Trial Outcomes & Findings for A BCT Intervention for Physical Activity Among Individuals on Statins (NCT NCT05273723)

Last Updated: 2024-12-31

Results Overview

Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by run-in and follow-up periods to generate average daily steps in each period. Average daily steps in the follow-up period will be compared to average daily steps in the run-in period. If the average steps in follow-up are 2,000 steps per day greater than during run-in, the outcome for the Time-to-Event Continual Reassessment Method (TiTE-CRM) will be judged successful. The minimum effective dose (MED) will be defined as the smallest BCT dose duration associated with 80% participants receiving that dose having a successful increase in walking between the run-in and the follow-up periods. Pre-specified to report primary and secondary outcome results across the full sample.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

42 participants

Primary outcome timeframe

Mean daily step totals will be compared between the run-in (2 weeks pre-intervention) and follow-up periods (2 weeks post-variable intervention of 5-10 weeks).

Results posted on

2024-12-31

Participant Flow

The first two weeks of the study are a baseline assessment period. Participants will be mailed a commercially available Fitbit to wear day and night, and eCAP bottle to fill using their existing statin prescription. After successful completion of the baseline period, participants will move on to the intervention period.

Participant milestones

Participant milestones
Measure	Multi-BCT Intervention 5 Weeks 5-week multi-component BCT intervention delivered via text messages	Multi-BCT Intervention 6 Weeks 6-week multi-component BCT intervention delivered via text messages	Multi-BCT Intervention 8 Weeks 8-week multi-component BCT intervention delivered via text messages	Multi-BCT Intervention 9 Weeks 9-week multi-component BCT intervention delivered via text messages	Multi-BCT Intervention 10 Weeks 10-week multi-component BCT intervention delivered via text messages
Cohort 1: 5 Week Intervention STARTED	3	0	0	0	0
Cohort 1: 5 Week Intervention COMPLETED	3	0	0	0	0
Cohort 1: 5 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 2: 6 Week Intervention STARTED	0	3	0	0	0
Cohort 2: 6 Week Intervention COMPLETED	0	3	0	0	0
Cohort 2: 6 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 3: 8 Week Intervention STARTED	0	0	3	0	0
Cohort 3: 8 Week Intervention COMPLETED	0	0	3	0	0
Cohort 3: 8 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 4: 8 Week Intervention STARTED	0	0	2	0	0
Cohort 4: 8 Week Intervention COMPLETED	0	0	2	0	0
Cohort 4: 8 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 5: 9 Week Intervention STARTED	0	0	0	3	0
Cohort 5: 9 Week Intervention COMPLETED	0	0	0	3	0
Cohort 5: 9 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 6: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 6: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 6: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 7: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 7: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 7: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 8: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 8: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 8: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 9: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 9: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 9: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 10: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 10: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 10: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 11: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 11: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 11: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 12: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 12: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 12: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 13: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 13: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 13: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 14: 10 Week Intervention STARTED	0	0	0	0	3
Cohort 14: 10 Week Intervention COMPLETED	0	0	0	0	3
Cohort 14: 10 Week Intervention NOT COMPLETED	0	0	0	0	0
Cohort 15: 10 Week Intervention STARTED	0	0	0	0	1
Cohort 15: 10 Week Intervention COMPLETED	0	0	0	0	1
Cohort 15: 10 Week Intervention NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A BCT Intervention for Physical Activity Among Individuals on Statins

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention (All Participants) n=42 Participants Dose-finding study with 13 groups of 3 participants each, 1 group of 2 participants, and 1 group of 1 participant. To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 1 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report results across the full sample.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 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	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Mean daily step totals will be compared between the run-in (2 weeks pre-intervention) and follow-up periods (2 weeks post-variable intervention of 5-10 weeks).

Population: Results presented for the full sample. This is an adaptive trial using the TiTE-CRM. Doses are assigned using adaptive methods throughout the trial using all available data from all participants, regardless of enrollment cohort or dose assignment. As a result, there are no a priori hypotheses for comparing outcomes between dose levels. Of the 42 participants who received the intervention, 40 participants (95.2%) had sufficient data to generate estimates of the MED.

Outcome measures

Outcome measures
Measure	Intervention (All Participants) n=40 Participants To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 5 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report primary and secondary outcome results across the full sample.
Number of Participants Who Achieved a 2,000 Step/Day Increase Between run-in and Follow-up	7 Participants

SECONDARY outcome

Timeframe: Mean daily step totals will be compared between the run-in (2 weeks pre-intervention) and follow-up periods (2 weeks post-variable intervention of 5-10 weeks).

Population: Results presented for the full sample. This is an adaptive trial using the TiTE-CRM. Doses are assigned using adaptive methods throughout the trial using all available data from all participants, regardless of enrollment cohort or dose assignment. As a result, there are no a priori hypotheses for comparing outcomes between dose levels. Of the 42 participants who received the intervention, n=32 (76.2%) had sufficient data during the baseline and follow-up periods to include in analyses.

Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by run-in and follow-up periods to generate average daily steps in each period. Changes in daily steps between run-in and intervention periods will be compared using Generalized Linear Mixed Model Analyses. Pre-specified to report primary and secondary outcome results across the full sample.

Outcome measures

Outcome measures
Measure	Intervention (All Participants) n=32 Participants To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 5 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report primary and secondary outcome results across the full sample.
Within-person Change in Daily Steps.	-152.23 steps/day Standard Deviation 2,596.99

SECONDARY outcome

Timeframe: Self-efficacy will be assessed at the completion of the 2-week run-in and at the end of the 2-week follow-up period. Changes in self-efficacy will be reported comparing mean difference scores between run-in and follow-up (follow-up mean minus run-in mean)

Population: Results presented for the full sample. This is an adaptive trial using the TiTE-CRM. Doses are assigned using adaptive methods throughout the trial using all available data from all participants, regardless of enrollment cohort or dose assignment. As a result, there are no a priori hypotheses for comparing outcomes between dose levels. Of the 42 participants who completed the intervention, n=30 (71.4%) had enough survey data to include in analyses.

Self-efficacy will be assessed using the Self-Efficacy for Walking (SE-W) scale, a 10-item measure assessing patient's capabilities to walk for durations of 5 to 50 minutes. Items are scored from 0 to 100%, with scores of 0% indicating participants are "not at all confident" they could walk for that duration and scores of 100% indicating the participants are "highly confident" they could walk that duration. Items are average to create a total score, with higher scores indicating higher levels of beliefs about self-efficacy. Pre-specified to report primary and secondary outcome results across the full sample.

Outcome measures

Outcome measures
Measure	Intervention (All Participants) n=30 Participants To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 5 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report primary and secondary outcome results across the full sample.
Within-person Change in Self-Efficacy for Walking.	18.87 score on a scale Standard Deviation 22.49

SECONDARY outcome

Timeframe: Intrinsic regulation (IR) will be assessed at the completion of the 2-week run-in and end of the 2-week follow-up period. Changes in IR will be reported comparing mean difference scores between run-in and follow-up (follow-up mean minus run-in mean)

Population: Results presented for the full sample. This is an adaptive trial using the TiTE-CRM. Doses are assigned using adaptive methods throughout the trial using all available data from all participants, regardless of enrollment cohort or dose assignment. As a result, there are no a priori hypotheses for comparing outcomes between dose levels. Of the 42 participants who completed the intervention, n=30 (71.4%) had enough survey data to include in analyses.

This will be assessed using a 4-item measure assessing intrinsic regulation, a subscale of the Behavioral Regulations in Exercise Questionnaire Version 2 (BREQ-2). Items are scored on a 0 (Not true for me) to 4 (Very true for me) scale, and averaged to create a total score, with higher scores indicating greater intrinsic regulation. Pre-specified to report primary and secondary outcome results across the full sample.

Outcome measures

Outcome measures
Measure	Intervention (All Participants) n=30 Participants To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 5 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report primary and secondary outcome results across the full sample.
Within-person Change in Intrinsic Regulation.	0.292 score on a scale Standard Deviation 0.905

SECONDARY outcome

Timeframe: Discrepancy in behavior (DIB) will be assessed at the completion of the 2-week run-in and end of the 2-week follow-up period. Changes in DIB will be reported comparing mean difference scores between run-in and follow-up (follow-up mean minus run-in mean)

Population: Results presented for the full sample. This is an adaptive trial using the TiTE-CRM. Doses are assigned using adaptive methods throughout the trial using all available data from all participants, regardless of enrollment cohort or dose assignment. As a result, there are no a priori hypotheses for comparing outcomes between dose levels. Of the 42 participants who completed the intervention, n=30 (71.4%) had enough survey data to include in analyses.

This will be assessed with a single item measuring discrepancy in behavior. The text of the measure is "How large is the difference between your current walking behavior and your goal concerning your walking?" The question is rated from 1 (Not at all different) to 7 (very different) with higher scores indicating greater levels of discrepancy in behavior. Pre-specified to report primary and secondary outcome results across the full sample.

Outcome measures

Outcome measures
Measure	Intervention (All Participants) n=30 Participants To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 5 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report primary and secondary outcome results across the full sample.
Within-person Change in Discrepancy in Behavior.	-1.13 score on a scale Standard Deviation 1.36

SECONDARY outcome

Timeframe: Motivation will be assessed at the completion of the 2-week run-in and at the end of the 2-week follow-up period. Changes in motivation will be reported comparing the mean difference scores between run-in and follow-up (follow-up mean minus run-in mean)

Population: Results presented for the full sample. This is an adaptive trial using the TiTE-CRM. Doses are assigned using adaptive methods throughout the trial using all available data from all participants, regardless of enrollment cohort or dose assignment. As a result, there are no a priori hypotheses for comparing outcomes between dose levels. Of the 42 participants who completed the intervention, n=30 (71.4%) had enough survey data to include in analyses.

Motivation will be assessed with a message stating "I feel motivated to walk each day." Participants will rate this item on a scale of 1 (Not true at all) to 7 (Very true) with higher scores indicating higher levels of motivation. Pre-specified to report primary and secondary outcome results across the full sample.

Outcome measures

Outcome measures
Measure	Intervention (All Participants) n=30 Participants To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 5 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report primary and secondary outcome results across the full sample.
Within-person Change in Motivation.	0.167 score on a scale Standard Deviation 1.556

SECONDARY outcome

Timeframe: Environmental context and resources (ECaR) will be assessed at completion of 2-week run-in & end of 2-week follow-up period. Changes in ECaR will be reported comparing mean difference scores between run-in & follow-up (follow-up mean minus run-in mean)

Population: Results presented for the full sample. This is an adaptive trial using the TiTE-CRM. Doses are assigned using adaptive methods throughout the trial using all available data from all participants, regardless of enrollment cohort or dose assignment. As a result, there are no a priori hypotheses for comparing outcomes between dose levels. Of the 42 participants who completed the intervention, n=30 (71.4%) had enough survey data to include in analyses.

This will be assessed using a checklist of 7 potential barriers to walking. Barriers are coded on a 1 (Not often at all) to 5 (Very often) scale, and averaged to create a total score, with higher scores indicating that the listed barriers had greater effects on walking. Pre-specified to report primary and secondary outcome results across the full sample.

Outcome measures

Outcome measures
Measure	Intervention (All Participants) n=30 Participants To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 5 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report primary and secondary outcome results across the full sample.
Within-person Change in Environmental Context and Resources.	0.176 score on a scale Standard Deviation 0.493

SECONDARY outcome

Timeframe: Medication adherence will be assessed continuously via a smart pill bottle and adherence will be calculated daily. Change over time will be examined between the 2-week run-in and the follow-up period (2 weeks post-variable intervention of 5-10 weeks).

Population: Results presented for the full sample. This is an adaptive trial using the TiTE-CRM. Doses are assigned using adaptive methods throughout the trial using all available data from all participants, regardless of enrollment cohort or dose assignment. As a result, there are no a priori hypotheses for comparing outcomes between dose levels. Missing data were treated as non-adherence. Of 42 participants who completed the intervention, all (100%) were analyzed for within-person changes in adherence.

Participant adherence to statin medication will be assessed continuously using a smart electronic pill bottle. Daily medication adherence will be recorded for each participant across the full duration of the study. Changes in medication between run-in and intervention phases will be compared using Generalized Linear Mixed Model Analyses. Adherence during run-in and follow-up periods will be reported as the proportion of days adherent (e.g. 0.786 for 11 out of 14 days adherent). Changes in adherence between run-in and follow-up will be reported as the mean change in proportion of days adherent

Outcome measures

Outcome measures
Measure	Intervention (All Participants) n=42 Participants To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 5 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants. Pre-specified to report primary and secondary outcome results across the full sample.
Within-person Change in Medication Adherence.	-0.16 proportion of medication adherence Standard Deviation 0.29

OTHER_PRE_SPECIFIED outcome

Timeframe: Steps will be assessed continuously via worn activity tracker and step counts will be reported daily. Step counts will be averaged during the 2-weeks of run-in and by 2-week blocks during the intervention and follow-up period (5-14 weeks from run-in).

Participant heterogeneity in amount of time required to reach a successful increase in daily steps (defined as an increase of 2,000 or more steps per day over a 2-week period compared to run-in) will be examined. Average step counts will be calculated for each 2-week block during the intervention and follow-up periods. Average steps per day in these blocks will be compared with the average daily steps in the run-in period. Once a successful increase has been detected, the time to achieve this treatment response will be recorded. Differences in duration to successful increases in physical activity will be examined between participants using mixed effects regression models. Pre-specified to report primary and secondary outcome results across the full sample.