StandUPTV: Reducing Sedentary Screen Time in Adults

Sponsor
Arizona State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04464993
Collaborator
California Polytechnic State University-San Luis Obispo (Other)
240
2
8
22.3
120
5.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention 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.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 (Outcomes Assessor)
Masking Description:
Outcomes assessor will not have access to study arm assignment and participants will be encouraged not to divulge their study arm assignment during assessments.
Primary Purpose:
Prevention
Official Title:
StandUPTV: Reducing Sedentary Screen Time in Adults
Actual Study Start Date :
Jun 21, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CORE

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
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.

Experimental: 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.

Behavioral: 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.

Behavioral: 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).

Experimental: CORE + Lockout

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
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.

Behavioral: Sedentary Screen Time lockout: LOCKOUT
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.

Active Comparator: CORE + Earn

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
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.

Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: 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.

Active Comparator: 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.

Behavioral: 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.

Behavioral: 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).

Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: 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.

Active Comparator: 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).

Behavioral: 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.

Behavioral: Sedentary Screen Time lockout: LOCKOUT
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.

Behavioral: 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).

Active Comparator: 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.

Behavioral: 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.

Behavioral: Sedentary Screen Time lockout: LOCKOUT
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.

Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: 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.

Active Comparator: 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).

Behavioral: 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.

Behavioral: Sedentary Screen Time lockout: LOCKOUT
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.

Behavioral: 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).

Behavioral: Earn sedentary screen time through moderate-vigorous physical activity: 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.

Outcome Measures

Primary Outcome Measures

  1. Changes in Sedentary Screen Time [Baseline to 16 weeks]

    Minutes per week as measured by Stand UPTV app and activPAL

Secondary Outcome Measures

  1. Changes in moderate to vigorous physical activity [Baseline, 8 weeks, 16 weeks]

    Minutes per week as measured by activPAL

  2. Changes in time spent sitting [Baseline, 8 weeks, 16 weeks]

    Minutes per day as measured by activPAL

  3. Changes in time spent standing [Baseline, 8 weeks, 16 weeks]

    Minutes per day as measured by activPAL

  4. Changes in time spent stepping [Baseline, 8 weeks, 16 weeks]

    Minutes per day as measured by activPAL

Eligibility Criteria

Criteria

Ages Eligible for Study:
23 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona State University Tempe Arizona United States 85281
2 California Polytechnic University San Luis Obispo San Luis Obispo California United States 93407

Sponsors and Collaborators

  • Arizona State University
  • California Polytechnic State University-San Luis Obispo

Investigators

  • Principal Investigator: Matthew P Buman, PhD, Arizona State University
  • Principal Investigator: Sarah Keadle, PhD, California Polytechnic University - San Luis Obispo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arizona State University
ClinicalTrials.gov Identifier:
NCT04464993
Other Study ID Numbers:
  • R01CA239612
First Posted:
Jul 9, 2020
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Arizona State University

Study Results

No Results Posted as of Feb 25, 2022