StandUPTV: Reducing Sedentary Screen Time in Adults

Study Overview
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Brief Summary
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The goal of this study is to develop an optimized intervention for reducing leisure sedentary screen time (SST) in middle-aged adults with overweight or obesity. Investigators will use the multiphase optimization (MOST) framework to conduct a highly efficient full-factorial experimental study to simultaneously test the main effects for each of three intervention components (LOCKOUT, TEXT, EARN) and their interactions (e.g., TEXT+EARN; LOCKOUT+EARN+TEXT) over 16 weeks.

Detailed Description
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Primary Aim: To identify which component(s) from three components under consideration for inclusion in StandUPTV reduce SST by >60 min per day per day at 16 weeks. The three components tested will be: (a) LOCKOUT (no vs. yes); (b) TEXT (no vs. yes); and (c) EARN (no vs. yes). The investigators will use a highly efficient experimental strategy to detect effects of individual components as well as all two- and three-way interactions. The secondary aim of this study is to examine how reductions in SST displace time into other active behaviors, i.e., light-intensity physical activity (LPA), moderate-to vigorous physical activity (MVPA) and activity type (e.g., housework, walking, exercise behaviors). The investigators will use both device-based (activPAL3c) and self-report (ACT24) measures to understand whether SST displacement can increase active behaviors, particularly MVPA.

Official Title
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StandUPTV: Reducing Sedentary Screen Time in Adults

Conditions
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Sedentary Behavior, Screen Time, Physical Activity, Sleep

Intervention / Treatment
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* Behavioral: Device-based feedback, self-monitoring, and education: CORE
* Behavioral: Sedentary Screen Time lockout: LOCKOUT
* Behavioral: Context-based prompts: TEXT
* Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 23-64.90 years of age BMI≥25 kg/m2 3+ h/day of SST Insufficiently active Own an Apple or Android smartphone/tablet Access to internet at home or unlimited data plan Willing to download StandUPTV Able to read/understand English Willing to be randomized Exclusion Criteria: Current smoker (more than once per week) Major life event (e.g., move out of study area, pregnant) MVPA contraindicated Occupation requires media use or high amounts of physical activity Drug abuse, major illness and/or psychological disorder

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Investigators will use the multiphase optimization (MOST) framework to conduct a highly efficient full-factorial experimental study to simultaneously test the main effects for each of three intervention components (LOCKOUT, TEXT, EARN) and their interactions (e.g., TEXT+EARN; LOCKOUT+EARN+TEXT) over 16 weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CORE<br>Participants will receive a core intervention which will include a basic version of the StandUPTV app and a Fitbit watch to use throughout the 16-week intervention.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. | Behavioral: Device-based feedback, self-monitoring, and education: CORE<br>* 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.<br>|
| Experimental: CORE + text<br>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. | Behavioral: Device-based feedback, self-monitoring, and education: CORE<br>* 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.<br>Behavioral: Context-based prompts: TEXT<br>* 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).<br>|
| Experimental: CORE + Lockout<br>CORE components + Lockout component 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 from the StandUPTV app 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. Participants will be provided with a planning tool for planning SST on a daily basis in order to reach their over 50% reduction goal. | Behavioral: Device-based feedback, self-monitoring, and education: CORE<br>* 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.<br>Behavioral: Sedentary Screen Time lockout: LOCKOUT<br>* Sedentary Screen Time lockout: LOCKOUT 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. Participants will be prompted to plan for their screen time and provided modest allowances for exceeding their screen time in a given week.<br>|
| Active Comparator: CORE + Earn<br>CORE components + 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 from the StandUPTV app 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. Participants will be provided a planning tool for planning SST on a daily basis in order to reach their over 50% reduction goal. | Behavioral: Device-based feedback, self-monitoring, and education: CORE<br>* 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.<br>Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN<br>* 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.<br>|
| Active Comparator: CORE + Text + Earn<br>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. | Behavioral: Device-based feedback, self-monitoring, and education: CORE<br>* 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.<br>Behavioral: Context-based prompts: TEXT<br>* 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).<br>Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN<br>* 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.<br>|
| Active Comparator: CORE + Text + Lockout<br>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). | Behavioral: Device-based feedback, self-monitoring, and education: CORE<br>* 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.<br>Behavioral: Sedentary Screen Time lockout: LOCKOUT<br>* Sedentary Screen Time lockout: LOCKOUT 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. Participants will be prompted to plan for their screen time and provided modest allowances for exceeding their screen time in a given week.<br>Behavioral: Context-based prompts: TEXT<br>* 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).<br>|
| Active Comparator: CORE + Earn + Lockout<br>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. | Behavioral: Device-based feedback, self-monitoring, and education: CORE<br>* 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.<br>Behavioral: Sedentary Screen Time lockout: LOCKOUT<br>* Sedentary Screen Time lockout: LOCKOUT 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. Participants will be prompted to plan for their screen time and provided modest allowances for exceeding their screen time in a given week.<br>Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN<br>* 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.<br>|
| Active Comparator: CORE + Earn + Lockout + Text<br>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). | Behavioral: Device-based feedback, self-monitoring, and education: CORE<br>* 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.<br>Behavioral: Sedentary Screen Time lockout: LOCKOUT<br>* Sedentary Screen Time lockout: LOCKOUT 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. Participants will be prompted to plan for their screen time and provided modest allowances for exceeding their screen time in a given week.<br>Behavioral: Context-based prompts: TEXT<br>* 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).<br>Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Sedentary Screen Time | Minutes per week as measured by Stand UPTV app and activPAL | Baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in moderate to vigorous physical activity | Minutes per week as measured by activPAL | Baseline, 8 weeks, 16 weeks | 
| Changes in time spent sitting | Minutes per day as measured by activPAL | Baseline, 8 weeks, 16 weeks | 
| Changes in time spent standing | Minutes per day as measured by activPAL | Baseline, 8 weeks, 16 weeks | 
| Changes in time spent stepping | Minutes per day as measured by activPAL | Baseline, 8 weeks, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiphase optimization strategy, Mobile health