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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG048785 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this study is to develop a smart phone app to administer a behavior change program that helps adults to increase daily steps by planning where, when, and with whom to walk. The investigators tested the effectiveness of the walking program app for increasing the number of daily steps among sedentary older adults. The investigators examined the effects on self-efficacy and social integration/support.
Physical activity is broadly beneficial for physical, psychological, and cognitive aspects of health, yet only one in five U.S. adults meets the CDC physical activity guidelines. Making physical activity accessible and feasible throughout life is an important public health policy objective that is within reach with the right kind of behavioral and environmental supports. The project aims to provide such supports for an active lifestyle thereby contributing to healthy aging. The goal of this project is to increase physical activity (i.e., walking) in sedentary older adults by providing the environmental and behavioral resources to incorporate additional steps into their daily lives. The investigators used a behavioral approach that fosters a sense of control and facilitates planning by focusing on the what, when, where, and with whom aspects of their physical activity. The investigators proposed a user-friendly, practical way to increase steps. By providing people with specific, tailored information about the number of steps one can get by walking a certain distance or during a certain amount of time, participants can better plan when, where, and with whom they will be able to achieve the desired number of steps, break goals into manageable portions (at different times throughout the day or week), and thereby increase the likelihood of goal achievement.
During the app development phase, the investigators demonstrated the app to 10 older adults to get their input. The goal was to get their feedback about the app features and to make sure it is user friendly. The investigators asked questions about the ease of using the app and their understanding of the app features. The interviewer recorded their answers to share with the research team and app developer. Modifications to the app were made based on the feedback.
During the next phase of the study, the investigators tested whether the full app program was successful in increasing steps and whether it was more effective than the basic app that only includes step counting and goals, similar to a fitness tracker or pedometer. Sixty participants were randomly assigned to two conditions: the app with step counting and goals alone (control), or the full version of the app with the step counting and goals, schedule, maps, and social components (experimental). It was predicted that the intervention group would improve more on outcome measures than the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App Control Condition | Experimental | The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month |
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| App Experimental condition | Experimental | The experimental condition will set step goals and have the schedule, map, and social components for 1 month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App Experimental condition | Behavioral | This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Steps Walked | Number of steps recorded daily on the phone app, weekly step averages | Daily for one month |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Self-efficacy | A modified version of Bandura's Exercise Self-Efficacy scale (Bandura, 1997) was used in the current study. This 9-item scale assesses how sure one is that they would exercise under different conditions or constraints (e.g. How sure are you that you will exercise when you are feeling down or depressed?), with answer choices ranging from not sure at all (1) to very sure (4). The 9 items are averaged to create a composite score, where a higher score indicates greater exercise self-efficacy (Neupert et al., 2009). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margie Lachman, Ph.D. | Brandeis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brandeis University | Waltham | Massachusetts | 02454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28123997 | Background | Sullivan AN, Lachman ME. Behavior Change with Fitness Technology in Sedentary Adults: A Review of the Evidence for Increasing Physical Activity. Front Public Health. 2017 Jan 11;4:289. doi: 10.3389/fpubh.2016.00289. eCollection 2016. | |
| 34855609 | Derived | Bisson AN, Sorrentino V, Lachman ME. Walking and Daily Affect Among Sedentary Older Adults Measured Using the StepMATE App: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 1;9(12):e27208. doi: 10.2196/27208. |
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| ID | Title | Description |
|---|---|---|
| FG000 | App Control Condition | The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month App Condition Control: This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels. |
| FG001 | App Experimental Condition | The experimental condition will set step goals and have the schedule, map, and social components for 1 month. App Experimental condition: This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | App Control Condition | The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month App Condition Control: This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Steps Walked | Number of steps recorded daily on the phone app, weekly step averages | Participants were excluded if they dropped out of the study or experienced the app crash. Analyses were conducted using an intent to treat population. Daily step averages less than 500 steps were classified as a missing day of data. Weekly step averages were only calculated if there were 4 or more days of valid data. | Posted | Mean | Standard Deviation | Average Daily Steps | Daily for one month |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | App Control Condition | The control group will just have the App with the accelerometer program to set step goals and to count and record steps for 1 month App Condition Control: This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alycia Bisson | Brandeis University | 781 736 3284 | lifespanlab@brandeis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2018 | May 13, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2018 | May 13, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Both conditions will receive the App for use on an iphone. The control group will just have the accelerometer program to set step goals and to count steps. The experimental condition will have the accelerometer to set goals and count steps in addition to the schedule, map and social components.
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The participants are aware of the nature of the App features they are given. They are not aware of whether they are in an experimental or control condition.
|
| App Condition Control | Behavioral | This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels. |
|
| Baseline and one month from the start of the intervention |
| Exercise Control Beliefs | Control over exercise was measured using the 6-item Exercise Control Beliefs Scale (Neupert, Lachman, & Whitbourne, 2009). Items assess the beliefs about one's control over exercise (e.g., I am confident in my ability to do an exercise routine), with answer choices ranging from strongly disagree (1) to strongly agree (5). The 6 items are averaged to create a mean exercise control score, with a higher score indicating greater control over exercise. | Baseline and one month from the start of the intervention |
| Social Contact Through the App | Number of participants who sent at least one text message via the app | During the one month intervention |
| Daily Mood and Energy Levels | Twice at random times, each day, mood and energy levels were assessed. A popup notification asked participants to rate their current mood (unhappy, neutral, happy) and energy (low, neutral, high) on a slider scale. Scores were converted by the StepMATE app to a 0-10 scale, with 0 indicating low mood/energy, and 10 indicating high mood/energy. If both mood and energy assessments were completed in one day, they were averaged to create daily average scores, one for mood and one for energy. Data presented below are the average of all daily scores across the month, while daily averages were used in the analyses. | Daily |
| Self-Reported Vigorous Physical Activity | Vigorous PA was measured using the question 'How often do you engage in vigorous physical activity that causes your heart to beat so rapidly that you can feel it in your chest and you perform the activity long enough to work up a good sweat and are breathing heavily?', with answer choices ranging from never (0) to several times a week (5). | Baseline and one month from the start of the intervention |
| Self-Reported Moderate Physical Activity | Moderate PA was measured with the question 'How often do you engage in moderate physical activity that is not physically exhausting, but it causes your heart rate to increase slightly and you typically work up a sweat?', with answer choices ranging from never (0) to several times a week (5). | Baseline and one month from the start of the intervention |
| Self-Reported Light Physical Activity | Light PA was measured using the question 'How often do you engage in light physical activity that requires little physical effort?', with answer choices ranging from never (0) to several times a week (5). | Baseline and one month from the start of the intervention |
| BG001 | App Experimental Condition | The experimental condition will set step goals and have the schedule, map, and social components for 1 month. App Experimental condition: This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | App Experimental Condition | The experimental condition will set step goals and have the schedule, map, and social components for 1 month. App Experimental condition: This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels. |
|
|
|
| Secondary | Exercise Self-efficacy | A modified version of Bandura's Exercise Self-Efficacy scale (Bandura, 1997) was used in the current study. This 9-item scale assesses how sure one is that they would exercise under different conditions or constraints (e.g. How sure are you that you will exercise when you are feeling down or depressed?), with answer choices ranging from not sure at all (1) to very sure (4). The 9 items are averaged to create a composite score, where a higher score indicates greater exercise self-efficacy (Neupert et al., 2009). | Posted | Mean | Standard Deviation | units on a scale | Baseline and one month from the start of the intervention |
|
|
|
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| Secondary | Exercise Control Beliefs | Control over exercise was measured using the 6-item Exercise Control Beliefs Scale (Neupert, Lachman, & Whitbourne, 2009). Items assess the beliefs about one's control over exercise (e.g., I am confident in my ability to do an exercise routine), with answer choices ranging from strongly disagree (1) to strongly agree (5). The 6 items are averaged to create a mean exercise control score, with a higher score indicating greater control over exercise. | Posted | Mean | Standard Deviation | units on a scale | Baseline and one month from the start of the intervention |
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| Secondary | Social Contact Through the App | Number of participants who sent at least one text message via the app | Posted | Number | participants | During the one month intervention |
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| Secondary | Daily Mood and Energy Levels | Twice at random times, each day, mood and energy levels were assessed. A popup notification asked participants to rate their current mood (unhappy, neutral, happy) and energy (low, neutral, high) on a slider scale. Scores were converted by the StepMATE app to a 0-10 scale, with 0 indicating low mood/energy, and 10 indicating high mood/energy. If both mood and energy assessments were completed in one day, they were averaged to create daily average scores, one for mood and one for energy. Data presented below are the average of all daily scores across the month, while daily averages were used in the analyses. | Posted | Mean | Standard Deviation | units on a scale | Daily |
|
|
|
|
| Secondary | Self-Reported Vigorous Physical Activity | Vigorous PA was measured using the question 'How often do you engage in vigorous physical activity that causes your heart to beat so rapidly that you can feel it in your chest and you perform the activity long enough to work up a good sweat and are breathing heavily?', with answer choices ranging from never (0) to several times a week (5). | Posted | Mean | Standard Deviation | units on a scale | Baseline and one month from the start of the intervention |
|
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|
|
| Secondary | Self-Reported Moderate Physical Activity | Moderate PA was measured with the question 'How often do you engage in moderate physical activity that is not physically exhausting, but it causes your heart rate to increase slightly and you typically work up a sweat?', with answer choices ranging from never (0) to several times a week (5). | Posted | Mean | Standard Deviation | units on a scale | Baseline and one month from the start of the intervention |
|
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|
|
| Secondary | Self-Reported Light Physical Activity | Light PA was measured using the question 'How often do you engage in light physical activity that requires little physical effort?', with answer choices ranging from never (0) to several times a week (5). | Posted | Mean | Standard Deviation | units on a scale | Baseline and one month from the start of the intervention |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | App Experimental Condition | The experimental condition will set step goals and have the schedule, map, and social components for 1 month. App Experimental condition: This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels. | 0 | 45 | 0 | 45 | 0 | 45 |
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Tested whether exercise self efficacy increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).
| Mixed Models Analysis |
Controlling for age, sex, education, and health. |
| .361 |
| Superiority |
Tested whether exercise control belief increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).
| Mixed Models Analysis |
Controlling for age, sex, education, and health. |
| .641 |
| Superiority |
| Mixed Models Analysis |
Controlling for age, condition, education, health, and average steps. |
| .003 |
| Superiority |
| Tested whether the relationship between daily walking and mood differed between males and females (steps by sex interaction). | Mixed Models Analysis | Controlling for age, sex, condition, education, health, and average steps. | < .001 | Superiority |
| Tested whether the relationship between daily walking and energy differed between males and females (steps by sex interaction). | Mixed Models Analysis | Controlling for age, condition, education, health, and average steps. | < .001 | Superiority |
Tested whether self-reported vigorous physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction). |
| Mixed Models Analysis |
Controlling for age, sex, education, and health. |
| .232 |
| Superiority |
Tested whether self-reported moderate physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction). |
| Mixed Models Analysis |
Controlling for age, sex, education, and health. |
| .831 |
| Superiority |
Tested whether self-reported light physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).
| Mixed Models Analysis |
Controlling for age, sex, education, and health. |
| .203 |
| Superiority |