- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04464993
StandUPTV: Reducing Sedentary Screen Time in Adults (StandUPTV)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthew P Buman, PhD
- Phone Number: (602) 496-8617
- Email: matthew.buman@asu.edu
Study Contact Backup
- Name: Arlene Fernandez
- Phone Number: (602) 543-3756
- Email: Arlene.D.R.Fernandez@asu.edu
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85281
- Arizona State University
-
-
California
-
San Luis Obispo, California, United States, 93407
- California Polytechnic University San Luis Obispo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
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.
|
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.
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.
|
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.
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. |
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.
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).
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). |
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.
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).
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 + 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. |
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.
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.
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). |
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.
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).
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Sedentary Screen Time
Time Frame: Baseline to 16 weeks
|
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
Time Frame: Baseline, 8 weeks, 16 weeks
|
Minutes per week as measured by activPAL
|
Baseline, 8 weeks, 16 weeks
|
Changes in time spent sitting
Time Frame: Baseline, 8 weeks, 16 weeks
|
Minutes per day as measured by activPAL
|
Baseline, 8 weeks, 16 weeks
|
Changes in time spent standing
Time Frame: Baseline, 8 weeks, 16 weeks
|
Minutes per day as measured by activPAL
|
Baseline, 8 weeks, 16 weeks
|
Changes in time spent stepping
Time Frame: Baseline, 8 weeks, 16 weeks
|
Minutes per day as measured by activPAL
|
Baseline, 8 weeks, 16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew P Buman, PhD, Arizona State University
- Principal Investigator: Sarah Keadle, PhD, California Polytechnic University - San Luis Obispo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01CA239612 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruiting
Clinical Trials on Device-based feedback, self-monitoring, and education: CORE
-
The Miriam HospitalCompletedObesityUnited States
-
University of Alabama at BirminghamNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruitingType 2 Diabetes
-
University of BirminghamEuropean Commission; Dudley NHS Foundation TrustCompletedOsteoarthritis | Physical Activity | Sedentary Lifestyle | Orthopedic Disorder | Arthropathy of Knee | Arthropathy of HipUnited Kingdom
-
Second Affiliated Hospital, School of Medicine,...Shaoxing Gaobu Street Community Health Service Center; Shaoxing Mashan Street... and other collaboratorsCompletedStroke | Cognitive Impairment | DementiaChina
-
University of TennesseeNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompletedObesity | OverweightUnited States
-
The University of Texas Health Science Center at...The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)Recruiting
-
Kyungpook National University HospitalMinistry of Trade, Industry & Energy, Republic of Korea; Korea Evaluation Institute... and other collaboratorsCompletedKidney TransplantationKorea, Republic of
-
University of North Carolina, Chapel HillCompletedObesity | Cardiovascular Disease | CancerUnited States
-
Sutter HealthGE Healthcare; University of California, Davis; LifeScanCompletedDiabetes Mellitus, Type 2United States
-
Akdeniz UniversityUnknownPeritoneal Dialysis | Self Efficacy | Perceived Social Support | Self-CareTurkey