Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001112358
Ethics application status
Approved
Date submitted
10/07/2017
Date registered
28/07/2017
Date last updated
23/02/2023
Date data sharing statement initially provided
22/04/2020
Date results provided
28/10/2021
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.
Secondary outcome [8] 402454 0
Physical activity (minutes per week) were collected using self-reported questionnaire
Timepoint [8] 402454 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [9] 402455 0
Diabetes medication type and dosages were collected at baseline and during outcome visits via survey questions. The diabetes medication costs were derived from the Pharmaceutical Society of Singapore Database and the private rates charged by the National University Hospital, Singapore.
Timepoint [9] 402455 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [10] 402456 0
Questionnaire on participants' experience in using mobile apps, The questionnaire was made prior to the commencement of enrolment.
Timepoint [10] 402456 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [11] 402457 0
Questionnaire on participants' self-assessment of previous diet advice, dietary patterns and dietary habits. The questionnaire was made prior to the commencement of enrolment.

Timepoint [11] 402457 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [12] 402458 0
Questionnaire on participants' self-assessment of health status, The questionnaire was made prior to the commencement of enrolment.
Timepoint [12] 402458 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [13] 402459 0
Questionnaire on participants' self assessment of her/his stage of change using the validated Transtheoretical Model of Change, The questionnaire was made prior to the commencement of enrolment.
Timepoint [13] 402459 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [14] 402460 0
Composite questionnaire on participants' incurred healthcare costs. The questionnaire was made prior to the commencement of enrolment.
Timepoint [14] 402460 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [15] 402461 0
Questionnaire on participants' self- assessment of factors leading to weight outcomes, The questionnaire was made prior to the commencement of enrolment.
Timepoint [15] 402461 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [16] 402462 0
Questionnaire on participants' confidence in achieving weight loss and making lifestyle changes. The questionnaire was made prior to the commencement of enrolment.
Timepoint [16] 402462 0
The questionnaire was conducted at baseline, and at 3-month, 6-month, 12-month and 24-month after study recruitment.
Secondary outcome [17] 402463 0
App utilization and engagement data on participants randomised to the intervention group. These data are generated by the developer and the app’s backend dashboard .
Timepoint [17] 402463 0
The data were retrieved at 3-months and 6-month 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
Sex
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
Continuous variables will be presented as means with standard deviations, and categorical variables as frequencies and percentages. Parametric tests will be used where normality and homogeneity assumptions are satisfied, otherwise Mann-Whitney U tests will be performed. Generalized linear mixed model analysis will be performed on the change from baseline for each numerical outcome to account for clustering effect of recruitment sources as random effect. For participants with Diabetes, subgroup analysis on participants with suboptimal baseline HbA1c levels (ie,>8%) will be performed on changes in HbA1c and fasting blood glucose. Comparison of changes from baseline between control and intervention groups will be performed using a paired t test. Type I error for multiple comparisons was adjusted using the Benjamini-Hochberg procedure with false discovery rate at 0.20. Generalized Poisson mixed-model analysis will be performed for changes in medication dosages of subgroup taking diabetes medications, to derive the relative risks.
Statistical significance will be set at 2-sided P < .05. Between-group Cohen d effect sizes will be calculated. Multiple imputation methods will be used to derive missing data points, with 5 imputations performed for each missing value using the Markov chain Monte Carlo method with predictive mean matching for the primary outcome, secondary outcomes, randomization group, and demographic characteristics. Results from 5 imputed data sets will be combined.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/08/2017
Actual
3/10/2017
Date of last participant enrolment
Anticipated
30/04/2020
Actual
20/09/2019
Date of last data collection
Anticipated
20/09/2022
Actual
20/09/2022
Sample size
Target
380
Accrual to date
Final
352
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
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
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
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
[email protected]
Contact person for public queries
Name 75463 0
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
[email protected]
Contact person for scientific queries
Name 75464 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.