approval date [1] 297920 0
14/09/2017
Ethics approval number [1] 297920 0
2017/00397

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75462 0
Dr Lim Su Lin
Address 75462 0
National University Hospital
Dietetics Department, Main Building Level 1
5 Lower Kent ridge road
Singapore 119074
Country 75462 0
Singapore
Phone 75462 0
+65 6772 4580
Fax 75462 0
+65 6779 1938
Email 75462 0
su_lin_lim@nuhs.edu.sg
Contact person for public queries
Name 75463 0
Ms Ong Kai Wen
Address 75463 0
National University Hospital
Dietetics Department, Main Building Level 1
5 Lower Kent ridge road
Singapore 119074
Country 75463 0
Singapore
Phone 75463 0
+65 6772 5166
Fax 75463 0
+65 6779 1938
Email 75463 0
kai_wen_ong@nuhs.edu.sg
Contact person for scientific queries
Name 75464 0
Dr Lim Su Lin
Address 75464 0
National University Hospital
Dietetics Department, Main Building Level 1
5 Lower Kent ridge road
Singapore 119074
Country 75464 0
Singapore
Phone 75464 0
+65 6772 4580
Fax 75464 0
+65 6779 1938
Email 75464 0
su_lin_lim@nuhs.edu.sg

No information has been provided regarding IPD availability
Summary results
No Results