Trial Outcomes & Findings for Increasing Physical Activity Among Sedentary Older Adults:What, Where, When, and With Whom (NCT NCT03124537)

NCT ID: NCT03124537

Last Updated: 2020-10-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: Daily for one month
• Results posted on: 2020-10-20

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	41	45
Overall Study COMPLETED	31	32
Overall Study NOT COMPLETED	10	13

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	3	5
Overall Study App Crash, Incomplete Data	7	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.	Total n=63 Participants Total of all reporting groups
Age, Continuous	64.71 years STANDARD_DEVIATION 6.30 • n=5 Participants	63.63 years STANDARD_DEVIATION 7.89 • n=7 Participants	64.16 years STANDARD_DEVIATION 7.12 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	32 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: Daily for one month

Population: 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.

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

Outcome measures

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.
Number of Steps Walked Week 1 Steps	5744.00 Average Daily Steps Standard Deviation 2398.89	5279.66 Average Daily Steps Standard Deviation 2445.76
Number of Steps Walked Baseline Steps	3910.37 Average Daily Steps Standard Deviation 2971.40	3477.66 Average Daily Steps Standard Deviation 1749.29
Number of Steps Walked Week 2 Steps	5317.08 Average Daily Steps Standard Deviation 2249.66	5116.88 Average Daily Steps Standard Deviation 2983.89
Number of Steps Walked Week 3 Steps	5858.90 Average Daily Steps Standard Deviation 2446.95	5197.21 Average Daily Steps Standard Deviation 2968.79
Number of Steps Walked Week 4 Steps	5155.42 Average Daily Steps Standard Deviation 2505.59	5285.26 Average Daily Steps Standard Deviation 3493.65

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.
Exercise Self-efficacy Pre-test	2.61 units on a scale Standard Deviation 0.67	2.88 units on a scale Standard Deviation 0.83
Exercise Self-efficacy Post-test	2.43 units on a scale Standard Deviation 0.83	2.54 units on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.
Exercise Control Beliefs Post-test	4.31 units on a scale Standard Deviation 0.51	4.25 units on a scale Standard Deviation 0.62
Exercise Control Beliefs Pre-test	4.39 units on a scale Standard Deviation 0.48	4.23 units on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: During the one month intervention

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

Outcome measures

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.
Social Contact Through the App	0 participants	1 participants

SECONDARY outcome

Timeframe: 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 the analyses.

Outcome measures

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.
Daily Mood and Energy Levels Energy	5.58 units on a scale Standard Deviation 1.35	5.80 units on a scale Standard Deviation 1.61
Daily Mood and Energy Levels Mood	6.91 units on a scale Standard Deviation 1.67	6.53 units on a scale Standard Deviation 1.35

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.
Self-Reported Vigorous Physical Activity Pre-test	1.94 units on a scale Standard Deviation 1.83	2.13 units on a scale Standard Deviation 1.83
Self-Reported Vigorous Physical Activity Post-test	2.77 units on a scale Standard Deviation 1.63	2.53 units on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.
Self-Reported Moderate Physical Activity Pre-Test	3.94 units on a scale Standard Deviation 1.44	3.50 units on a scale Standard Deviation 1.67
Self-Reported Moderate Physical Activity Post-test	4.13 units on a scale Standard Deviation 1.18	3.63 units on a scale Standard Deviation 1.76

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	App Control Condition n=31 Participants 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.	App Experimental Condition n=32 Participants 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.
Self-Reported Light Physical Activity Pre-test	4.77 units on a scale Standard Deviation 0.56	4.69 units on a scale Standard Deviation 0.64
Self-Reported Light Physical Activity Post-test	4.61 units on a scale Standard Deviation 0.84	4.78 units on a scale Standard Deviation 0.61

Adverse Events

App Control Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

App Experimental Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alycia Bisson

Brandeis University

Phone: 781 736 3284

Email: lifespanlab@brandeis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place