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A Smartphone App to Improve Physical Activity

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ClinicalTrials.gov Identifier: NCT03417440
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
University of California, Los Angeles
Information provided by (Responsible Party):
Stacey Lynn Schepens Niemiec, University of Southern California

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Other: Physical Activity (PA) Tracker App Other: On Your Feet Other: Coach Me Other: Proof Positive Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Study measures (apart from accelerometry, Health-ITUES, and usage data-see below) will be administered by a condition-blind tester at a study site at baseline and post-intervention.
Primary Purpose: Other
Official Title: A Smartphone Application to Improve Physical Activity in Underactive Older Adults
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
PA App+ On Your Feet+ CoachMe+ Proof Pos
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).
Other: Physical Activity (PA) Tracker App
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.

Other: On Your Feet
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.

Other: Coach Me
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.

Other: Proof Positive
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.

PA App + On Your Feet + Coach Me
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).
Other: Physical Activity (PA) Tracker App
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.

Other: On Your Feet
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.

Other: Coach Me
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.

PA App + On Your Feet + Proof Positive
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).
Other: Physical Activity (PA) Tracker App
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.

Other: On Your Feet
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.

Other: Proof Positive
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.

PA App + On Your Feet
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).
Other: Physical Activity (PA) Tracker App
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.

Other: On Your Feet
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.

PA App + Coach Me + Proof Positive
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).
Other: Physical Activity (PA) Tracker App
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.

Other: Coach Me
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.

Other: Proof Positive
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.

PA App + Coach Me
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).
Other: Physical Activity (PA) Tracker App
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.

Other: Coach Me
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.

PA App + Proof Positive
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).
Other: Physical Activity (PA) Tracker App
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.

Other: Proof Positive
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.

PA App
Participants in this arm will use a basic physical activity (PA) tracker app without any additional features.
Other: Physical Activity (PA) Tracker App
This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.




Primary Outcome Measures :
  1. Change from baseline in Objective Physical Activity, as measured using the Patient Recorded Outcome Diary [ Time Frame: 3-day monitoring periods at baseline and 4 months ]
    Objective physical activity will be measured using the Patient Recorded Outcome Diary (PRO-Diary; CamNtech). The PRO-Diary is a wrist-worn accelerometer-based activity monitor comprised of upgraded Actiwatch-S (Mini Mitter Co) technology, and validly depicts daily, whole-body movement. (The Actiwatch-S predates the PRO-Diary and has demonstrated high reliability and validity in assessing free-living activity.) Older adults show high compliance with wearing wrist monitors across multiple days. Waking-hour data will be aggregated to create a single average activity count/day total to represent physical activity level.


Secondary Outcome Measures :
  1. Change from baseline in Sedentary Activity Time as measured using the Patient Recorded Outcome Diary [ Time Frame: 3-day monitoring periods at baseline and 4 months ]
    Objective sedentary activity time will be measured using the Patient Recorded Outcome Diary (PRO-Diary; CamNtech). The PRO-Diary is a wrist-worn accelerometer-based activity monitor comprised of upgraded Actiwatch-S (Mini Mitter Co) technology, and validly depicts daily, whole-body movement. (The Actiwatch-S predates the PRO-Diary and has demonstrated high reliability and validity in assessing free-living activity.) Older adults show high compliance with wearing wrist monitors across multiple days. Sedentary Activity time will include PRO-Diary recordings of <100 activity counts/minute and will be expressed as average hours/day.

  2. Change from baseline in the Physical Activity Scale for the Elderly (PASE) [ Time Frame: baseline and 4 months ]
    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.

  3. Change from baseline in a four-meter walk test [ Time Frame: baseline and 4 months ]
    Functional mobility will be assessed through a four-meter walk test, a commonly used, validated measure of physical and functional performance in older adults.

  4. Health Information Technology Usability Evaluation Scale (Health-ITUES) [ Time Frame: 4 months ]
    The Health-ITUES is a 20-item, Likert-style, customizable questionnaire designed to evaluate mHealth technology during system development and tap expectations for long-term impact, usefulness, ease of use, and user control. Health-ITUES has demonstrated construct validity and predictive validity for intention to use a mHealth system.

  5. Usage Rate [ Time Frame: from beginning of intervention to end of intervention (approximately 4 months) ]
    Usage rate (e.g., frequency of opening a feature) will be captured with the physical activity app.

  6. Change from baseline in the Health Beliefs Survey - Physical Activity Portion [ Time Frame: baseline and 4 months ]
    The potential mediators 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.

  7. Change from baseline in the Attitudes Toward Own Aging subscale of the Philadelphia Geriatrics Center Morale Scale [ Time Frame: baseline and 4 months ]
    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.

  8. Change from baseline in the Attitudes to Ageing Questionnaire [ Time Frame: baseline and 4 months ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 84 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • ≥85 years old, based on limited smartphone ownership and to reduce sample variability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417440


Contacts
Layout table for location contacts
Contact: Stacey Schepens Niemiec, PhD, OTR/L 323-442-2069 schepens@chan.usc.edu
Contact: Jeanine Blanchard, PhD, OTR/L 323-442-1827 jeanine@chan.usc.edu

Locations
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United States, California
Front Porch Center for Innovation and Wellbeing Recruiting
Glendale, California, United States, 91203
Contact: Davis Park, BA    818-254-4274    DPARK@frontporch.net   
University of Southern California Recruiting
Los Angeles, California, United States, 90089-9003
Contact: Stacey Schepens Niemiec, PhD, OTR/L    323-442-2069    schepens@usc.edu   
Contact: Jeanine Blanchard, PhD, OTR/L    323-442-1827    jeanine@chan.usc.edu   
Principal Investigator: Stacey Schepens Niemiec, PhD, OTR/L         
Sponsors and Collaborators
University of Southern California
National Institute on Aging (NIA)
University of California, Los Angeles

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Responsible Party: Stacey Lynn Schepens Niemiec, Assistant Professor of Research, University of Southern California
ClinicalTrials.gov Identifier: NCT03417440     History of Changes
Other Study ID Numbers: HS-16-00670
R21AG052838 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Final results and dataset will be made available no later than the publication of the main findings from the final dataset. The data will remain in the repository indefinitely.
Access Criteria: Persons accessing the data through the repository must agree to certain terms of use to include the following: (1) must use data for research purposes only and not for investigation of specific research subjects; (2) must make no use of the identity of any research subject discovered inadvertently, and to advise the repository of any such discovery; (3) must agree not to redistribute data or other materials without the written agreement; and (4) must reference the recommended bibliographic citation in any publication that employs resources provided by the repository. Authors of publications based on shared data are required to send citations of their published works to the repository for inclusion in a database of related publications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stacey Lynn Schepens Niemiec, University of Southern California:
smartphone app, physical activity, older adults