Individuals in this study are enrolled in a large health research program called the All of Us Research Program (AoURP). Eligible individuals receive an invitation email for the WEAR sub-study. To enroll, they need to complete a separate consent module, agree that they are willing to receive text messages as part of study and confirm that they understand that they are supposed to wear their Fitbit device for at least one year. After completing these steps, individuals set up a Fitbit account (or log in to an existing one) and provide authorization to share their Fitbit data with AoURP. They are then taken to a dedicated Fitbit store when they can order a Fitbit free of charge. At study launch the two models are on offer were the latest versions of Fitbit's smartwatch (Versa 3) and the slim wristband (Charge 4), though we may upgrade to newer models as they are released by Fitbit. The Fitbit order is processed and delivered by Fitbit and the device will automatically start sharing data with the research program the moment that it is set up by the individual (following the usual set-up instructions provided by Fitbit).
Once individuals start using their device, they will start a 3-6 week onboarding period during which they receive support messages via text once a week (Sunday). The length of the onboarding period differs depending on when the individual starts using their device. We want to ensure that each participant receives a minimum of 3 support messages. If they start using their device when there are fewer than 3 Sundays remaining in that calendar month, their onboarding period will be extended to cover the next month as well. During the onboarding period, individuals receive information about their wear target, that wearing their device is important for health research, how they need to sync their device, information about the study support center and feedback on how they have performed relative to their target. This onboarding period is important to ensure that all participants are informed about the purpose of the study and what is expected of them. In addition, it gives participants in the message choice condition familiarity with the reminder messages so that they can make a more informed choice when they are prompted about their communication frequency choice.
At the end of the onboarding period, individuals receive a support message informing them that they have 11 more months remaining in the study. Depending on the support message frequency condition they have been assigned, they are informed that they will receive no more support messages for the remaining 11 months (standard Fitbit message condition), will continue to receive support messages once a week (default AoURP message frequency condition) or are prompted to declare their preferred cadence of support messages (participant choice message frequency condition). All participants are informed that they can change their study notification preferences via the research portal, but only the choice group can set their preferences by responding to the text message prompt. This group will receive a prompt to confirm or modify their chosen cadence at the 6-month mark.