Sedentary LifestyleNCT03124537
Increasing Physical Activity Among Sedentary Older Adults:What, Where, When, and With Whom
A study testing App Experimental condition in people with Sedentary Lifestyle and Self Efficacy, run by Brandeis University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Self Efficacy, Control Locus
- What is being tested?
- App Experimental condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 9 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary adults, who own an iphone with step-tracking capabilities (5s or later).
- Participants must be fit enough to walk for at least 20 minutes at a time.
Who cannot join
- Cognitive impairment
- A recent (within the past 6 months) cardiovascular event, or fall.
- A doctor has advised them not to walk
- Anyone who already exercises regularly: walks for exercise more than 30 minutes per day, or does other forms of exercise 150 minutes per week or more, will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Sedentary Lifestyle, Self Efficacy, Control Locus, Aging
- Being tested
- App Experimental condition, App Condition Control
- Keywords
- Physical Exercise, Behavior Change
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App Experimental conditionBehavioural
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.
App Condition ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: App Condition Control |
| App Experimental condition | Experimental | The experimental condition will set step goals and have the schedule, map, and social components for 1 month. Receives: Behavioral: App Experimental condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Steps Walked
Number of steps recorded daily on the phone app, weekly step averages
Measured: Daily for one month
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and one month from the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start16 Oct 2017
- Primary completion29 Mar 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brandeis University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Margie Lachman, Brandeis University
- Investigators
- Margie Lachman, Ph.D., Principal investigator, Brandeis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124537
- Sponsor's protocol ID
- Appstudy#16130
- Other IDs
- 5P30AG048785
- Status last verified
- Oct 2020
- First submitted
- 13 Apr 2017
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28123997Bisson 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.
PubMed 34855609
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity Among Sedentary Older Adults:What, Where, When, and With Whom
- ClinicalTrials.gov ID
- NCT03124537
- Acronym / sponsor ID
- Appstudy#16130
- Conditions
- Sedentary Lifestyle, Self Efficacy, Control Locus, Aging
- Keywords
- Physical Exercise, Behavior Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Brandeis UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| App Control Condition | Experimental | Behavioral: App Condition ControlThe 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 Experimental condition | Experimental | Behavioral: App Experimental conditionThe experimental condition will set step goals and have the schedule, map, and social components for 1 month. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sedentary adults, who own an iphone with step-tracking capabilities (5s or later).
- Participants must be fit enough to walk for at least 20 minutes at a time.
Key exclusion criteria (4 listed)
- Cognitive impairment
- A recent (within the past 6 months) cardiovascular event, or fall.
- A doctor has advised them not to walk
- Anyone who already exercises regularly: walks for exercise more than 30 minutes per day, or does other forms of exercise 150 minutes per week or more, will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App Experimental conditionThis 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. | Behavioural | App Experimental condition |
| App Condition ControlThis 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. | Behavioural | App Control Condition |
Primary outcome
Number of Steps Walked
Time frame: Daily for one month
Number of steps recorded daily on the phone app, weekly step averages
7 secondary outcomes
Exercise Self-efficacy
Time frame: Baseline and one month from the start of the intervention
Exercise Control Beliefs
Time frame: Baseline and one month from the start of the intervention
Social Contact Through the App
Time frame: During the one month intervention
Daily Mood and Energy Levels
Time frame: Daily
Self-Reported Vigorous Physical Activity
Time frame: Baseline and one month from the start of the intervention
Self-Reported Moderate Physical Activity
Time frame: Baseline and one month from the start of the intervention
Self-Reported Light Physical Activity
Time frame: Baseline and one month from the start of the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28123997Sullivan 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.
- Derived from this study: PubMed 34855609Bisson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margie Lachman, Ph.D. principal investigator
Brandeis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App Experimental condition in people with Sedentary Lifestyle and Self Efficacy, run by Brandeis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Steps Walked (time frame: Daily for one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124537, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.