Trial Outcomes & Findings for A Trial of Habit Formation Theory for Exercise in Older Adults (NCT NCT04869644)
NCT ID: NCT04869644
Last Updated: 2022-11-30
Results Overview
Automaticity of behavior is assessed by a 4-item questionnaire asking about the automaticity of participant's walking behavior using a 4-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree". Items are summed together to form a total score ranging from 0 to 12, with higher scores indicating that participant's new walking behaviors have become more habitual and automatic. Change in daily automaticity levels over the course of the intervention period will be examined until scores level out and reach a score of 8 or more on 7 consecutive days. Participants will be judged to have reached an asymptote at this point in time. The proportion of the sample that has achieved automaticity will be reported as a number with percentage \[N(%)\]. Time-to-event analyses will be conducting examining participant differences in reaching an asymptote for automaticity and overall time-to-event will represented using Kaplan-Meier curves.
COMPLETED
PHASE1
49 participants
Assessed daily via online survey for participants across the duration of the 10-week intervention. Daily assessments will be aggregated by week to generate weekly means for automaticity.
2022-11-30
Participant Flow
Prior to beginning the intervention, participants completed a 2-week baseline period. Data were collected for the overall BCT intervention, not for individual BCT messages. All BCTs were delivered simultaneously as a multi-BCT package.
Participant milestones
| Measure |
Intervention: Behavioral Change Techniques to Encourage Habit Formation
Participants in Group 1 received BCT messages 5 days a week for a 10-week intervention period with the following BCTs: goal setting, action planning, self-monitoring of behavior, behavioral rehearsal, rehearsal conducted in a consistent context
|
|---|---|
|
Assessed for Eligibility
STARTED
|
114
|
|
Assessed for Eligibility
Did Not Meet or Complete Inclusion Criteria
|
35
|
|
Assessed for Eligibility
Did Not Consent to Study
|
30
|
|
Assessed for Eligibility
COMPLETED
|
49
|
|
Assessed for Eligibility
NOT COMPLETED
|
65
|
|
Enrolled in Study
STARTED
|
49
|
|
Enrolled in Study
Withdrew From Study
|
5
|
|
Enrolled in Study
COMPLETED
|
44
|
|
Enrolled in Study
NOT COMPLETED
|
5
|
|
Baseline
STARTED
|
44
|
|
Baseline
Ineligible After Baseline
|
8
|
|
Baseline
Withdrew From Study
|
2
|
|
Baseline
COMPLETED
|
34
|
|
Baseline
NOT COMPLETED
|
10
|
|
Intervention
STARTED
|
34
|
|
Intervention
Discontinued Intervention
|
2
|
|
Intervention
COMPLETED
|
32
|
|
Intervention
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Habit Formation Theory for Exercise in Older Adults
Baseline characteristics by cohort
| Measure |
Intervention: Behavioral Change Techniques to Encourage Habit Formation
n=44 Participants
Participants in Group 1 received BCT messages 5 days a week for a 10-week intervention period with the following BCTs: goal setting, action planning, self-monitoring of behavior, behavioral rehearsal, rehearsal conducted in a consistent context
|
|---|---|
|
Age, Customized
45 to 55
|
12 Participants
n=5 Participants
|
|
Age, Customized
46 to 65
|
26 Participants
n=5 Participants
|
|
Age, Customized
66 to 75
|
6 Participants
n=5 Participants
|
|
Age, Customized
Over 75
|
0 Participants
n=5 Participants
|
|
Age, Customized
Declined to Respond
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 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
|
3 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed daily via online survey for participants across the duration of the 10-week intervention. Daily assessments will be aggregated by week to generate weekly means for automaticity.Population: Participants who completed the baseline eligibility period continued on to the intervention. All participants in the intervention period received the daily automaticity survey for the 10-week intervention period.
Automaticity of behavior is assessed by a 4-item questionnaire asking about the automaticity of participant's walking behavior using a 4-point Likert scale with responses ranging from "Strongly Disagree" to "Strongly Agree". Items are summed together to form a total score ranging from 0 to 12, with higher scores indicating that participant's new walking behaviors have become more habitual and automatic. Change in daily automaticity levels over the course of the intervention period will be examined until scores level out and reach a score of 8 or more on 7 consecutive days. Participants will be judged to have reached an asymptote at this point in time. The proportion of the sample that has achieved automaticity will be reported as a number with percentage \[N(%)\]. Time-to-event analyses will be conducting examining participant differences in reaching an asymptote for automaticity and overall time-to-event will represented using Kaplan-Meier curves.
Outcome measures
| Measure |
Intervention: Behavioral Change Techniques to Encourage Habit Formation
n=34 Participants
Participants in Group 1 received BCT messages 5 days a week for a 10-week intervention period with the following BCTs: goal setting, action planning, self-monitoring of behavior, behavioral rehearsal, rehearsal conducted in a consistent context
|
|---|---|
|
Change in Automaticity Score.
|
17 Participants
|
PRIMARY outcome
Timeframe: Assessed once after completion of the study at 12 weeks.Participants will rate their satisfaction with the Personalized Trial overall and with individual elements of the trial in a satisfaction survey developed for this trial. Participants will rate 9 items assessing satisfaction with methods and process of the trial on a 4-point Likert scale with responses ranging from "0 - Not at all satisfied" to "3 - Very satisfied". Higher scores indicate greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction.
Outcome measures
| Measure |
Intervention: Behavioral Change Techniques to Encourage Habit Formation
n=32 Participants
Participants in Group 1 received BCT messages 5 days a week for a 10-week intervention period with the following BCTs: goal setting, action planning, self-monitoring of behavior, behavioral rehearsal, rehearsal conducted in a consistent context
|
|---|---|
|
Participant Satisfaction With Personalized Trial Components.
"Please rate your overall satisfaction with the BCT text messages"
|
2.53 Score for Participant Satisfaction Item
Standard Deviation 0.78
|
|
Participant Satisfaction With Personalized Trial Components.
"Please rate your satisfaction with the ease of using the BCT text messages"
|
2.97 Score for Participant Satisfaction Item
Standard Deviation 0.18
|
|
Participant Satisfaction With Personalized Trial Components.
"Please rate your satisfaction with the overall effectiveness of the BCT text messages"
|
2.50 Score for Participant Satisfaction Item
Standard Deviation 0.82
|
|
Participant Satisfaction With Personalized Trial Components.
"Video explanations and demonstrations of study devices and procedures"
|
2.38 Score for Participant Satisfaction Item
Standard Deviation 0.67
|
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Participant Satisfaction With Personalized Trial Components.
"Text messaging for reminders (e.g. synch your Fitbit)"
|
2.76 Score for Participant Satisfaction Item
Standard Deviation 0.54
|
|
Participant Satisfaction With Personalized Trial Components.
"Text messaging for data collection (i.e. surveys)"
|
2.65 Score for Participant Satisfaction Item
Standard Deviation 0.67
|
|
Participant Satisfaction With Personalized Trial Components.
"Use of the Fitbit device to track your activity and sleep"
|
2.60 Score for Participant Satisfaction Item
Standard Deviation 0.60
|
|
Participant Satisfaction With Personalized Trial Components.
"Study communications"
|
2.67 Score for Participant Satisfaction Item
Standard Deviation 0.58
|
|
Participant Satisfaction With Personalized Trial Components.
"Presentation of your results"
|
2.38 Score for Participant Satisfaction Item
Standard Deviation 0.92
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SECONDARY outcome
Timeframe: Steps will be assessed continuously via worn activity tracker and step counts will be reported daily.Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by baseline and intervention phases to generate average daily steps in each phase. Changes in daily steps between baseline and intervention phases will be compared using Generalized Linear Mixed Model analyses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed once after completion of the study at 12 weeks.This is assessed using a single yes/no item assessed daily asking participants "Did you walk according to your walking plan today?". For each participant, we will identify the proportion of days during the 10-week intervention where the participant adhered to the walking plan. Proportions of adherence will reported across all participants with means and standard deviations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed once after the completion of the intervention period.Participants will be asked via survey about their attitudes and opinions regarding the personalized trial implementation (e.g., Did the trial feel burdensome?). Participants will rate items on a 7-point Likert scale with responses ranging from "0 - Strongly Disagree" to "6 - Strongly Agree". Higher scores indicate greater levels of agreement. Scores on each item will be reported with means and standard deviations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed daily via online survey for participants across the duration of the 10 week intervention. Daily responses will be aggregated across the intervention to determine an overall proportion of days adherent self-monitoring of behavior.This will be measured via a single survey item delivered following a participant's scheduled walking time asking them to record the number of steps they took on their walk. Individuals who complete this item and record their steps will be judged to be adherent to self-monitoring of their walking behavior. Participant adherence will be aggregated over the course of the 10-week intervention and will be reported as proportion of days adherent to self-monitoring. Proportions of adherence will be reported across all participants with means and standard deviations.
Outcome measures
Outcome data not reported
Adverse Events
Intervention: Behavioral Change Techniques to Encourage Habit Formation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention: Behavioral Change Techniques to Encourage Habit Formation
n=44 participants at risk
Participants in Group 1 received BCT messages 5 days a week for a 10-week intervention period with the following BCTs: goal setting, action planning, self-monitoring of behavior, behavioral rehearsal, rehearsal conducted in a consistent context
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|---|---|
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Product Issues
Rash
|
4.5%
2/44 • Number of events 2 • Data for adverse events were collected for each participant over 12 weeks (2-week baseline and 10-week intervention).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place