Trial Outcomes & Findings for Random Assignment of Intervention Messages for Developing Personalized Decision Rules to Promote Physical Activity (NCT NCT03907683)

Last Updated: 2022-11-04

Results Overview

Fitbit-assessed minutes with step counts \>= 100 steps/min in 15-minute epochs (steady states represent the change in expected step counts if a message was delivered versus if the message was not delivered)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

82 participants

Primary outcome timeframe

15-minute epochs for the remainder of the walking day

Results posted on

2022-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Random Messaging Participants receive 0-6 messages/day from the Random AIM app. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages are selected randomly from three content domains: Move More (40%), Sit Less (40%), and Inspirational Quotes Unrelated to Movement (20%). Half of the messages are accompanied by images. Message selection and timing are determined randomly each night for the following day. Short Message with Text and Optional Image: Messages can be up to 256 characters of text and with or without an image. "Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).
Overall Study STARTED	82
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Random Messaging Participants receive 0-6 messages/day from the Random AIM app. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages are selected randomly from three content domains: Move More (40%), Sit Less (40%), and Inspirational Quotes Unrelated to Movement (20%). Half of the messages are accompanied by images. Message selection and timing are determined randomly each night for the following day. Short Message with Text and Optional Image: Messages can be up to 256 characters of text and with or without an image. "Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).
Overall Study Pregnancy	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Random Assignment of Intervention Messages for Developing Personalized Decision Rules to Promote Physical Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Random Messaging n=82 Participants Participants receive 0-6 messages/day from the Random AIM app. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages are selected randomly from three content domains: Move More (40%), Sit Less (40%), and Inspirational Quotes Unrelated to Movement (20%). Half of the messages are accompanied by images. Message selection and timing are determined randomly each night for the following day. Short Message with Text and Optional Image: Messages can be up to 256 characters of text and with or without an image. "Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23.7 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	19 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants

PRIMARY outcome

Timeframe: 15-minute epochs for the remainder of the walking day

Outcome measures

Outcome measures
Measure	Random Messaging n=80 Participants Participants receive 0-6 messages/day from the Random AIM app. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages are selected randomly from three content domains: Move More (40%), Sit Less (40%), and Inspirational Quotes Unrelated to Movement (20%). Half of the messages are accompanied by images. Message selection and timing are determined randomly each night for the following day. Short Message with Text and Optional Image: Messages can be up to 256 characters of text and with or without an image. "Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).
Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt Weekday Move More Messages (person-specific steady state estimate)	0.16 minutes Standard Deviation 0.69
Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt Weekday Sit Less Messages (person-specific steady state estimate)	0.13 minutes Standard Deviation 0.69
Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt Weekday Inspirational Quote Messages (person-specific steady state estimate)	0.25 minutes Standard Deviation 1.23
Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt Weekend Move More Messages (person-specific steady state estimate)	0.31 minutes Standard Deviation 1.44
Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt Weekend Sit Less Messages (person-specific steady state estimate)	0.28 minutes Standard Deviation 0.95
Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt Weekend Inspirational Quote Messages (person-specific steady state estimate)	0.11 minutes Standard Deviation 1.51

Adverse Events

Random Messaging

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

Dr David E Conroy

The Pennsylvania State University

Phone: 814-863-3451

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place