- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03124537
Increasing Physical Activity Among Sedentary Older Adults:What, Where, When, and With Whom
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Waltham, Massachusetts, United States, 02454
- Brandeis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
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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.
|
|
Experimental: App Experimental condition
The experimental condition will set step goals and have the schedule, map, and social components for 1 month.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Steps Walked
Time Frame: Daily for one month
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Number of steps recorded daily on the phone app, weekly step averages
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Daily for one month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Self-efficacy
Time Frame: Baseline and one month from the start of the intervention
|
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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Baseline and one month from the start of the intervention
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Exercise Control Beliefs
Time Frame: Baseline and one month from the start of the intervention
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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.
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Baseline and one month from the start of the intervention
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Social Contact Through the App
Time Frame: During the one month intervention
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Number of participants who sent at least one text message via the app
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During the one month intervention
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Daily Mood and Energy Levels
Time Frame: Daily
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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.
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Daily
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Self-Reported Vigorous Physical Activity
Time Frame: Baseline and one month from the start of the intervention
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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).
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Baseline and one month from the start of the intervention
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Self-Reported Moderate Physical Activity
Time Frame: Baseline and one month from the start of the intervention
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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).
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Baseline and one month from the start of the intervention
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Self-Reported Light Physical Activity
Time Frame: Baseline and one month from the start of the intervention
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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).
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Baseline and one month from the start of the intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Margie Lachman, Ph.D., Brandeis University
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Appstudy#16130
- 5P30AG048785 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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