None listed
Conditions
Brief summary
This study will examine the efficacy of delivering an electronic just in time nudge to reduce glucose levels at home in individuals with type 2 diabetes. Delivering an pictographic behavioural nudge by smartphone app (Intui Research) with a SMS reminder proximal to the anticipated time of snacking, compared to non-nudge delivery, will lead to a reduction in the glucose area under the curve after dinner measured by continuous glucose monitors and improved sleep health.
Interventions
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
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.
Sponsors
The University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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
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
Outcome results
None listed