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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04464993
Other study ID # R01CA239612
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2021
Est. completion date September 30, 2023

Study information

Verified date December 2023
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 177
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 23 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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).
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.

Locations

Country Name City State
United States California Polytechnic University San Luis Obispo San Luis Obispo California
United States Arizona State University Tempe Arizona

Sponsors (2)

Lead Sponsor Collaborator
Arizona State University California Polytechnic State University-San Luis Obispo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Sedentary Screen Time Minutes per week as measured by Stand UPTV app and activPAL Baseline to 16 weeks
Secondary Changes in moderate to vigorous physical activity Minutes per week as measured by activPAL Baseline, 8 weeks, 16 weeks
Secondary Changes in time spent sitting Minutes per day as measured by activPAL Baseline, 8 weeks, 16 weeks
Secondary Changes in time spent standing Minutes per day as measured by activPAL Baseline, 8 weeks, 16 weeks
Secondary Changes in time spent stepping Minutes per day as measured by activPAL Baseline, 8 weeks, 16 weeks
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