Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
NCT ID:
NCT04464993
Description:
None
Frequency Threshold:
0
Time Frame:
Baseline to 16 weeks (end of intervention period).
Study:
NCT04464993
Study Brief:
StandUPTV: Reducing Sedentary Screen Time in Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CORE | Participants will receive a "core" intervention which will include a basic version of the StandUPTV app and a Fitbit watch.The Fitbit will provide device-based behavioral feedback through the StandUPTV self-monitoring component. SST feedback will be Self-monitoring will provide passive and objective feedback regarding SST behaviors and MVPA drawn from Fitbit and SCREENTIME sources. StandUPTV will also contain basic education including information on the risks of SST and tips for reducing SST. As part of this education, all participants will be provided a behavioral target of reducing their SST by 50% from their baseline. This target will be customized for the participant within StandUPTV based on a baseline week of observation. Device-based feedback, self-monitoring, and education: CORE: Participants will receive a "core" intervention which will include a basic version of the StandUPTV app on an android tablet and a Fitbit to use throughout the 16-week intervention.t. SST feedback will be provided within the smartphone application. Self-monitoring will provide passive and objective feedback regarding SST behaviors. StandUPTV will also contain basic education including information on the risks of SST and tips for reducing SST. As part of this education, all participants will be provided a behavioral target of reducing their SST by 50% from their baseline. This target will be customized for the participant within StandUPTV based on a baseline week of observation. | 0 | None | 0 | 11 | 0 | 11 | View |
| CORE + Text | CORE components + The TEXT component uses app-based prompts (i.e., prompts generated through StandUPTV app) that will provide simple adaptive content based upon length of most recent SST bout and time of day. These prompts will specifically target outcome expectations around SST and MVPA. Device-based feedback, self-monitoring, and education: CORE: Participants will receive a "core" intervention which will include a basic version of the StandUPTV app on an android tablet and a Fitbit to use throughout the 16-week intervention.t. SST feedback will be provided within the smartphone application. Self-monitoring will provide passive and objective feedback regarding SST behaviors. StandUPTV will also contain basic education including information on the risks of SST and tips for reducing SST. As part of this education, all participants will be provided a behavioral target of reducing their SST by 50% from their baseline. This target will be customized for the participant within StandUPTV based on a baseline week of observation. Context-based prompts: TEXT: The TEXT component uses app-based prompts (i.e., prompts generated through StandUPTV, not text message based) that will provide simple adaptive content. Content of the prompts will be educational (i.e., based on risks of sedentary screen time) and motivational (i.e., advice to reduce sedentary screen time). | 0 | None | 0 | 13 | 0 | 13 | View |
| CORE + Earn | CORE components + 50% per week reduction in SST, based upon a baseline week. If SST reaches the prescribed threshold, the investigators will use the limits from the StandUPTV app to restrict screen time through the end of the week (Monday-Sunday). Participants will be provided a planning tool for planning SST on a daily basis in order to reach their over 50% reduction goal. Device-based feedback, self-monitoring, and education: CORE: Participants will receive a basic version of the StandUPTV app on an android tablet and a Fitbit to use throughout the 16-week intervention. SST feedback will be provided within the smartphone application. Self-monitoring will provide passive and objective feedback regarding SST behaviors. StandUPTV will also contain basic education including information on the risks of SST and tips for reducing SST. All participants will be provided a behavioral target of reducing their SST by 50% from their baseline. EARN: Earn sedentary screen time through moderate-vigorous physical activity: EARN Participants assigned to the EARN component will earn SST by engaging in a \>5 min continuous bout of exercise (as defined by Fitbit minutes \>4 metabolic equivalents). They will earn SST on a 3:1 ratio up until they reach their baseline level of MVPA (5 mins of exercise earns 15 mins of SST). They will receive behavioral strategies to reduce screen time within the app (e.g., self-efficacy, barriers, exercising safely) and a planning tool for scheduling MVPA. | 0 | None | 0 | 16 | 0 | 16 | View |
| CORE + Text + Earn | Intervention components will be delivered as described in simpler factorial conditions. App shows progress toward SST goal or if goal is exceeded. Can earn additional SST through exercise based on 3:1 ratio , simple adaptive content (by SST bout, time of day). Lockout component will enforce a 50% per week reduction in SST, based upon a baseline week of observation. | 0 | None | 0 | 15 | 0 | 15 | View |
| CORE + Text + Lockout | Intervention components will be delivered as described in simpler factorial conditions, and... If exceeded, the limits feature will restrict screen time through the end of the week (Monday-Sunday) so cannot exceed limit. Simple adaptive content (by SST bout, time of day). | 0 | None | 0 | 15 | 0 | 15 | View |
| CORE + Earn + Lockout | Intervention components will be delivered as described in simpler factorial conditions, and... If exceeded, the limits feature will restrict screen time through the end of the week (Monday-Sunday) so cannot exceed limit. Can earn additional SST through exercise based on 3:1 ratio. | 0 | None | 0 | 10 | 0 | 10 | View |
| CORE + Earn + Lockout + Text | Intervention components will be delivered as described in simpler factorial conditions, and... If exceeded, the limits feature will restrict screen time through the end of the week (Monday-Sunday) so cannot exceed limit. Can earn additional SST through exercise based on 3:1 ratio). Simple adaptive content (by SST bout, time of day). | 0 | None | 0 | 16 | 0 | 16 | View |
| CORE + Lockout | CORE components + Lockout component will enforce a 50% per week reduction in SST, based upon a baseline week. If SST reaches the prescribed threshold, the StandUPTV app will restrict screen time through the end of the week (Monday-Sunday). Participants will be provided with a planning tool for planning SST. Device-based feedback, self-monitoring, and education: CORE: Participants will receive a "core" intervention which will include a basic version of the StandUPTV app on an android tablet and a Fitbit to use. SST feedback will be provided within the smartphone application. Self-monitoring will provide passive and objective feedback regarding SST behaviors. StandUPTV will also contain basic education including information on the risks of SST and tips for reducing SST. As part of this education, all participants will be provided a behavioral target of reducing their SST by 50% from their baseline. This target will be customized for the participant within StandUPTV based on a baseline week of observation. Sedentary Screen Time lockout: LOCKOUT The investigators will enforce a 50% per week reduction in SST, based upon a baseline week of observation. If SST reaches the prescribed threshold, the investigators will use the limits feature to restrict screen time through the end of the week (Monday-Sunday); at which point, 50% baseline allotment will be reinstated for an additional week. | 0 | None | 0 | 14 | 0 | 14 | View |
Serious Events(If Any):
Other Events(If Any):