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NCT03124537

Increasing Physical Activity Among Sedentary Older Adults:What, Where, When, and With Whom

Completed NA Results posted Last updated 20 October 2020
What this trial tests

NA trial testing App Experimental condition in Sedentary Lifestyle in 86 participants. Completed in 9 July 2019.

Timeline
16 October 2017
Primary endpoint
29 March 2019
9 July 2019

Quick facts

Lead sponsorBrandeis University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment86
Start date16 October 2017
Primary completion29 March 2019
Estimated completion9 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brandeis University

Who can join

50 and older, any sex, with Sedentary Lifestyle or Self Efficacy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Steps Walked Primary · Daily for one month

Number of steps recorded daily on the phone app, weekly step averages

Baseline Steps
GroupValue95% CI
App Control Condition3910.37± 2971.40
App Experimental Condition3477.66± 1749.29
Week 1 Steps
GroupValue95% CI
App Control Condition5744.00± 2398.89
App Experimental Condition5279.66± 2445.76
Week 2 Steps
GroupValue95% CI
App Control Condition5317.08± 2249.66
App Experimental Condition5116.88± 2983.89
Week 3 Steps
GroupValue95% CI
App Control Condition5858.90± 2446.95
App Experimental Condition5197.21± 2968.79
Week 4 Steps
GroupValue95% CI
App Control Condition5155.42± 2505.59
App Experimental Condition5285.26± 3493.65
Exercise Self-efficacy Secondary · 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).

Pre-test
GroupValue95% CI
App Control Condition2.61± 0.67
App Experimental Condition2.88± 0.83
Post-test
GroupValue95% CI
App Control Condition2.43± 0.83
App Experimental Condition2.54± 0.92
Exercise Control Beliefs Secondary · Baseline and one month from the start of the intervention

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.

Pre-test
GroupValue95% CI
App Control Condition4.39± 0.48
App Experimental Condition4.23± 0.53
Post-test
GroupValue95% CI
App Control Condition4.31± 0.51
App Experimental Condition4.25± 0.62
Social Contact Through the App Secondary · During the one month intervention

Number of participants who sent at least one text message via the app

GroupValue95% CI
App Control Condition0
App Experimental Condition1
Daily Mood and Energy Levels Secondary · Daily

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

Mood
GroupValue95% CI
App Control Condition6.91± 1.67
App Experimental Condition6.53± 1.35
Energy
GroupValue95% CI
App Control Condition5.58± 1.35
App Experimental Condition5.80± 1.61
Self-Reported Vigorous Physical Activity Secondary · Baseline and one month from the start of the intervention

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).

Pre-test
GroupValue95% CI
App Control Condition1.94± 1.83
App Experimental Condition2.13± 1.83
Post-test
GroupValue95% CI
App Control Condition2.77± 1.63
App Experimental Condition2.53± 1.83
Self-Reported Moderate Physical Activity Secondary · Baseline and one month from the start of the intervention

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).

Pre-Test
GroupValue95% CI
App Control Condition3.94± 1.44
App Experimental Condition3.50± 1.67
Post-test
GroupValue95% CI
App Control Condition4.13± 1.18
App Experimental Condition3.63± 1.76
Self-Reported Light Physical Activity Secondary · Baseline and one month from the start of the intervention

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).

Pre-test
GroupValue95% CI
App Control Condition4.77± 0.56
App Experimental Condition4.69± 0.64
Post-test
GroupValue95% CI
App Control Condition4.61± 0.84
App Experimental Condition4.78± 0.61

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Walking and Daily Affect Among Sedentary Older Adults Measured Using the StepMATE App: Pilot Randomized Controlled Trial.
    Bisson AN, Sorrentino V, Lachman ME. · · 2021 · cited 6× · PMID 34855609 · DOI 10.2196/27208

Verify or expand the search:

Other recruiting trials for Sedentary Lifestyle

Currently open trials in the same condition.

Other Brandeis University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03124537.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing