An interventional study of Nudge in Overweight and Obesity, Overweight and Obesity, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
The purpose of this pilot study is to examine the effects of different types of just-in-time intervention messages on daily meeting dietary, activity, and weighing goals in a sample of young adults participating in a mobile-based weight loss program.
Public health interventions typically rely on a set schedule of intervention delivery. Advances in technology and computer tailoring allow us to go from a "one size fits all" approach to one that uses digital health data to deliver "just-in-time adaptive interventions," or JITAIs, that can vary the timing, dose, and content of intervention messages to individuals. This pilot study is a micro-randomized trial that evaluates the effects of various intervention message options delivered in JIT moments on meeting dietary, activity, and weighing goals among young adults in a mobile-based weight loss program.
The Nudge study is a 12-week mobile health weight loss program delivered via a native smartphone application. Individuals are asked to track their red foods (high-calorie, high-fat foods) in the app daily and meet their personalized red foods goal, wear a Fitbit daily and meet their daily active minutes goal, and weigh daily on their WiFi-enabled scale. Up to 4 times each day, participants are randomized to receive or not receive intervention messages in order to examine the effects of these intervention message types on meeting daily weighing goals, red food goals, and activity goals. This is a within-subjects design in which each participant serves as their own control, and data is analyzed at the person-day level.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 53 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each of 7 intervention message options has specific decision rules (including weighed/not weighed and progress toward daily dietary and activity goals) that make a participant eligible to receive a specific intervention type at a specific time (decision points). At each decision point (early morning, morning, midday, and evening), the system evaluates which intervention options a participant is eligible to receive, and randomly chooses one intervention option from that list. Then the participant is randomly assigned to either receive or not receive that intervention message (with a 50-50 probability).
Behavioral: Nudge
Nudge is a smartphone-app-based micro-randomized trial that tests the effect of 7 intervention message types based on behavior change techniques on daily goal attainment. Participants have three daily goals: weigh daily, red foods goal, and active minutes goal.
Percent of person-days with same-day weighing
Percent who weighed after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
Time frame: from Baseline to Week 12
Percent of person-days with next-day weighing
Percent who weighed the day after the message randomization (at the participant-day level) across the 12-week study
Time frame: from Baseline to Week 12
Percent of person-days met active minutes goal on same day
Percent who met active minutes goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
Time frame: from Baseline to Week 12
Percent of person-days met active minutes goal on next day
Percent who met active minutes goal the day after the message randomization (at the participant-day level) across the 12-week study
Time frame: from Baseline to Week 12
Percent of person-days met red foods goal on same day
Percent who met red foods goal after the message randomization time until the end of the day (at the participant-day level) across the 12-week study
Time frame: from Baseline to Week 12
Percent of person-days met red foods goal on next day
Percent who met red foods goal the day after the message randomization (at the participant-day level) across the 12-week study
Time frame: from Baseline to Week 12
Number of active minutes
Total number of active minutes on the day of message randomization (at the participant-day level) across the 12-week study
Time frame: from Baseline to Week 12
Proximal effect of message on total red foods today
Total number of red foods on the day of message randomization (at the participant-day level) across the 12-week study
Time frame: from Baseline to Week 12
Mean weight change
Mean weight change across participants
Time frame: from Baseline to Week 12
Plan to share: No
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill