Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000531718
Ethics application status
Approved
Date submitted
7/03/2022
Date registered
5/04/2022
Date last updated
8/05/2024
Date data sharing statement initially provided
5/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a remote digital NUDGE on chronic disease outcomes in individuals with type 2 diabetes
Scientific title
The effect of a remote digital NUDGE on chronic disease outcomes in individuals with type 2 diabetes
Secondary ID [1] 306242 0
None
Universal Trial Number (UTN)
Trial acronym
NUDGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 325043 0
Condition category
Condition code
Metabolic and Endocrine 322474 322474 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Digital nudging is a strategy derived from behavioural economics and refers to changing people’s behaviour toward a desirable outcome by making the desirable option the salient, easy or default option, but without telling people what to do. As individuals have their mobile phones in close vicinity during most parts of the day, nudge interventions can be pushed to the users through the phone at critical times – e.g.,: closer to snacking time periods in the evening, when users most want, or likely need, the support.

Over 2 week period, individuals will be daily (micro-) randomized to receive a nudge SMS or no message. Each participant acts as their own control. MRT involves randomly assigning an intervention option at each relevant decision point: a point in time when—based on theory, participant’s past behaviour, and the participant’s current context—a particular intervention component might be efficacious. MRT will occur daily for two-weeks to either a tailored nudge or no nudge. These nudges will delivered at a time that is nominated at screening as being the optimal time to receive it.

A brief snippet of the nudge will be delivered thorough MMS (for Android phones) and iMessage (for iPhone users) on nudge days. When clicked, the full message will be shown in the study App (Intui Research). Automatic read receipt and user feedback response is recorded when the app is opened and the full version of the nudge content is accessed. Nudge content includes information about the negative consequences of snacking after dinner and/or immediately actionable alternatives. Nudges will be delivered in the evening, at a time the participant indicates the behaviour typically occurs, and at a time that will suit them to receive the message. A nudge is a message or image that can be read in 15 seconds or less.
Intervention code [1] 322712 0
Lifestyle
Comparator / control treatment
Nothing will be delivered on non-nudge days.
Control group
Active

Outcomes
Primary outcome [1] 330260 0
Mean within individual differences in incremental area under the curve (iAUC) measured by continuous glucose monitoring (CGM)
Timepoint [1] 330260 0
90 minutes post-dinner till 4 am between nudging days and non-nudging days during the 2 week intervention period
Secondary outcome [1] 405486 0
Nudge-specific differences in glycaemic response (iAUC/hr) measured by continuous glucose monitors between the seven picto-graphic nudges
Timepoint [1] 405486 0
90 minutes post-dinner till 4 am between nudging days and non-nudging days overall 2 weeks intervention period
Secondary outcome [2] 405487 0
Nudge-specific differences in snacking behaviour (CGM peaks) measured by continuous glucose monitors between the seven picto-graphic nudges
Timepoint [2] 405487 0
90 minutes post-dinner till 4 am between nudging days and non-nudging days over the 2-week intervention.
Secondary outcome [3] 405488 0
Difference in the frequency of CGM peaks measured by continuous glucose monitors
Timepoint [3] 405488 0
from 90 minutes post-dinner until 4 am between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [4] 405489 0
Difference in the magnitude of CGM peaks measured by continuous glucose monitors
Timepoint [4] 405489 0
from 90 minutes post-dinner until 4 am between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [5] 405490 0
changes in glucose iAUC measured by continuous glucose monitors
Timepoint [5] 405490 0
between the baseline lead-in and intervention 2-week periods
Secondary outcome [6] 405491 0
changes in glucose peaks (number and magnitude) measured by continuous glucose monitors
Timepoint [6] 405491 0
between the baseline lead-in and intervention 2-week periods.
Secondary outcome [7] 406921 0
Mean responses to the four sub-scales and the overall engagement score of the Nudge User Engagement Scale Questionnaire based on the validated user engagement scale questionnaire
Timepoint [7] 406921 0
at the end of the 2 weeks intervention period
Secondary outcome [8] 408050 0
Difference in night-to-night mean apnoea and hypopnea index (AHI) measured by the under-mattress sleep sensor
Timepoint [8] 408050 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [9] 408051 0
Difference in night-to-night mean sleep duration measured by the under-mattress sleep sensor
Timepoint [9] 408051 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [10] 408052 0
Difference in night-to-night mean timing of sleep onset measured by the under-mattress sleep sensor
Timepoint [10] 408052 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [11] 408053 0
Difference in night-to-night mean waking times measured by the under-mattress sleep sensor
Timepoint [11] 408053 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [12] 408054 0
Difference in night-to-night mean sleep depth measured by the under-mattress sleep sensor
Timepoint [12] 408054 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [13] 408055 0
Difference in night-to-night mean heart rate measured by the under-mattress sleep sensor
Timepoint [13] 408055 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [14] 408056 0
Difference in night-to-night variation (N2NV) of apnoea and hypopnea index (AHI) measured by the under-mattress sleep sensor (calculated as the night-to-night standard deviation of AHI)
Timepoint [14] 408056 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [15] 408057 0
Difference in night-to-night variation (N2NV) of sleep duration measured by the under-mattress sleep sensor (calculated as the night-to-night standard deviation of sleep duration)
Timepoint [15] 408057 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [16] 408058 0
Difference in night-to-night variation (N2NV) of the timing of sleep onset measured by the under-mattress sleep sensor (calculated as the night-to-night standard deviation of the timing of sleep onset)
Timepoint [16] 408058 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [17] 408059 0
Difference in night-to-night variation (N2NV) of the waking times measured by the under-mattress sleep sensor (calculated as the night-to-night standard deviation of the waking times)
Timepoint [17] 408059 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [18] 408060 0
Difference in night-to-night variation (N2NV) of sleep depth measured by the under-mattress sleep sensor (calculated as the night-to-night standard deviation of sleep depth)
Timepoint [18] 408060 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [19] 408061 0
Difference in night-to-night variation (N2NV) of heart rate measured by the under-mattress sleep sensor (calculated as the night-to-night standard deviation of heart rate)
Timepoint [19] 408061 0
between nudging days and non-nudging days during the 2-week intervention period
Secondary outcome [20] 420499 0
Nightly apnoea and hypopnea index (AHI) measured by the under-mattress sleep sensor
Timepoint [20] 420499 0
during 2 weeks of the lead-in phase at baseline
Secondary outcome [21] 420500 0
Nightly sleep duration measured by the under-mattress sleep sensor
Timepoint [21] 420500 0
during 2 weeks of the lead-in phase at baseline
Secondary outcome [22] 420501 0
Nightly timing of sleep onset measured by the under-mattress sleep sensor
Timepoint [22] 420501 0
during 2 weeks of the lead-in phase at baseline
Secondary outcome [23] 420502 0
Nightly waking times measured by the under-mattress sleep sensor
Timepoint [23] 420502 0
during 2 weeks of the lead-in phase at baseline
Secondary outcome [24] 420503 0
Nightly sleep depth measured by the under-mattress sleep sensor
Timepoint [24] 420503 0
during 2 weeks of the lead-in phase at baseline
Secondary outcome [25] 420504 0
Nightly sleep depth measured by the under-mattress sleep sensor
Timepoint [25] 420504 0
during 2 weeks of the lead-in phase at baseline
Secondary outcome [26] 420505 0
Nightly heart rate measured by the under-mattress sleep sensor

Timepoint [26] 420505 0
during 2 weeks of the lead-in phase at baseline
Secondary outcome [27] 420506 0
Mean responses to the two Nudge Content Questionnaire items
Timepoint [27] 420506 0
at the end of the 2 weeks intervention period
Secondary outcome [28] 420507 0
The frequency of categories of responses to the open-ended item
Timepoint [28] 420507 0
at the end of the 2 weeks intervention period
Secondary outcome [29] 420508 0
Mean time between nudge being sent and time it is observed
Timepoint [29] 420508 0
during 2 weeks of the intervention phase
Secondary outcome [30] 420509 0
The difference between dinner time and the time of nudges is observed
Timepoint [30] 420509 0
during 2 weeks of the intervention phase
Secondary outcome [31] 420510 0
Daily glucose iAUC measured by continuous glucose monitors
Timepoint [31] 420510 0
during lead-in phase at baseline

Eligibility
Key inclusion criteria
Adults with type 2 diabetes.
• Managed with diet or a stable dose of oral antidiabetic medications for at least 3 months.
• Report habitual snacking after dinner most nights (3 or more per week)
• Resident in the greater Adelaide area
• In possession of and uses a smartphone
• Capacity to provide written informed consent and willingness to participate and adhere with the study protocol
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A personal history/diagnosis (self-reported) of:
• Type 1 diabetes
• Individuals with advanced diabetes complications (renal dialysis, above ankle amputation, registered partially blind)
• Major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, borderline personality disorder),
• Eating disorder or restrictive eating pattern
• Any gastrointestinal condition or medication causing vomiting or affecting absorption.
• Current, planned or recently completed (within 6 months) treatment for cancer (excluding non-melanoma skin cancer)
• Insomnia
• Significant liver, kidney, cardiovascular or any other medical conditions that would in the opinion of the study physician adversely affect participation in the study (e.g. renal dialysis, liver cirrhosis, cardiac failure limiting activities of daily living, degenerative neurological disorder)
• Any other condition deemed unstable by the study physician
• Habitual evening consumption of alcohol other than one standard drink with dinner

Currently taking the following medications:
• Use of insulin or sulfonylurea
• Glucocorticoids
• Antipsychotic medications
• Opioid medications unless combined with paracetamol in a single formulation and used occasionally on a PRN basis

Additional exclusion criteria include:
• Shift-workers
• Pregnant or currently breastfeeding
• Weight stable at least 2 weeks prior to the study participation
• Anyone unable to comprehend the study protocol or provide informed consent (i.e. due to English language or cognitive difficulties)
• Those who have not had a coronavirus disease (COVID-19) vaccination

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2022
Actual
9/05/2022
Date of last participant enrolment
Anticipated
6/04/2023
Actual
6/04/2023
Date of last data collection
Anticipated
30/04/2023
Actual
30/04/2023
Sample size
Target
90
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 310590 0
Government body
Name [1] 310590 0
Department for Health and Wellbeing
Country [1] 310590 0
Australia
Funding source category [2] 313591 0
Charities/Societies/Foundations
Name [2] 313591 0
Diabetes Australia Research Program
Country [2] 313591 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
South Australia Health and Medical Research Institue (SAHMRI),
North Terrace,
Adelaide,
SA
5000
Country
Australia
Secondary sponsor category [1] 311777 0
University
Name [1] 311777 0
Flinders University
Address [1] 311777 0
Sturt Rd, Bedford Park SA 5042
Country [1] 311777 0
Australia
Other collaborator category [1] 282141 0
Charities/Societies/Foundations
Name [1] 282141 0
Diabetes SA
Address [1] 282141 0
159 Sir Donald Bradman Dr, Hilton SA 5033
Country [1] 282141 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310194 0
The University of Adelaide Human Research Ethics Committee (HREC)
Ethics committee address [1] 310194 0
Ethics committee country [1] 310194 0
Australia
Date submitted for ethics approval [1] 310194 0
12/11/2021
Approval date [1] 310194 0
11/01/2022
Ethics approval number [1] 310194 0
H-2022-002

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116826 0
Prof Gary Wittert
Address 116826 0
Level 7, South Australia Health and Medical Research Institue (SAHMRI),
North Terrace,
Adelaide,
SA
5000
Country 116826 0
Australia
Phone 116826 0
+61 409 411 789
Fax 116826 0
Email 116826 0
[email protected]
Contact person for public queries
Name 116827 0
Lijun Zhao
Address 116827 0
Level 7, South Australia Health and Medical Research Institue (SAHMRI),
North Terrace,
Adelaide,
SA
5000
Country 116827 0
Australia
Phone 116827 0
+61 08 8128 4898
Fax 116827 0
Email 116827 0
[email protected]
Contact person for scientific queries
Name 116828 0
Gary Wittert
Address 116828 0
Level 7, South Australia Health and Medical Research Institue (SAHMRI),
North Terrace,
Adelaide,
SA
5000
Country 116828 0
Australia
Phone 116828 0
+61 409 411 789
Fax 116828 0
Email 116828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data included in the main outcome paper will be made available following the publication of that paper and other data after any post hoc analyses have been undertaken and published. A formal request with a proposal indicating research questions, hypothesis, analysis and publication plan.
When will data be available (start and end dates)?
Available after data has been published, with no end date
Available to whom?
Academic researchers providing a formal request with a proposal indicating research questions, hypothesis, analysis and publication plan.
Available for what types of analyses?
For the purpose of scientific research
How or where can data be obtained?
On the request via email to principal investigator Gary Wittert ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14828Ethical approval  [email protected] 383442-(Uploaded-27-01-2022-01-06-49)-Study-related document.pdf
18815Statistical analysis plan    383442-(Uploaded-05-04-2023-16-48-46)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA micro-randomized pilot study to examine the impact of just-in-time nudging on after-dinner snacking in adults with type 2 diabetes: A study protocol.2023https://dx.doi.org/10.1111/dom.15159
N.B. These documents automatically identified may not have been verified by the study sponsor.