Trial Outcomes & Findings for Daily Activity Study of Health: Increasing Physical Activity in Aging (NCT NCT04315363)
NCT ID: NCT04315363
Last Updated: 2024-02-29
Results Overview
This metric quantifies the change in the average amount of time spent sedentary each day in hours, from the baseline period to the 6-week follow-up period. It is a marker of time spent inactive.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline; 6-week
Results posted on
2024-02-29
Participant Flow
Participant milestones
| Measure |
Intervention
Brain MRI and Motivational Behavioral Intervention
Behavioral Intervention: Motivational messaging (self affirmation on highest ranked value and positively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional
|
Active Control
Brain MRI and Control Behavioral Intervention
Control Behavioral Intervention: Control motivational messaging (self affirmation on lowest ranked value and negatively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daily Activity Study of Health: Increasing Physical Activity in Aging
Baseline characteristics by cohort
| Measure |
Intervention
n=21 Participants
Brain MRI and Motivational Behavioral Intervention
Behavioral Intervention: Motivational messaging (self affirmation on highest ranked value and positively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional
|
Active Control
n=19 Participants
Brain MRI and Control Behavioral Intervention
Control Behavioral Intervention: Control motivational messaging (self affirmation on lowest ranked value and negatively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 5.4 • n=93 Participants
|
68.4 years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
68.7 years
STANDARD_DEVIATION 5.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
12 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
19 participants
n=4 Participants
|
40 participants
n=27 Participants
|
|
education
|
16.6 years
STANDARD_DEVIATION 3.6 • n=93 Participants
|
16.0 years
STANDARD_DEVIATION 3.6 • n=4 Participants
|
16.3 years
STANDARD_DEVIATION 3.5 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline; 6-weekPopulation: The number of average daily hours spent sedentary after the intervention compared to the pre-intervention baseline.
This metric quantifies the change in the average amount of time spent sedentary each day in hours, from the baseline period to the 6-week follow-up period. It is a marker of time spent inactive.
Outcome measures
| Measure |
Intervention
n=21 Participants
Brain MRI and Motivational Behavioral Intervention
Behavioral Intervention: Motivational messaging (self affirmation on highest ranked value and positively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional
|
Active Control
n=17 Participants
Brain MRI and Control Behavioral Intervention
Control Behavioral Intervention: Control motivational messaging (self affirmation on lowest ranked value and negatively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional
|
|---|---|---|
|
Change in Sedentary Behavior (Average Hour/Day)
|
-0.11 Change in average daily hours
Standard Deviation 1.62
|
0.05 Change in average daily hours
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Baseline; 6-weekPopulation: The change in average number of daily minutes spent in moderate-to-vigorous physical activity after the intervention compared to the pre-intervention baseline.
This measure focuses on the change in average moderate-to-vigorous physical activity (MVPA) daily minutes after the intervention compared to the pre-intervention average MVPA baseline.
Outcome measures
| Measure |
Intervention
n=21 Participants
Brain MRI and Motivational Behavioral Intervention
Behavioral Intervention: Motivational messaging (self affirmation on highest ranked value and positively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional
|
Active Control
n=19 Participants
Brain MRI and Control Behavioral Intervention
Control Behavioral Intervention: Control motivational messaging (self affirmation on lowest ranked value and negatively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional
|
|---|---|---|
|
Change in Moderate-to-Vigorous Physical Activity
|
-0.17 Change in minutes daily
Standard Deviation 1.09
|
0.14 Change in minutes daily
Standard Deviation 0.41
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place