TY - JOUR
T1 - A micro-randomized pilot study to examine the impact of just-in-time nudging on after-dinner snacking in adults with type 2 diabetes
T2 - A study protocol
AU - Zhao, Lijun
AU - Bidargaddi, Niranjan
AU - Vakulin, Andrew
AU - Li, Wenhao
AU - Luscombe-Marsh, Natalie
AU - Benton, Fiona
AU - Adams, Robert
AU - Kemps, Eva
AU - Vincent, Andrew D.
AU - Heilbronn, Leonie K.
AU - Wittert, Gary A.
PY - 2023/9
Y1 - 2023/9
N2 - Aim: To determine whether a digital nudge soon after dinner reduces after-dinner snacking events as measured objectively by continuous glucose monitoring (CGM) in patients with type 2 diabetes (T2D). Methods: This is a single-site micro-randomized trial (MRT). People with T2D, aged 18-75 years, managed with diet or a stable dose of oral antidiabetic medications for at least 3 months, and who habitual snack after dinner at least 3 nights per week, will be recruited. Picto-graphic nudges were designed by mixed research methods. After a 2-week lead-in phase to determine eligibility and snacking behaviours by a CGM detection algorithm developed by the investigators, participants will be micro-randomized daily (1:1) to a second 2-week period to either a picto-graphic nudge delivered-in-time (Intui Research) or no nudge. During lead-in and MRT phases, 24-hour glucose will be measured by CGM, sleep will be tracked by an under-mattress sleep sensor, and dinner timing will be captured daily by photographing the evening meal. Results: The primary outcome is the difference in the incremental area under the CGM curve between nudging and non-nudging days during the period from 90 minutes after dinner until 04:00 AM. Secondary outcomes include the effect of baseline characteristics on treatment, and comparisons of glucose peaks and time-in-range between nudging and non-nudging days. The feasibility of 'just-in-time' messaging and nudge acceptability will be evaluated, along with the analysis of sleep quality measures and their night-to-night variability. Conclusions: This study will provide preliminary evidence of the impact of appropriately timed digital nudges on 24 -hour intertitial glucose levels resulting from altered after-dinner snacking in people with T2D. An exploratory sleep substudy will provide evidence of a bidirectional relationship between after-dinner snacking behaviour, glycaemia and sleep. Ultimately, this study will allow for the design of a future confirmatory study of the potential for digital nudging to improve health related behaviours and health outcomes.
AB - Aim: To determine whether a digital nudge soon after dinner reduces after-dinner snacking events as measured objectively by continuous glucose monitoring (CGM) in patients with type 2 diabetes (T2D). Methods: This is a single-site micro-randomized trial (MRT). People with T2D, aged 18-75 years, managed with diet or a stable dose of oral antidiabetic medications for at least 3 months, and who habitual snack after dinner at least 3 nights per week, will be recruited. Picto-graphic nudges were designed by mixed research methods. After a 2-week lead-in phase to determine eligibility and snacking behaviours by a CGM detection algorithm developed by the investigators, participants will be micro-randomized daily (1:1) to a second 2-week period to either a picto-graphic nudge delivered-in-time (Intui Research) or no nudge. During lead-in and MRT phases, 24-hour glucose will be measured by CGM, sleep will be tracked by an under-mattress sleep sensor, and dinner timing will be captured daily by photographing the evening meal. Results: The primary outcome is the difference in the incremental area under the CGM curve between nudging and non-nudging days during the period from 90 minutes after dinner until 04:00 AM. Secondary outcomes include the effect of baseline characteristics on treatment, and comparisons of glucose peaks and time-in-range between nudging and non-nudging days. The feasibility of 'just-in-time' messaging and nudge acceptability will be evaluated, along with the analysis of sleep quality measures and their night-to-night variability. Conclusions: This study will provide preliminary evidence of the impact of appropriately timed digital nudges on 24 -hour intertitial glucose levels resulting from altered after-dinner snacking in people with T2D. An exploratory sleep substudy will provide evidence of a bidirectional relationship between after-dinner snacking behaviour, glycaemia and sleep. Ultimately, this study will allow for the design of a future confirmatory study of the potential for digital nudging to improve health related behaviours and health outcomes.
KW - continuous glucose monitoring
KW - dietary behaviour
KW - evening snacking
KW - mHealth
KW - nudging
KW - sleep
KW - type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85164129136&partnerID=8YFLogxK
U2 - 10.1111/dom.15159
DO - 10.1111/dom.15159
M3 - Article
C2 - 37385960
AN - SCOPUS:85164129136
SN - 1462-8902
VL - 25
SP - 2439
EP - 2446
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
IS - 9
ER -
