Trial Outcomes & Findings for Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults (NCT NCT04967313)

Last Updated: 2023-02-01

Results Overview

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. Changes in daily steps between intervention and baseline will be represented using a regression parameter.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

Steps will be assessed continuously via worn activity tracker. Step counts will be aggregated and analyzed at the daily level. This will yield 70 daily measurements of physical activity over the course of the 10-week study.

Results posted on

2023-02-01

Participant Flow

Participants were consented and entered a 2-week baseline period prior to beginning the intervention. Participants who were not compliant with trial requirements during baseline did not continue to receive the intervention. Data were collected for the overall BCT intervention and not for each individual BCT.

Participant milestones

Participant milestones
Measure	Behavioral Change Techniques to Increase Walking Individuals will receive daily text messages with the goal of increasing daily walking by 2,000 more steps five days per week. Participants will be enrolled for a baseline period lasting two weeks where their average daily activity level will be assessed using a Fitbit device to generate an average daily step counts. Following completion of baseline, participants will receive daily text messages of behavior change techniques (BCTs) for eight weeks. The four BCTs utilized in this study are: goal setting, action planning, self-monitoring of behavior, and feedback on behavior. Each BCT will be delivered to participants daily for a two-week block. Four blocks (one BCT per block) will be delivered to the participant. The order in which the BCT interventions are presented to participants will be randomized by the study statistician. The goal of the BCT text messages will be to encourage walking behavior. Behavioral Change Techniques: Four behavioral changes techniques (BCTs) will be administered to participants in random order.
Baseline STARTED	72
Baseline Ineligible After Baseline	11
Baseline Did Not Sign Addendum	1
Baseline COMPLETED	60
Baseline NOT COMPLETED	12
Intervention STARTED	60
Intervention COMPLETED	59
Intervention NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Change Techniques to Increase Walking n=60 Participants Individuals will receive daily text messages with the goal of increasing daily walking by 2,000 more steps five days per week. Participants will be enrolled for a baseline period lasting two weeks where their average daily activity level will be assessed using a Fitbit device to generate an average daily step counts. Following completion of baseline, participants will receive daily text messages of behavior change techniques (BCTs) for eight weeks. The four BCTs utilized in this study are: goal setting, action planning, self-monitoring of behavior, and feedback on behavior. Each BCT will be delivered to participants daily for a two-week block. Four blocks (one BCT per block) will be delivered to the participant. The order in which the BCT interventions are presented to participants will be randomized by the study statistician. The goal of the BCT text messages will be to encourage walking behavior. Behavioral Change Techniques: Four behavioral changes techniques (BCTs) will be administered to participants in random order.
Age, Customized 45 to 55	31 Participants n=39 Participants
Age, Customized 56 to 65	27 Participants n=39 Participants
Age, Customized 66 to 75	2 Participants n=39 Participants
Age, Customized Decline to Respond	0 Participants n=39 Participants
Sex: Female, Male Female	55 Participants n=39 Participants
Sex: Female, Male Male	5 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=39 Participants
Race (NIH/OMB) Asian	4 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	5 Participants n=39 Participants
Race (NIH/OMB) White	48 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=39 Participants

PRIMARY outcome

Timeframe: Steps will be assessed continuously via worn activity tracker. Step counts will be aggregated and analyzed at the daily level. This will yield 70 daily measurements of physical activity over the course of the 10-week study.

Population: GLMM Regression for Change in Daily Steps Due to BCT Intervention

Outcome measures

Outcome measures
Measure	Behavioral Change Techniques to Increase Walking n=60 Participants Individuals will receive daily text messages with the goal of increasing daily walking by 2,000 more steps five days per week. Following completion of baseline, participants will receive daily text messages of behavior change techniques (BCTs) for eight weeks. The four BCTs utilized in this study are: goal setting, action planning, self-monitoring of behavior, and feedback on behavior.
Within-person Change in Daily Steps. Increase in Daily Steps Due to Intervention	120.85 Daily Steps
Within-person Change in Daily Steps. Standard Error for Regression of Intervention on Daily Steps	257.42 Daily Steps

PRIMARY outcome

Timeframe: Assessed once after completion of the study at 10 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

Outcome measures
Measure	Behavioral Change Techniques to Increase Walking n=59 Participants Individuals will receive daily text messages with the goal of increasing daily walking by 2,000 more steps five days per week. Following completion of baseline, participants will receive daily text messages of behavior change techniques (BCTs) for eight weeks. The four BCTs utilized in this study are: goal setting, action planning, self-monitoring of behavior, and feedback on behavior.
Participant Satisfaction With Personalized Trial Components. The behavior change techniques (BCTs) assigned to you	2.10 Score on a scale Standard Deviation 0.92
Participant Satisfaction With Personalized Trial Components. The frequency that each BCT was delivered to you (daily)	2.38 Score on a scale Standard Deviation 0.81
Participant Satisfaction With Personalized Trial Components. Video explanations and demonstrations of study devices and procedures	2.06 Score on a scale Standard Deviation 1.00
Participant Satisfaction With Personalized Trial Components. Text messaging for delivery of study interventions (BCTs)	2.42 Score on a scale Standard Deviation 0.84
Participant Satisfaction With Personalized Trial Components. Text messaging for reminders (e.g. sync your Fitbit)	2.59 Score on a scale Standard Deviation 0.73
Participant Satisfaction With Personalized Trial Components. Text messaging for data collection (i.e. surveys)	2.60 Score on a scale Standard Deviation 0.70
Participant Satisfaction With Personalized Trial Components. Use of the fitbit device to track your activity and sleep	2.71 Score on a scale Standard Deviation 0.56
Participant Satisfaction With Personalized Trial Components. Study communications	2.52 Score on a scale Standard Deviation 0.73
Participant Satisfaction With Personalized Trial Components. Presentation of your results	2.37 Score on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Assessed at baseline, week 2, week 4, week 6, week 8, and week 10.

This will be assessed using the Self-Efficacy for Walking (SE-W) scale,\[1\] an 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 capabilities/self-efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed once after completion of the study at 10 weeks.

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

Adverse Events

Behavioral Change Techniques to Increase Walking

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

Joan Duer-Hefele, RN, MA

Northwell Health

Phone: 646-766-7153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place