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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03124537
Other study ID # Appstudy#16130
Secondary ID 5P30AG048785
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2017
Est. completion date July 9, 2019

Study information

Verified date October 2020
Source Brandeis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date July 9, 2019
Est. primary completion date March 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States Brandeis University Waltham Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brandeis University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Steps Walked Number of steps recorded daily on the phone app, weekly step averages Daily for one month
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). Baseline and one month from the start of the intervention
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. Baseline and one month from the start of the intervention
Secondary Social Contact Through the App Number of participants who sent at least one text message via the app During the one month intervention
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. 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). Baseline and one month from the start of the intervention
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). Baseline and one month from the start of the intervention
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). Baseline and one month from the start of the intervention
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