Sedentary Lifestyle
Conditions
Keywords
smartphone app, physical activity, older adults
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.
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.
Interventions
OTHERPhysical 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.
OTHEROn 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.
OTHERCoach 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.
OTHERProof 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.
Sponsors
National Institute on Aging (NIA)
University of California, Los Angeles
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, 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.
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 84 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Sitting Time (activPAL) Change From Baseline to Month 4 | 72-hour monitoring periods at Month 4 relative to baseline | Objective sedentary activity time was measured using the activPAL thigh-worn accelerometer during a 72-hour monitoring period. Expressed as average minutes/day. |
| Self-reported Physical Activity (PASE) Change From Baseline to Month 4 | 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. |
| Gait Speed (4-m Walk Test) Change From Baseline to Month 4 | 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. |
| Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline | baseline and 4 months | 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. |
| Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | baseline and 4 months | 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. |
| Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | baseline and 4 months | 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. |
| Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline | 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. Scores can range from 0 to 5. A higher score indicates more positive aging self-perceptions. |
| Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline | 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). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score for psychosocial loss indicates more negative attitude (min 8; max 40). |
| Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline | 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). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score on physical change indicates more positive attitude (min 8; max 40) |
| Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline | 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). Its subscales include psychosocial loss, physical change, and psychological growth. A higher score on psychological growth indicates more positive attitude (min 8; max 40). |
| App Usage Behavior | from baseline through Month 4 (daily) | Usage behavior is defined as the proportion of days the app was opened across the 4-month trial period |
| Perceived App Quality (uMARS) | 4 months | 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). |
| Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | baseline and 4 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Change in Daily Steps to Change in Hypothesized Mediators | baseline to Month 4 change | Spearman Correlation coefficients were calculated to assess correlations between change in the primary outcome (change in daily steps) and change in hypothesized mediators (i.e., Self-efficacy for Physical Activity Change, Self-regulation of Physical Activity Change, Family Social Support for Physical Activity Change, Outcome Expectation for Physical Activity Change, Aging Self-perceptions (Attitude Toward Own Aging) Change, Views of Aging--Psychosocial Loss Change, Views of Aging--Physical Change Change, Views of Aging--Psychological Growth Change). |
Countries
United States
Participant flow
Recruitment details
197 screened for eligibility. 111 signed consent. 107 were randomized. 105 included in intent-to-treat analysis.
Pre-assignment details
Two participants withdrew from the study after the study team randomized them but before the participants learned what group to which they were assigned. These two individuals were not included in the intent-to-treat analysis.
Participants by arm
| Arm | Count |
|---|---|
| AT App + On Your Feet+ CoachMe+ Proof Pos Basic physical activity tracker (AT) 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).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task. | 12 |
| AT App + On Your Feet + Coach Me Participants in this arm will use a basic physical activity tracker (AT) 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).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent. | 13 |
| AT App + On Your Feet + Proof Positive Participants in this arm will use a basic physical activity tracker (AT) 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).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task. | 13 |
| AT App + On Your Feet Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) On Your Feet (sedentary activity monitoring with motivational messaging and peer suggestions).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress.
On Your Feet: app feature designed reduce sedentary activity. Utilizes goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent; and general tips and strategies to reduce sedentary activity and messages about the benefits of reducing sedentary activity and overcoming barriers are sent. | 14 |
| AT App + Coach Me + Proof Positive Participants in this arm will use a basic physical activity tracker (AT) 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).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task. | 14 |
| AT App + Coach Me Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) Coach Me (tailored messaging to increase the intensity level of everyday activities and overcome barriers).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Coach Me: app feature designed to assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Tailored suggestions on how to intensify daily activities and how to overcome barriers are sent. | 12 |
| AT App + Proof Positive Participants in this arm will use a basic physical activity tracker (AT) app in conjunction with the following feature: (1) Proof Positive (explicit and implicit messaging to promote positive aging views).
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
Proof Positive: app feature capitalizes on the beneficial effects exposure to positive aging messages and stereotypes has on health. Users receive texts describing how old age does not equate to physical inability, information about the benefits of growing older, and positive aging stereotype task. | 15 |
| AT App Participants in this arm will use a basic physical activity tracker (AT) app without any additional features.
Activity Tracker App: app auto-monitors physical activity and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation. | 12 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 | 1 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | AT App + On Your Feet+ CoachMe+ Proof Pos | AT App + On Your Feet + Proof Positive | AT App + On Your Feet | AT App + Coach Me + Proof Positive | AT App + On Your Feet + Coach Me | AT App + Coach Me | AT App + Proof Positive | AT App | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 70.4 years STANDARD_DEVIATION 5.3 | 71.6 years STANDARD_DEVIATION 3.4 | 72.7 years STANDARD_DEVIATION 4.6 | 71.5 years STANDARD_DEVIATION 4.3 | 72.1 years STANDARD_DEVIATION 4.2 | 72.2 years STANDARD_DEVIATION 4.2 | 72.4 years STANDARD_DEVIATION 4.2 | 74.4 years STANDARD_DEVIATION 6.4 | 72.2 years STANDARD_DEVIATION 4.6 |
| Education College graduate | 9 Participants | 11 Participants | 13 Participants | 11 Participants | 6 Participants | 11 Participants | 11 Participants | 8 Participants | 80 Participants |
| Education High school or some college/trade school | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 7 Participants | 1 Participants | 4 Participants | 4 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 11 Participants | 14 Participants | 13 Participants | 13 Participants | 12 Participants | 15 Participants | 9 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Health Conditions Arthritis | 3 Participants | 7 Participants | 7 Participants | 3 Participants | 2 Participants | 5 Participants | 8 Participants | 3 Participants | 38 Participants |
| Health Conditions Cancer | 1 Participants | 2 Participants | 1 Participants | 4 Participants | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 23 Participants |
| Health Conditions Depression | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 3 Participants | 4 Participants | 4 Participants | 2 Participants | 19 Participants |
| Health Conditions Diabetes | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 0 Participants | 1 Participants | 14 Participants |
| Health Conditions High blood pressure | 6 Participants | 7 Participants | 7 Participants | 4 Participants | 6 Participants | 4 Participants | 4 Participants | 5 Participants | 43 Participants |
| Health Conditions High cholesterol | 6 Participants | 8 Participants | 6 Participants | 4 Participants | 7 Participants | 5 Participants | 4 Participants | 5 Participants | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 4 Participants | 1 Participants | 4 Participants | 3 Participants | 5 Participants | 3 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 8 Participants | 6 Participants | 10 Participants | 7 Participants | 9 Participants | 9 Participants | 8 Participants | 64 Participants |
| Region of Enrollment United States | 12 Participants | 13 Participants | 14 Participants | 14 Participants | 13 Participants | 12 Participants | 15 Participants | 12 Participants | 105 Participants |
| Self-rated smartphone ability | 7.6 units on a scale STANDARD_DEVIATION 1.8 | 7.2 units on a scale STANDARD_DEVIATION 1.3 | 7.1 units on a scale STANDARD_DEVIATION 1.4 | 7.8 units on a scale STANDARD_DEVIATION 2.1 | 7.2 units on a scale STANDARD_DEVIATION 2.7 | 6.5 units on a scale STANDARD_DEVIATION 1.5 | 7.0 units on a scale STANDARD_DEVIATION 2.1 | 6.3 units on a scale STANDARD_DEVIATION 2.1 | 7.1 units on a scale STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 8 Participants | 9 Participants | 8 Participants | 11 Participants | 12 Participants | 11 Participants | 77 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 6 Participants | 5 Participants | 5 Participants | 1 Participants | 3 Participants | 1 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 14 | 0 / 14 | 0 / 12 | 0 / 15 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 14 | 0 / 14 | 1 / 12 | 0 / 15 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 14 | 0 / 14 | 0 / 12 | 0 / 15 | 0 / 12 |
Outcome results
Primary
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)
Time frame: 72-hour monitoring periods at Month 4 relative to baseline
Population: ITT population: all randomized participants who started the intervention and who had at least one valid activity monitoring period. Participants included underactive older adults who own a smartphone. Change in physical activity patterns of these individuals was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions | -343.5 Average change in steps per day | Standard Deviation 2689.5 |
| Proof Positive Off | Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions | -324.5 Average change in steps per day | Standard Deviation 2263.1 |
| Coach Me On | Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions | -859.9 Average change in steps per day | Standard Deviation 2588.6 |
| Coach Me Off | Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions | 149.5 Average change in steps per day | Standard Deviation 2289.6 |
| On Your Feet On | Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions | -424.8 Average change in steps per day | Standard Deviation 2101.2 |
| On Your Feet Off | Daily Steps Change From Baseline to Month 4; Main Effect, and 2- and 3-way Interactions | -243.5 Average change in steps per day | Standard Deviation 2822.8 |
Comparison: The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.p-value: 0.3795% CI: [-2884.82, 1088.82]Mixed Models Analysis
Comparison: The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.p-value: 0.0295% CI: [-4687.44, -516.69]Mixed Models Analysis
Comparison: The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.p-value: 0.2395% CI: [-3287.6, 797.85]Mixed Models Analysis
Comparison: The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.p-value: 0.3195% CI: [-1368.93, 4306.02]Mixed Models Analysis
Comparison: The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.p-value: 0.7895% CI: [-2397.51, 3173.62]Mixed Models Analysis
Comparison: The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.p-value: 0.1795% CI: [-865.52, 4847.86]Mixed Models Analysis
Comparison: The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.p-value: 0.7795% CI: [-4591.17, 3409.75]Mixed Models Analysis
Secondary
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.
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline | 0.2 score on a scale | Standard Deviation 1.1 |
| Proof Positive Off | Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline | 0.4 score on a scale | Standard Deviation 1.1 |
| Coach Me On | Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline | 0.1 score on a scale | Standard Deviation 0.9 |
| Coach Me Off | Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline | 0.5 score on a scale | Standard Deviation 1.3 |
| On Your Feet On | Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline | 0.4 score on a scale | Standard Deviation 1.2 |
| On Your Feet Off | Aging Self-perceptions (Attitudes Toward Own Aging) Change From Baseline | 0.2 score on a scale | Standard Deviation 1 |
p-value: 0.78t-test, 1 sided
p-value: 0.98t-test, 1 sided
p-value: 0.13t-test, 1 sided
Secondary
App Usage Behavior
Usage behavior is defined as the proportion of days the app was opened across the 4-month trial period
Time frame: from baseline through Month 4 (daily)
Population: ITT population: all randomized participants who started the intervention and who had at least one app usage data point. Participants included underactive older adults who own a smartphone.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | App Usage Behavior | 0.73 proportion of days | Standard Deviation 0.28 |
| Proof Positive Off | App Usage Behavior | 0.68 proportion of days | Standard Deviation 0.29 |
| Coach Me On | App Usage Behavior | 0.71 proportion of days | Standard Deviation 0.29 |
| Coach Me Off | App Usage Behavior | 0.71 proportion of days | Standard Deviation 0.28 |
| On Your Feet On | App Usage Behavior | 0.68 proportion of days | Standard Deviation 0.3 |
| On Your Feet Off | App Usage Behavior | 0.73 proportion of days | Standard Deviation 0.27 |
p-value: 0.84t-test, 2 sided
p-value: 0.96t-test, 2 sided
p-value: 0.41t-test, 2 sided
Secondary
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.
Time frame: 72-hour monitoring periods at Month 4 relative to baseline
Population: ITT population: all randomized participants who started the intervention and who had valid activity monitoring periods at baseline and post-test. Participants included underactive older adults who own a smartphone. Change in physical activity patterns of these individuals was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Daily Sitting Time (activPAL) Change From Baseline to Month 4 | -11.6 Change in minutes/day | Standard Deviation 108.1 |
| Proof Positive Off | Daily Sitting Time (activPAL) Change From Baseline to Month 4 | 11.4 Change in minutes/day | Standard Deviation 128.9 |
| Coach Me On | Daily Sitting Time (activPAL) Change From Baseline to Month 4 | 19.3 Change in minutes/day | Standard Deviation 123.6 |
| Coach Me Off | Daily Sitting Time (activPAL) Change From Baseline to Month 4 | -18.4 Change in minutes/day | Standard Deviation 112.2 |
| On Your Feet On | Daily Sitting Time (activPAL) Change From Baseline to Month 4 | 25.7 Change in minutes/day | Standard Deviation 117.3 |
| On Your Feet Off | Daily Sitting Time (activPAL) Change From Baseline to Month 4 | -26.3 Change in minutes/day | Standard Deviation 115.5 |
p-value: 0.17t-test, 1 sided
p-value: 0.94t-test, 1 sided
p-value: 0.99t-test, 1 sided
Secondary
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.
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.2 score on a scale | Standard Deviation 1.2 |
| Proof Positive Off | Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.2 score on a scale | Standard Deviation 1.3 |
| Coach Me On | Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | -0.0 score on a scale | Standard Deviation 1.1 |
| Coach Me Off | Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.4 score on a scale | Standard Deviation 1.3 |
| On Your Feet On | Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.2 score on a scale | Standard Deviation 1.1 |
| On Your Feet Off | Family Social Support for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.2 score on a scale | Standard Deviation 1.4 |
p-value: 0.46t-test, 1 sided
p-value: 0.96t-test, 1 sided
p-value: 0.495t-test, 1 sided
Secondary
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.
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had walk test data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured. Note: very few data were available due to COVID-19 restrictions negating continuation of data collection for this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Gait Speed (4-m Walk Test) Change From Baseline to Month 4 | -0.7 meters/second | Standard Deviation 0.9 |
| Proof Positive Off | Gait Speed (4-m Walk Test) Change From Baseline to Month 4 | -0.1 meters/second | Standard Deviation 1 |
| Coach Me On | Gait Speed (4-m Walk Test) Change From Baseline to Month 4 | -0.2 meters/second | Standard Deviation 1.2 |
| Coach Me Off | Gait Speed (4-m Walk Test) Change From Baseline to Month 4 | -0.4 meters/second | Standard Deviation 0.9 |
| On Your Feet On | Gait Speed (4-m Walk Test) Change From Baseline to Month 4 | -0.5 meters/second | Standard Deviation 1 |
| On Your Feet Off | Gait Speed (4-m Walk Test) Change From Baseline to Month 4 | -0.2 meters/second | Standard Deviation 1 |
p-value: 0.86t-test, 1 sided
p-value: 0.38t-test, 1 sided
p-value: 0.66t-test, 1 sided
Secondary
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
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | -0.4 score on a scale | Standard Deviation 4.2 |
| Proof Positive Off | Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | -0.5 score on a scale | Standard Deviation 4.8 |
| Coach Me On | Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | -1.1 score on a scale | Standard Deviation 4 |
| Coach Me Off | Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.2 score on a scale | Standard Deviation 4.8 |
| On Your Feet On | Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | -0.1 score on a scale | Standard Deviation 3.8 |
| On Your Feet Off | Outcome Expectation for Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | -0.8 score on a scale | Standard Deviation 5 |
p-value: 0.445t-test, 1 sided
p-value: 0.92t-test, 1 sided
p-value: 0.23t-test, 1 sided
Secondary
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).
Time frame: 4 months
Population: ITT population: all randomized participants who had valid questionnaire data at post-test. Participants included underactive older adults who own a smartphone.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Perceived App Quality (uMARS) | 3.8 score on a scale | Standard Deviation 0.5 |
| Proof Positive Off | Perceived App Quality (uMARS) | 4.0 score on a scale | Standard Deviation 0.6 |
| Coach Me On | Perceived App Quality (uMARS) | 3.9 score on a scale | Standard Deviation 0.5 |
| Coach Me Off | Perceived App Quality (uMARS) | 4.0 score on a scale | Standard Deviation 0.5 |
| On Your Feet On | Perceived App Quality (uMARS) | 4.0 score on a scale | Standard Deviation 0.5 |
| On Your Feet Off | Perceived App Quality (uMARS) | 3.9 score on a scale | Standard Deviation 0.5 |
p-value: 0.13t-test, 2 sided
p-value: 0.2t-test, 2 sided
p-value: 0.39t-test, 2 sided
Secondary
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.
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline | -4.8 units on a scale | Standard Deviation 18.5 |
| Proof Positive Off | Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline | -2.9 units on a scale | Standard Deviation 19.8 |
| Coach Me On | Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline | -4.4 units on a scale | Standard Deviation 17.4 |
| Coach Me Off | Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline | -3.4 units on a scale | Standard Deviation 20.7 |
| On Your Feet On | Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline | -1.4 units on a scale | Standard Deviation 16.7 |
| On Your Feet Off | Self-efficacy for Physical Activity (Health Beliefs Survey) Change From Baseline | -6.2 units on a scale | Standard Deviation 21 |
p-value: 0.69t-test, 1 sided
p-value: 0.6t-test, 1 sided
p-value: 0.11t-test, 1 sided
Secondary
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.
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.8 score on a scale | Standard Deviation 1 |
| Proof Positive Off | Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 1.2 score on a scale | Standard Deviation 1 |
| Coach Me On | Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.9 score on a scale | Standard Deviation 1 |
| Coach Me Off | Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 1.0 score on a scale | Standard Deviation 1.1 |
| On Your Feet On | Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 1.1 score on a scale | Standard Deviation 1.2 |
| On Your Feet Off | Self-regulation of Physical Activity (Health Beliefs Survey Physical Activity Portion) Change From Baseline | 0.9 score on a scale | Standard Deviation 0.9 |
p-value: 0.94t-test, 1 sided
p-value: 0.73t-test, 1 sided
p-value: 0.22t-test, 1 sided
Secondary
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.
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change in physical activity patterns of these individuals was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Self-reported Physical Activity (PASE) Change From Baseline to Month 4 | 4.0 score on a scale | Standard Deviation 41.6 |
| Proof Positive Off | Self-reported Physical Activity (PASE) Change From Baseline to Month 4 | 3.2 score on a scale | Standard Deviation 59.3 |
| Coach Me On | Self-reported Physical Activity (PASE) Change From Baseline to Month 4 | 6.2 score on a scale | Standard Deviation 44.2 |
| Coach Me Off | Self-reported Physical Activity (PASE) Change From Baseline to Month 4 | 1.2 score on a scale | Standard Deviation 56.5 |
| On Your Feet On | Self-reported Physical Activity (PASE) Change From Baseline to Month 4 | 5.6 score on a scale | Standard Deviation 54.4 |
| On Your Feet Off | Self-reported Physical Activity (PASE) Change From Baseline to Month 4 | 1.7 score on a scale | Standard Deviation 47.5 |
p-value: 0.47t-test, 1 sided
p-value: 0.315t-test, 1 sided
p-value: 0.355t-test, 1 sided
Secondary
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)
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline | 0.6 score on a scale | Standard Deviation 4.2 |
| Proof Positive Off | Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline | 0.4 score on a scale | Standard Deviation 4.1 |
| Coach Me On | Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline | 0.1 score on a scale | Standard Deviation 3.2 |
| Coach Me Off | Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline | 0.9 score on a scale | Standard Deviation 4.9 |
| On Your Feet On | Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline | 0.5 score on a scale | Standard Deviation 4.6 |
| On Your Feet Off | Views of Aging--Physical Change (Attitudes to Ageing Questionnaire) Change From Baseline | 0.6 score on a scale | Standard Deviation 3.7 |
p-value: 0.42t-test, 1 sided
p-value: 0.82t-test, 1 sided
p-value: 0.58t-test, 1 sided
Secondary
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).
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline | 0.0 score on a scale | Standard Deviation 4 |
| Proof Positive Off | Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline | -0.1 score on a scale | Standard Deviation 3.9 |
| Coach Me On | Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline | -0.0 score on a scale | Standard Deviation 3.7 |
| Coach Me Off | Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline | -0.0 score on a scale | Standard Deviation 4.1 |
| On Your Feet On | Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline | -0.1 score on a scale | Standard Deviation 4.1 |
| On Your Feet Off | Views of Aging--Psychological Growth (Attitudes to Ageing Questionnaire) Change From Baseline | 0.1 score on a scale | Standard Deviation 3.7 |
p-value: 0.45t-test, 1 sided
p-value: 0.49t-test, 1 sided
p-value: 0.61t-test, 1 sided
Secondary
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).
Time frame: baseline and 4 months
Population: ITT population: all randomized participants who started the intervention and who had valid questionnaire data at baseline and post-test. Participants included underactive older adults who own a smartphone. Change was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Proof Positive On | Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline | -0.6 score on a scale | Standard Deviation 3.8 |
| Proof Positive Off | Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline | -0.1 score on a scale | Standard Deviation 4.8 |
| Coach Me On | Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline | -0.3 score on a scale | Standard Deviation 5 |
| Coach Me Off | Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline | -0.3 score on a scale | Standard Deviation 3.6 |
| On Your Feet On | Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline | 0.3 score on a scale | Standard Deviation 4 |
| On Your Feet Off | Views of Aging--Psychosocial Loss (Attitudes to Ageing Questionnaire) Change From Baseline | -0.9 score on a scale | Standard Deviation 4.5 |
p-value: 0.285t-test, 1 sided
p-value: 0.5t-test, 1 sided
p-value: 0.92t-test, 1 sided
Other Pre-specified
Correlation of Change in Daily Steps to Change in Hypothesized Mediators
Spearman Correlation coefficients were calculated to assess correlations between change in the primary outcome (change in daily steps) and change in hypothesized mediators (i.e., Self-efficacy for Physical Activity Change, Self-regulation of Physical Activity Change, Family Social Support for Physical Activity Change, Outcome Expectation for Physical Activity Change, Aging Self-perceptions (Attitude Toward Own Aging) Change, Views of Aging--Psychosocial Loss Change, Views of Aging--Physical Change Change, Views of Aging--Psychological Growth Change).
Time frame: baseline to Month 4 change
Population: ITT population: all randomized subjects who started the intervention and had both pre- and post-test values were considered for analyses. Missing values were excluded pairwise within the correlation matrix (i.e., If a data point was missing from either a hypothesized mediator (e.g., family social support for physical activity) OR from activity monitor steps data, then the subject's data point was not included in that particular correlational analysis. Data points available range n=91 to n=96.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Proof Positive On | Correlation of Change in Daily Steps to Change in Hypothesized Mediators | Self-efficacy for Physical Activity Change | -4.8 change in daily steps |
| Proof Positive On | Correlation of Change in Daily Steps to Change in Hypothesized Mediators | Self-regulation of Physical Activity Change | 0.8 change in daily steps |
| Proof Positive On | Correlation of Change in Daily Steps to Change in Hypothesized Mediators | Family Social Support for Physical Activity Change | 0.1 change in daily steps |
| Proof Positive On | Correlation of Change in Daily Steps to Change in Hypothesized Mediators | Outcome Expectation for Physical Activity Change | 0.0 change in daily steps |
| Proof Positive On | Correlation of Change in Daily Steps to Change in Hypothesized Mediators | Aging Self-perceptions (Attitude Toward Own Aging) Change | 0.0 change in daily steps |
| Proof Positive On | Correlation of Change in Daily Steps to Change in Hypothesized Mediators | Views of Aging--Psychosocial Loss Change | 0.0 change in daily steps |
| Proof Positive On | Correlation of Change in Daily Steps to Change in Hypothesized Mediators | Views of Aging--Physical Change Change | 0.0 change in daily steps |
| Proof Positive On | Correlation of Change in Daily Steps to Change in Hypothesized Mediators | Views of Aging--Psychological Growth Change | 0.0 change in daily steps |
Comparison: Correlation between Self-efficacy for Physical Activity change and Daily Steps change across 4 months.p-value: 0.3116t distribution with n-2 degrees of freed
Comparison: Correlation between Correlation between Self-regulation of Physical Activity change and Daily Steps change across 4 months.p-value: 0.0838t distribution with n-2 degrees of freed
Comparison: Correlation between Family Social Support for Physical Activity change and Daily Steps change across 4 months.p-value: 0.351t distribution with n-2 degrees of freed
Comparison: Correlation between Outcome Expectation for Physical Activity change and Daily Steps change across 4 months.p-value: 0.6659t distribution with n-2 degrees of freed
Comparison: Correlation between Aging Self-perceptions (Attitude Toward Own Aging) change and Daily Steps change across 4 months.p-value: 0.6402t distribution with n-2 degrees of freed
Comparison: Correlation between Views of Aging--Psychosocial Loss change and Daily Steps change across 4 months.p-value: 0.2048t distribution with n-2 degrees of freed
Comparison: Correlation between Views of Aging--Physical Change change and Daily Steps change across 4 months.p-value: 0.3445t distribution with n-2 degrees of freed
Comparison: Correlation between Views of Aging--Psychological Growth change and Daily Steps change across 4 months.p-value: 0.934t distribution with n-2 degrees of freed