Sedentary LifestyleNCT03417440
A Smartphone App to Improve Physical Activity
A study testing Physical Activity (PA) Tracker App, On Your Feet and Coach Me in people with Sedentary Lifestyle, run by University of Southern California at 2 sites in United States.
Trial summary
The purpose of this study is to develop, test, and optimize a physical activity (PA)-tracking smartphone app and specialty features, which are designed to facilitate older adults' PA by targeting common barriers in this population. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Physical Activity (PA) Tracker App, On Your Feet and Coach Me
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Apr 2018to 12 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-84 years old
- English speaking
- reside in Los Angeles
- score ≥5 on a 6-item cognitive screener
- report <150 minutes of moderate to vigorous PA/week as per a single-item screener
- ambulatory
Show all 9Show fewer
- able to safely participate in physical activity as determined by the Revised Physical Activity Readiness Questionnaire (rPARQ) or proof of medical clearance from a physician
- smartphone owner for ≥3 months
- observed ability to reliably access and operate a smartphone during orientation.
Who cannot join
- ≥85 years old, based on limited smartphone ownership and to reduce sample variability
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Front Porch Center for Innovation and Wellbeing
Glendale, California, 91203
University of Southern California
Los Angeles, California, 90089-9003
About this study
Official title: A Smartphone Application to Improve Physical Activity in Underactive Older Adults
The purpose of this study is to develop, test, and optimize a physical activity (PA)-tracking smartphone app and specialty features, which are designed to facilitate older adults' PA by targeting common barriers in this population. For example, one feature sends messages throughout the day about the good things about growing older to combat negative views about aging which has been linked to decreased PA. Participants will include older adult smartphone users who are between the ages of 65 and 84 and are not very physically active. In phase one of the study, three groups of five older adults will be formed to test the PA-tracking app and one of three specialty features for a two-week period, followed by a focus group to learn about the older adults' experiences. In phase two, approximately 100 participants will be randomly assigned to one of eight groups that include various combinations of specialty features with the PA tracker, for the purpose of pilot testing the app for a four-month period. Testing will occur at the beginning and the end of the four-month intervention period, and will measure PA levels, sedentary activity time, self-reported PA, and functional mobility.
Read the detailed description
In this study, we will optimize a set of tailored specialty app features designed to be paired with a physical activity (PA)-tracking app to boost older adults' PA. This package, termed the MovingUp suite, is distinct from generic fitness apps because it blends a set of specialized components that reflect empirically supported constructs from social cognitive and stereotype embodiment theory with evidence-based behavior change techniques (e.g., self-regulation) foundational to basic activity monitoring. Specialty features include: (a) explicit and implicit messaging to promote positive aging views; (b) sedentary activity monitoring with motivational messaging and peer suggestions; and (c) tailored messaging to increase the intensity level of everyday activities and overcome barriers. We will utilize a highly efficient, innovative methodological approach-Multiphase Optimization Strategy (MOST)-to provide an experimental context for evaluating the viability of each MovingUp specialty feature.
Aim 1: Assess the feasibility and acceptability of the three MovingUp specialty features. We will first examine MovingUp's feasibility and acceptability in three groups of five older adults (aged 65-84 years). A basic PA-tracking app plus one of three specialty features will be introduced-a different feature per group-at an orientation session. Groups will then test their assigned specialty feature with the PA tracker for two weeks. This step will involve real-time user data collection, check-ins via phone, and follow-up focus groups. Feasibility and acceptability will be determined by analyzing participants' usage patterns, evaluations of MovingUp features (based on a health technology usability scale and focus group interviews), and self-reported facilitators and barriers to successful app use. Our team will review the data and integrate changes as needed, producing an upgraded prototype to be assessed in Aim 2.
Aim 2: Conduct a pilot test to examine performance characteristics and PA-relevant outcomes of MovingUp's specialty features. Aim 2 includes the MOST Screening Phase: theory-guided experimentation to identify viable components within a multifaceted preliminary intervention plan. Using a factorial design as specified in MOST procedures, 100 underactive older adults (i.e., accumulating <150 minutes of moderate intensity activity per week) will be randomly assigned to one of eight conditions which reflect all possible combinations of presence vs. absence of the three respective specialty features, given usage of a PA tracker app. At the end of a four-month intervention period, for each specialty feature we will examine changes from baseline in PA-related outcomes including: objective PA (primary outcome), sedentary activity time, self-reported PA, and functional mobility. We will also examine the app components' relationships to theoretically postulated mediating constructs (self-efficacy, self-regulation, outcome expectation, social support, aging self-perception, and views of aging). In addition, we will document usage rate, sustained usage, and perceived usefulness for achieving PA goals for each suite component.
Aim 3: Synthesize information from Aim 2 to design an optimized MovingUp suite to be evaluated in a future RCT. Our study team will interpret and synthesize the array of resulting data to derive an optimized MovingUp suite. A set of pre-specified criteria will be used to guide selection of components in the optimized app. Using preliminary efficacy data, the stage will be set for a fully powered RCT of MovingUp's beneficial effects in comparison to alternate technologies such as web-based or mHealth solutions.
This project will help establish a methodological foundation for future attempts to enhance PA apps via the addition of theoretically based component features. Moreover, it will provide insights into the theoretical underpinnings of successful PA interventions for older adults, leading to information that transcends any single technology-based solution.
- Conditions
- Sedentary Lifestyle
- Being tested
- Physical Activity (PA) Tracker App, On Your Feet, Coach Me, Proof Positive
- Keywords
- smartphone app, physical activity, older adults
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity (PA) Tracker AppOther
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
On Your FeetOther
On Your Feet is a specialty app feature designed to be paired with a PA tracker app and reduce sedentary activity-a health risk factor largely independent of insufficient PA. This feature utilizes self-regulatory and behavior change techniques including goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent at a user-specified frequency; and general tips and previously compiled, older adult-identified strategies to reduce sedentary activity are texted. Additionally, messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach MeOther
Coach Me is a specialty app feature designed to be paired with a PA tracker app and includes daily messages that assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Blending PA with productive activity facilitates PA engagement in older adults. In Coach Me, suggestions on how to intensify daily activities are tailored based on user selections from an activity inventory. This app feature helps older adults become more active in a minimally intrusive way, while allowing for engagement in productive and meaningful activities. Coach Me asks users to select obstacles to PA encountered in the previous week. Based on those selections, the app sends strategies on how to overcome those barriers, thereby targeting self-efficacy.
Proof PositiveOther
Proof Positive is a specialty app feature designed to be paired with a PA tracker app and capitalizes on the beneficial effects that exposure to positive aging messages and stereotypes has on health and PA. When activated, users (a) receive texts describing how old age does not equate to physical inability, (b) obtain information about the benefits of growing older, and (c) are presented with a weekly positive aging stereotype task modeled after a computerized series. This last function exposes users to blocks of "positive priming words." Primers are quickly flashed to allow perception without awareness while users focus on a simple icon that represents PA. Icons are intended to provide an additional PA cue, maintain user interest, and increase the external validity.
| Study group | Role | What they receive |
|---|---|---|
| PA App+ On Your Feet+ CoachMe+ Proof Pos | Other | Participants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following 3 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (3) "Proof Positive" (explicit and implicit messaging to promote positive aging views). Receives: Other: Physical Activity (PA) Tracker App; Other: On Your Feet; Other: Coach Me; Other: Proof Positive |
| PA App + On Your Feet + Coach Me | Other | Participants in this arm will use a basic physical activity (PA) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers). Receives: Other: Physical Activity (PA) Tracker App; Other: On Your Feet; Other: Coach Me |
| PA App + On Your Feet + Proof Positive | Other | Participants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views). Receives: Other: Physical Activity (PA) Tracker App; Other: On Your Feet; Other: Proof Positive |
| PA App + On Your Feet | Other | Participants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following feature: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions). Receives: Other: Physical Activity (PA) Tracker App; Other: On Your Feet |
| PA App + Coach Me + Proof Positive | Other | Participants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following 2 features: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views). Receives: Other: Physical Activity (PA) Tracker App; Other: Coach Me; Other: Proof Positive |
| PA App + Coach Me | Other | Participants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following feature: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers). Receives: Other: Physical Activity (PA) Tracker App; Other: Coach Me |
| PA App + Proof Positive | Other | Participants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following feature: (1) "Proof Positive" (explicit and implicit messaging to promote positive aging views). Receives: Other: Physical Activity (PA) Tracker App; Other: Proof Positive |
| PA App | Other | Participants in this arm will use a basic physical activity (PA) tracker app without any additional features. Receives: Other: Physical Activity (PA) Tracker App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions
Step counts (objective physical activity) were measured using the activPAL thigh-worn accelerometer during a 72-hour monitoring period.
Estimated average change is computed as the change in activPAL-tracked mean daily steps at Month 4 relative to baseline; this outcome is analyzed in a linear regression analysis model. All randomized participants who started the intervention and had valid activity monitor data were utilized in the model (ITT analysis)
Measured: 72-hour monitoring periods at Month 4 relative to baseline
Secondary outcomes (13)
Daily Sitting Time (activPAL) Change From Baseline to Month 4
Objective sedentary activity time was measured using the activPAL thigh-worn accelerometer during a 72-hour monitoring period. Expressed as average minutes/day.
Measured: 72-hour monitoring periods at Month 4 relative to baseline
Self-reported Physical Activity (PASE) Change From Baseline to Month 4
Self-reported physical activity will be measured via the Physical Activity Scale for the Elderly (PASE). PASE is a ten-item instrument designed to assess engagement in physical activities commonly pursued by older adults, including those related to leisure, household, and occupational tasks. The tool is a valid and reliable measure of physical activity engagement in the older adult population. Scores range from 0 to 361. Higher scores indicate a higher level of activity.
Measured: baseline and 4 months
Gait Speed (4-m Walk Test) Change From Baseline to Month 4
Functional mobility will be assessed through a four-meter walk test, a commonly used, validated measure of physical and functional performance in older adults.
Measured: baseline and 4 months
Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline
The potential mediators of physical activity self-efficacy, self-regulation, outcome expectation, and social support will each be measured separately using subscales of the 78-item physical activity portion of the Health Beliefs Survey. Subscales demonstrate sufficient internal consistencies (Cronbach's α=0.68-0.90) and are predictive of physical activity. Higher scores indicate greater self-efficacy. Possible scores for the self-efficacy subscale range from 0-100.
Measured: baseline and 4 months
Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
The potential mediators of physical activity self-efficacy, self-regulation, outcome expectation, and social support will each be measured separately using subscales of the 78-item physical activity portion of the Health Beliefs Survey. Subscales demonstrate sufficient internal consistencies (Cronbach's α=0.68-0.90) and are predictive of physical activity. Higher scores indicate greater self-regulation behaviors. Possible scores for the self-regulation subscale range from 1-5.
Measured: baseline and 4 months
Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
The potential mediators of physical activity self-efficacy, self-regulation, outcome expectation, and social support will each be measured separately using subscales of the 78-item physical activity portion of the Health Beliefs Survey. Subscales demonstrate sufficient internal consistencies (Cronbach's α=0.68-0.90) and are predictive of physical activity. Higher scores indicate greater family social support for physical activity. Possible scores for the family social support subscale range from 1 - 5.
Measured: baseline and 4 months
Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
The potential mediators of physical activity self-efficacy, self-regulation, outcome expectation, and social support will each be measured separately using subscales of the 78-item physical activity portion of the Health Beliefs Survey. Subscales demonstrate sufficient internal consistencies (Cronbach's α=0.68-0.90) and are predictive of physical activity. Higher scores indicate greater outcome expectations. Possible scores for the outcome expectation subscale range from 1-25
Measured: baseline and 4 months
Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline
Aging self-perceptions will be assessed by the Attitudes Toward Own Aging subscale of the Philadelphia Geriatrics Center Morale Scale. This five-question tool captures the subjective aging experience, shows moderate internal consistency (Cronbach's α=0.61-0.64), and predicts mortality risk. Scores can range from 0 to 5. A higher score indicates more positive aging self-perceptions.
Measured: baseline and 4 months
Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline
Views of aging will be measured using the Attitudes to Ageing Questionnaire. This 24-item assessment identifies subjective views about age-related changes in multiple domains, is cross-culturally valid, and is psychometrically sound (Cronbach's α=0.68-0.84). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score for psychosocial loss indicates more negative attitude (min 8; max 40).
Measured: baseline and 4 months
Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline
Views of aging will be measured using the Attitudes to Ageing Questionnaire. This 24-item assessment identifies subjective views about age-related changes in multiple domains, is cross-culturally valid, and is psychometrically sound (Cronbach's α=0.68-0.84). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score on physical change indicates more positive attitude (min 8; max 40)
Measured: baseline and 4 months
Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline
Views of aging will be measured using the Attitudes to Ageing Questionnaire. This 24-item assessment identifies subjective views about age-related changes in multiple domains, is cross-culturally valid, and is psychometrically sound (Cronbach's α=0.68-0.84). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score on psychological growth indicates more positive attitude (min 8; max 40).
Measured: baseline and 4 months
App Usage Behavior
Usage behavior is defined as the proportion of days the app was opened across the 4-month trial period
Measured: from baseline through Month 4 (daily)
Perceived App Quality (uMARS)
The Mobile App Rating Scale User Version (uMARS) was used to measure user satisfaction with the app, particularly participant's ratings for app quality. The uMARS includes a usability feedback subindex which is comprised of the average of item responses for 4 subsections (engagement, functionality, aesthetics, information), to yield a total quality score. Ratings are on a scale of 1 (low perceived quality, min) to 5 (high perceived quality, max).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start23 Apr 2018
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Multiphase Optimization Strategy (MOST) is a recent methodology for optimizing multi-component interventions prior to performing more comprehensive testing in large RCTs. The Most Framework includes 5 steps: (1) Establish theoretical model; (2) Identify individual intervention components; (3) Conduct experiment to examine individual components; (4) Assemble beta intervention package; and (5) Confirm efficacy of optimized intervention. To our knowledge, only two prior studies have used MOST to refine a complex app with physical activity elements and disentangle the relative efficacy of specific features within a larger suite.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of California, Los Angeles
- Responsible party
- Principal investigator, Stacey L. Schepens Niemiec, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417440
- Sponsor's protocol ID
- HS-16-00670
- Other IDs
- R21AG052838
- Status last verified
- Oct 2022
- First submitted
- 24 Jan 2018
- Last updated
- 21 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This proposal does not involve a multisite trial. The University of Southern California is the only project site. Funds greater than $500,000 are not requested and thus data-sharing is not required. The final results and dataset of the project, however, will be published and shared according to the NIH regulations in order to improve the transparency of the research.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Application to Improve Physical Activity in Underactive Older Adults
- ClinicalTrials.gov ID
- NCT03417440
- Acronym / sponsor ID
- HS-16-00670
- Conditions
- Sedentary Lifestyle
- Keywords
- smartphone app, physical activity, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of California, Los Angeles
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Posted 21 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop, test, and optimize a physical activity (PA)-tracking smartphone app and specialty features, which are designed to facilitate older adults' PA by targeting common barriers in this population. For example, one feature sends messages throughout the day about the good things about growing older to combat negative views about aging which has been linked to decreased PA. Participants will include older adult smartphone users who are between the ages of 65 and 84 and are not very physically active. In phase one of the study, three groups of five older adults will be formed to test the PA-tracking app and one of three specialty features for a two-week period, followed by a focus group to learn about the older adults' experiences. In phase two, approximately 100 participants will be randomly assigned to one of eight groups that include various combinations of specialty features with the PA tracker, for the purpose of pilot testing the app for a four-month period. Testing will occur at the beginning and the end of the four-month intervention period, and will measure PA levels, sedentary activity time, self-reported PA, and functional mobility.
Detailed description
In this study, we will optimize a set of tailored specialty app features designed to be paired with a physical activity (PA)-tracking app to boost older adults' PA. This package, termed the MovingUp suite, is distinct from generic fitness apps because it blends a set of specialized components that reflect empirically supported constructs from social cognitive and stereotype embodiment theory with evidence-based behavior change techniques (e.g., self-regulation) foundational to basic activity monitoring. Specialty features include: (a) explicit and implicit messaging to promote positive aging views; (b) sedentary activity monitoring with motivational messaging and peer suggestions; and (c) tailored messaging to increase the intensity level of everyday activities and overcome barriers. We will utilize a highly efficient, innovative methodological approach-Multiphase Optimization Strategy (MOST)-to provide an experimental context for evaluating the viability of each MovingUp specialty feature.
Aim 1: Assess the feasibility and acceptability of the three MovingUp specialty features. We will first examine MovingUp's feasibility and acceptability in three groups of five older adults (aged 65-84 years). A basic PA-tracking app plus one of three specialty features will be introduced-a different feature per group-at an orientation session. Groups will then test their assigned specialty feature with the PA tracker for two weeks. This step will involve real-time user data collection, check-ins via phone, and follow-up focus groups. Feasibility and acceptability will be determined by analyzing participants' usage patterns, evaluations of MovingUp features (based on a health technology usability scale and focus group interviews), and self-reported facilitators and barriers to successful app use. Our team will review the data and integrate changes as needed, producing an upgraded prototype to be assessed in Aim 2.
Aim 2: Conduct a pilot test to examine performance characteristics and PA-relevant outcomes of MovingUp's specialty features. Aim 2 includes the MOST Screening Phase: theory-guided experimentation to identify viable components within a multifaceted preliminary intervention plan. Using a factorial design as specified in MOST procedures, 100 underactive older adults (i.e., accumulating <150 minutes of moderate intensity activity per week) will be randomly assigned to one of eight conditions which reflect all possible combinations of presence vs. absence of the three respective specialty features, given usage of a PA tracker app. At the end of a four-month intervention period, for each specialty feature we will examine changes from baseline in PA-related outcomes including: objective PA (primary outcome), sedentary activity time, self-reported PA, and functional mobility. We will also examine the app components' relationships to theoretically postulated mediating constructs (self-efficacy, self-regulation, outcome expectation, social support, aging self-perception, and views of aging). In addition, we will document usage rate, sustained usage, and perceived usefulness for achieving PA goals for each suite component.
Aim 3: Synthesize information from Aim 2 to design an optimized MovingUp suite to be evaluated in a future RCT. Our study team will interpret and synthesize the array of resulting data to derive an optimized MovingUp suite. A set of pre-specified criteria will be used to guide selection of components in the optimized app. Using preliminary efficacy data, the stage will be set for a fully powered RCT of MovingUp's beneficial effects in comparison to alternate technologies such as web-based or mHealth solutions.
This project will help establish a methodological foundation for future attempts to enhance PA apps via the addition of theoretically based component features. Moreover, it will provide insights into the theoretical underpinnings of successful PA interventions for older adults, leading to information that transcends any single technology-based solution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Multiphase Optimization Strategy (MOST) is a recent methodology for optimizing multi-component interventions prior to performing more comprehensive testing in large RCTs. The Most Framework includes 5 steps: (1) Establish theoretical model; (2) Identify individual intervention components; (3) Conduct experiment to examine individual components; (4) Assemble beta intervention package; and (5) Confirm efficacy of optimized intervention. To our knowledge, only two prior studies have used MOST to refine a complex app with physical activity elements and disentangle the relative efficacy of specific features within a larger suite.
| Arm | Type | Receives |
|---|---|---|
| PA App+ On Your Feet+ CoachMe+ Proof Pos | Other | Other: Physical Activity (PA) Tracker App, Other: On Your Feet, Other: Coach Me, Other: Proof PositiveParticipants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following 3 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (3) "Proof Positive" (explicit and implicit messaging to promote positive aging views). |
| PA App + On Your Feet + Coach Me | Other | Other: Physical Activity (PA) Tracker App, Other: On Your Feet, Other: Coach MeParticipants in this arm will use a basic physical activity (PA) app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers). |
| PA App + On Your Feet + Proof Positive | Other | Other: Physical Activity (PA) Tracker App, Other: On Your Feet, Other: Proof PositiveParticipants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following 2 features: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views). |
| PA App + On Your Feet | Other | Other: Physical Activity (PA) Tracker App, Other: On Your FeetParticipants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following feature: (1) "On Your Feet" (sedentary activity monitoring with motivational messaging and peer suggestions). |
| PA App + Coach Me + Proof Positive | Other | Other: Physical Activity (PA) Tracker App, Other: Coach Me, Other: Proof PositiveParticipants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following 2 features: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers); and (2) "Proof Positive" (explicit and implicit messaging to promote positive aging views). |
| PA App + Coach Me | Other | Other: Physical Activity (PA) Tracker App, Other: Coach MeParticipants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following feature: (1) "Coach Me" (tailored messaging to increase the intensity level of everyday activities and overcome barriers). |
| PA App + Proof Positive | Other | Other: Physical Activity (PA) Tracker App, Other: Proof PositiveParticipants in this arm will use a basic physical activity (PA) tracker app in conjunction with the following feature: (1) "Proof Positive" (explicit and implicit messaging to promote positive aging views). |
| PA App | Other | Other: Physical Activity (PA) Tracker AppParticipants in this arm will use a basic physical activity (PA) tracker app without any additional features. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 65-84 years old
- English speaking
- reside in Los Angeles
- score ≥5 on a 6-item cognitive screener
- report <150 minutes of moderate to vigorous PA/week as per a single-item screener
Key exclusion criteria (1 listed)
- ≥85 years old, based on limited smartphone ownership and to reduce sample variability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity (PA) Tracker AppThis PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation. | Other | PA App, PA App + Coach Me, PA App + Coach Me + Proof Positive, PA App + On Your Feet, PA App + On Your Feet + Coach Me, PA App + On Your Feet + Proof Positive, PA App + Proof Positive, PA App+ On Your Feet+ CoachMe+ Proof Pos |
| On Your FeetOn Your Feet is a specialty app feature designed to be paired with a PA tracker app and reduce sedentary activity-a health risk factor largely independent of insufficient PA. This feature utilizes self-regulatory and behavior change techniques including goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent at a user-specified frequency; and general tips and previously compiled, older adult-identified strategies to reduce sedentary activity are texted. Additionally, messages about the benefits of reducing sedentary activity and overcoming barriers are sent. | Other | PA App + On Your Feet, PA App + On Your Feet + Coach Me, PA App + On Your Feet + Proof Positive, PA App+ On Your Feet+ CoachMe+ Proof Pos |
| Coach MeCoach Me is a specialty app feature designed to be paired with a PA tracker app and includes daily messages that assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Blending PA with productive activity facilitates PA engagement in older adults. In Coach Me, suggestions on how to intensify daily activities are tailored based on user selections from an activity inventory. This app feature helps older adults become more active in a minimally intrusive way, while allowing for engagement in productive and meaningful activities. Coach Me asks users to select obstacles to PA encountered in the previous week. Based on those selections, the app sends strategies on how to overcome those barriers, thereby targeting self-efficacy. | Other | PA App + Coach Me, PA App + Coach Me + Proof Positive, PA App + On Your Feet + Coach Me, PA App+ On Your Feet+ CoachMe+ Proof Pos |
| Proof PositiveProof Positive is a specialty app feature designed to be paired with a PA tracker app and capitalizes on the beneficial effects that exposure to positive aging messages and stereotypes has on health and PA. When activated, users (a) receive texts describing how old age does not equate to physical inability, (b) obtain information about the benefits of growing older, and (c) are presented with a weekly positive aging stereotype task modeled after a computerized series. This last function exposes users to blocks of "positive priming words." Primers are quickly flashed to allow perception without awareness while users focus on a simple icon that represents PA. Icons are intended to provide an additional PA cue, maintain user interest, and increase the external validity. | Other | PA App + Coach Me + Proof Positive, PA App + On Your Feet + Proof Positive, PA App + Proof Positive, PA App+ On Your Feet+ CoachMe+ Proof Pos |
Primary outcome
Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions
Time frame: 72-hour monitoring periods at Month 4 relative to baseline
Step counts (objective physical activity) were measured using the activPAL thigh-worn accelerometer during a 72-hour monitoring period. Estimated average change is computed as the change in activPAL-tracked mean daily steps at Month 4 relative to baseline; this outcome is analyzed in a linear regression analysis model. All randomized participants who started the intervention and had valid activity monitor data were utilized in the model (ITT analysis)
13 secondary outcomes
Daily Sitting Time (activPAL) Change From Baseline to Month 4
Time frame: 72-hour monitoring periods at Month 4 relative to baseline
Self-reported Physical Activity (PASE) Change From Baseline to Month 4
Time frame: baseline and 4 months
Gait Speed (4-m Walk Test) Change From Baseline to Month 4
Time frame: baseline and 4 months
Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline
Time frame: baseline and 4 months
Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
Time frame: baseline and 4 months
Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
Time frame: baseline and 4 months
Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline
Time frame: baseline and 4 months
Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline
Time frame: baseline and 4 months
Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline
Time frame: baseline and 4 months
Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline
Time frame: baseline and 4 months
Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline
Time frame: baseline and 4 months
App Usage Behavior
Time frame: from baseline through Month 4 (daily)
Perceived App Quality (uMARS)
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. This proposal does not involve a multisite trial. The University of Southern California is the only project site. Funds greater than $500,000 are not requested and thus data-sharing is not required. The final results and dataset of the project, however, will be published and shared according to the NIH regulations in order to improve the transparency of the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity (PA) Tracker App, On Your Feet and Coach Me in people with Sedentary Lifestyle, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions (time frame: 72-hour monitoring periods at Month 4 relative to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.