Physical Activity, Screen Time, Sedentary Behavior, Sleep
Conditions
Keywords
Multiphase optimization strategy, Mobile health
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.
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.
Interventions
BEHAVIORALDevice-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.
BEHAVIORALSedentary 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.
BEHAVIORALContext-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).
BEHAVIORALEarn 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.
Sponsors
California Polytechnic State University-San Luis Obispo
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
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.
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.
Eligibility
Sex/Gender
ALL
Age
23 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Sedentary Screen Time | Baseline to 16 weeks | Minutes per day as measured by Stand UPTV app and activPAL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Moderate to Vigorous Physical Activity | Baseline to16 weeks | Changes in moderate to vigorous physical activity (minutes per day as measured by activPAL) |
| Changes in Time Spent Sitting | Baseline to 16 weeks | Changes in time spent sitting (Minutes per day as measured by activPAL) |
| Changes in Time Spent Standing | Baseline and 16 weeks | Changes in minutes per day of standing time as measured by activPAL |
| Changes in Time Spent Stepping | Baseline to 16 weeks | Minutes per day as measured by activPAL |
Countries
United States
Participant flow
Recruitment details
Data collection was scheduled to begin in July 2020 but was delayed until June 21, 2021 because of COVID-19. Specifically, we removed planned cardiovascular biomarker assessment, and the protocol was modified to conduct all assessments virtually, which opened recruitment to those outside the Phoenix, AZ and San Luis Obispo areas but delayed the start of the study. Enrollment continued until April 2023, and data collection was completed in September 2023.
Pre-assignment details
The participants were required to have ≥4 days of measured screen time (i.e., verification from the study server that tablet and WeMo data were transmitted \> 10 h/day) during the baseline period and were asked to repeat the baseline test if they had \< 4 days recorded.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 13 |
| 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. | 14 |
| 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. | 16 |
| 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. | 15 |
| 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). | 15 |
| 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. | 10 |
| 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). | 16 |
| Total | 110 |
Baseline characteristics
| Characteristic | CORE | CORE + Text | CORE + Lockout | CORE + Earn | CORE + Text + Earn | CORE + Text + Lockout | CORE + Earn + Lockout | CORE + Earn + Lockout + Text | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 10.6 | 45.5 years STANDARD_DEVIATION 12.7 | 47.0 years STANDARD_DEVIATION 10.5 | 42.9 years STANDARD_DEVIATION 12.7 | 40.8 years STANDARD_DEVIATION 12.2 | 42.7 years STANDARD_DEVIATION 10.9 | 41.5 years STANDARD_DEVIATION 12.7 | 42.0 years STANDARD_DEVIATION 11.7 | 42.0 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 8 Participants | 11 Participants | 13 Participants | 13 Participants | 12 Participants | 8 Participants | 13 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 00 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 14 Participants |
| Race/Ethnicity, Customized Race Black | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Unknown | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 9 Participants | 11 Participants | 13 Participants | 12 Participants | 9 Participants | 10 Participants | 7 Participants | 11 Participants | 82 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 12 Participants | 13 Participants | 10 Participants | 12 Participants | 8 Participants | 14 Participants | 90 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 3 Participants | 2 Participants | 2 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 13 | 0 / 14 | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 16 |
| other Total, other adverse events | 0 / 11 | 0 / 13 | 0 / 14 | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 16 |
| serious Total, serious adverse events | 0 / 11 | 0 / 13 | 0 / 14 | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 10 | 0 / 16 |
Outcome results
Primary
Changes in Sedentary Screen Time
Minutes per day as measured by Stand UPTV app and activPAL
Time frame: Baseline to 16 weeks
Population: Analyzed sample with multiple imputation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CORE | Changes in Sedentary Screen Time | -88.2 minutes per day |
| CORE + Text | Changes in Sedentary Screen Time | -60.1 minutes per day |
| CORE + Lockout | Changes in Sedentary Screen Time | -102.7 minutes per day |
| CORE + Earn | Changes in Sedentary Screen Time | -118.1 minutes per day |
| CORE + Text + Earn | Changes in Sedentary Screen Time | -17.0 minutes per day |
| CORE + Text + Lockout | Changes in Sedentary Screen Time | -72.8 minutes per day |
| CORE + Earn + Lockout | Changes in Sedentary Screen Time | -94.3 minutes per day |
| CORE + Earn + Lockout + Text | Changes in Sedentary Screen Time | -125.7 minutes per day |
Secondary
Changes in Moderate to Vigorous Physical Activity
Changes in moderate to vigorous physical activity (minutes per day as measured by activPAL)
Time frame: Baseline to16 weeks
Population: Analyzed sample with multiple imputation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CORE | Changes in Moderate to Vigorous Physical Activity | -7.2 minutes per day |
| CORE + Text | Changes in Moderate to Vigorous Physical Activity | -0.1 minutes per day |
| CORE + Lockout | Changes in Moderate to Vigorous Physical Activity | 1.0 minutes per day |
| CORE + Earn | Changes in Moderate to Vigorous Physical Activity | -0.7 minutes per day |
| CORE + Text + Earn | Changes in Moderate to Vigorous Physical Activity | 1.2 minutes per day |
| CORE + Text + Lockout | Changes in Moderate to Vigorous Physical Activity | -15.6 minutes per day |
| CORE + Earn + Lockout | Changes in Moderate to Vigorous Physical Activity | 1.5 minutes per day |
| CORE + Earn + Lockout + Text | Changes in Moderate to Vigorous Physical Activity | 0.3 minutes per day |
Secondary
Changes in Time Spent Sitting
Changes in time spent sitting (Minutes per day as measured by activPAL)
Time frame: Baseline to 16 weeks
Population: Analyzed sample with multiple imputation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CORE | Changes in Time Spent Sitting | -29.7 minutes per day |
| CORE + Text | Changes in Time Spent Sitting | -38.6 minutes per day |
| CORE + Lockout | Changes in Time Spent Sitting | 27.9 minutes per day |
| CORE + Earn | Changes in Time Spent Sitting | -8.2 minutes per day |
| CORE + Text + Earn | Changes in Time Spent Sitting | -14.9 minutes per day |
| CORE + Text + Lockout | Changes in Time Spent Sitting | 1.5 minutes per day |
| CORE + Earn + Lockout | Changes in Time Spent Sitting | 56.4 minutes per day |
| CORE + Earn + Lockout + Text | Changes in Time Spent Sitting | 2.1 minutes per day |
Secondary
Changes in Time Spent Standing
Changes in minutes per day of standing time as measured by activPAL
Time frame: Baseline and 16 weeks
Population: Analyzed sample with imputation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CORE | Changes in Time Spent Standing | -0.4 minutes per day |
| CORE + Text | Changes in Time Spent Standing | 27.4 minutes per day |
| CORE + Lockout | Changes in Time Spent Standing | -15.7 minutes per day |
| CORE + Earn | Changes in Time Spent Standing | -8.7 minutes per day |
| CORE + Text + Earn | Changes in Time Spent Standing | 10.3 minutes per day |
| CORE + Text + Lockout | Changes in Time Spent Standing | -2.8 minutes per day |
| CORE + Earn + Lockout | Changes in Time Spent Standing | -37.7 minutes per day |
| CORE + Earn + Lockout + Text | Changes in Time Spent Standing | 7.0 minutes per day |
Secondary
Changes in Time Spent Stepping
Minutes per day as measured by activPAL
Time frame: Baseline to 16 weeks
Population: Analyzed sample with imputation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CORE | Changes in Time Spent Stepping | 0.9 minutes per day |
| CORE + Text | Changes in Time Spent Stepping | 3.3 minutes per day |
| CORE + Lockout | Changes in Time Spent Stepping | -0.2 minutes per day |
| CORE + Earn | Changes in Time Spent Stepping | -3.1 minutes per day |
| CORE + Text + Earn | Changes in Time Spent Stepping | 5.9 minutes per day |
| CORE + Text + Lockout | Changes in Time Spent Stepping | -12.0 minutes per day |
| CORE + Earn + Lockout | Changes in Time Spent Stepping | -4.3 minutes per day |
| CORE + Earn + Lockout + Text | Changes in Time Spent Stepping | 4.4 minutes per day |