NCT03417440

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

January 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 21, 2022

Completed
Last Updated

November 21, 2022

Status Verified

October 1, 2022

Enrollment Period

2.7 years

First QC Date

January 24, 2018

Results QC Date

June 7, 2022

Last Update Submit

October 27, 2022

Conditions

Keywords

smartphone app, physical activity, older adults

Outcome Measures

Primary Outcomes (1)

  • 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)

    72-hour monitoring periods at Month 4 relative to baseline

Secondary Outcomes (13)

  • Daily Sitting Time (activPAL) Change From Baseline to Month 4

    72-hour monitoring periods at Month 4 relative to baseline

  • Self-reported Physical Activity (PASE) Change From Baseline to Month 4

    baseline and 4 months

  • Gait Speed (4-m Walk Test) Change From Baseline to Month 4

    baseline and 4 months

  • Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline

    baseline and 4 months

  • Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline

    baseline and 4 months

  • +8 more secondary outcomes

Other Outcomes (1)

  • Correlation of Change in Daily Steps to Change in Hypothesized Mediators

    baseline to Month 4 change

Study Arms (8)

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).

Other: Physical Activity (PA) Tracker AppOther: On Your FeetOther: Coach MeOther: 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).

Other: Physical Activity (PA) Tracker AppOther: On Your FeetOther: 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).

Other: Physical Activity (PA) Tracker AppOther: On Your FeetOther: 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).

Other: Physical Activity (PA) Tracker AppOther: 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).

Other: Physical Activity (PA) Tracker AppOther: Coach MeOther: 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).

Other: Physical Activity (PA) Tracker AppOther: 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).

Other: Physical Activity (PA) Tracker AppOther: Proof Positive

PA App

OTHER

Participants in this arm will use a basic physical activity (PA) tracker app without any additional features.

Other: Physical Activity (PA) Tracker App

Interventions

This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.

PA AppPA App + Coach MePA App + Coach Me + Proof PositivePA App + On Your FeetPA App + On Your Feet + Coach MePA App + On Your Feet + Proof PositivePA App + Proof PositivePA App+ On Your Feet+ CoachMe+ Proof Pos

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 + On Your FeetPA App + On Your Feet + Coach MePA App + On Your Feet + Proof PositivePA App+ On Your Feet+ CoachMe+ Proof Pos

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 + Coach MePA App + Coach Me + Proof PositivePA App + On Your Feet + Coach MePA App+ On Your Feet+ CoachMe+ Proof Pos

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 + Proof PositivePA App + On Your Feet + Proof PositivePA App + Proof PositivePA App+ On Your Feet+ CoachMe+ Proof Pos

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Front Porch Center for Innovation and Wellbeing

Glendale, California, 91203, United States

Location

University of Southern California

Los Angeles, California, 90089-9003, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Stacey Schepens Niemiec
Organization
University of Southern California Chan Division of OS-OT

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Research

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 31, 2018

Study Start

April 23, 2018

Primary Completion

January 12, 2021

Study Completion

January 12, 2021

Last Updated

November 21, 2022

Results First Posted

November 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

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.

Locations