NCT04464993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 15, 2025

Completed
Last Updated

April 15, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

July 3, 2020

Results QC Date

February 21, 2025

Last Update Submit

April 11, 2025

Conditions

Keywords

Multiphase optimization strategyMobile health

Outcome Measures

Primary Outcomes (1)

  • Changes in Sedentary Screen Time

    Minutes per day as measured by Stand UPTV app and activPAL

    Baseline to 16 weeks

Secondary Outcomes (4)

  • Changes in Moderate to Vigorous Physical Activity

    Baseline to16 weeks

  • Changes in Time Spent Sitting

    Baseline to 16 weeks

  • Changes in Time Spent Standing

    Baseline and 16 weeks

  • Changes in Time Spent Stepping

    Baseline to 16 weeks

Study Arms (8)

CORE

EXPERIMENTAL

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

CORE + text

EXPERIMENTAL

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: COREBehavioral: Context-based prompts: TEXT

CORE + Lockout

EXPERIMENTAL

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: COREBehavioral: Sedentary Screen Time lockout: LOCKOUT

CORE + Earn

ACTIVE COMPARATOR

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: COREBehavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN

CORE + Text + Earn

ACTIVE COMPARATOR

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: COREBehavioral: Context-based prompts: TEXTBehavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN

CORE + Text + Lockout

ACTIVE COMPARATOR

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: COREBehavioral: Sedentary Screen Time lockout: LOCKOUTBehavioral: Context-based prompts: TEXT

CORE + Earn + Lockout

ACTIVE COMPARATOR

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: COREBehavioral: Sedentary Screen Time lockout: LOCKOUTBehavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN

CORE + Earn + Lockout + Text

ACTIVE COMPARATOR

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: COREBehavioral: Sedentary Screen Time lockout: LOCKOUTBehavioral: Context-based prompts: TEXTBehavioral: Earn sedentary screen time through moderate-vigorous physical activity: EARN

Interventions

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.

CORECORE + EarnCORE + Earn + LockoutCORE + Earn + Lockout + TextCORE + LockoutCORE + Text + EarnCORE + Text + LockoutCORE + text

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.

CORE + Earn + LockoutCORE + Earn + Lockout + TextCORE + LockoutCORE + Text + Lockout

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).

CORE + Earn + Lockout + TextCORE + Text + EarnCORE + Text + LockoutCORE + text

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.

CORE + EarnCORE + Earn + LockoutCORE + Earn + Lockout + TextCORE + Text + Earn

Eligibility Criteria

Age23 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • BMI≥25 kg/m2
  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arizona State University

Tempe, Arizona, 85281, United States

Location

California Polytechnic University San Luis Obispo

San Luis Obispo, California, 93407, United States

Location

Related Publications (3)

  • Hasanaj K, Leonard KS, Sears DD, Yu F, Petrov ME, Keadle SK, Buman MP. Bidirectional associations of recreational sedentary screen time and 24-h behaviors: a dynamic cross-sectional multilevel model analysis. J Act Sedentary Sleep Behav. 2026 Feb 1. doi: 10.1186/s44167-026-00096-0. Online ahead of print.

  • Keadle SK, Hasanaj K, Leonard KS, Fernandez A, Freid L, Weiss S, Legato M, Anand H, Hagobian TA, Phillips SM, Phelan S, Guastaferro K, Seltzer RGN, Buman MP. StandUPTV: a full-factorial optimization trial to reduce sedentary screen time among adults. Int J Behav Nutr Phys Act. 2025 Jun 13;22(1):77. doi: 10.1186/s12966-025-01771-2.

  • Keadle S, Hasanaj K, Leonard-Corzo KS, Fernandez A, Freid L, Weiss S, Legato M, Anand H, Hagobian T, Phillips S, Phelan S, Guastaferro K, Seltzer R, Buman M. StandUPTV: A full-factorial optimization trial to reduce sedentary screen time among adults. Res Sq [Preprint]. 2025 Feb 24:rs.3.rs-5984168. doi: 10.21203/rs.3.rs-5984168/v1.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Owing to delays in initiating and slowing recruitment during the COVID-19 pandemic, we did not meet the enrollment targets. Trial concluded when funding ended.

Results Point of Contact

Title
Matthew P Buman, PhD, Director & Professor
Organization
Arizona State University

Study Officials

  • Matthew P Buman, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR
  • Sarah Keadle, PhD

    California Polytechnic University - San Luis Obispo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will not have access to study arm assignment and participants will be encouraged not to divulge their study arm assignment during assessments.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 9, 2020

Study Start

June 21, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

April 15, 2025

Results First Posted

April 15, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations