MoST-Influenced Behavioral Intervention for Walking

Sponsor

Northwell Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05425641

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Columbia University (Other)

624

Enrollment

Location

Arms

Anticipated Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Physical Inactivity	Behavioral: Goal Setting Behavioral: Action Planning Behavioral: Self-Monitoring of Behavior Behavioral: Feedback on Behavior	Phase 2

Detailed Description

This study is a randomized, factorial experiment using the basic Science of Behavior Change (SOBC) approach to efficiently test the effects of four distinct behavior change techniques (BCTs), goal setting, action planning, self- monitoring and feedback, hypothesized to engage one key behavioral mechanism of action (MoA-self-efficacy for walking) for improving daily walking by at least 1000 steps per day in persons who have been objectively verified as sedentary (average <5,000 steps per day) and are at risk for cardiovascular disease. Participants who self-report themselves as physically sedentary and possess cardiovascular risk factors are eligible for a 4-week baseline period in which they must demonstrate adherence to Fitbit activity tracking use, completion of survey measures, and be objectively verified as sedentary (average <5,000 steps per day). Participants who successfully complete baseline will proceed to the 8-week intervention phase of the study. They will be randomized to one of 16 possible intervention arms and receive one or more behavior change techniques shown to be efficacious in promoting greater physical activity. Behavior change techniques will be delivered via text message each morning with the goal of increasing low intensity walking by 1,000 steps more than the baseline step average. One group (control) will not receive any BCT messages. Upon completion of the intervention phase, participants will continue to have their step counts continuously monitored during the 12-week follow-up phase. All participants will complete bi-weekly surveys throughout the entire duration of the study (baseline, intervention, follow-up).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

624 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

The study uses a factorial design to randomize participants to all combinations of 4 behavior change techniques (BCTs). There will also be a control group which will receive no BCT intervention.The study uses a factorial design to randomize participants to all combinations of 4 behavior change techniques (BCTs). There will also be a control group which will receive no BCT intervention.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Influencing Basic Behavioral Mechanisms of Action While Targeting Daily Walking in Those at Risk for Cardiovascular Disease: Science of Behavior Change Factorial Experiment of Behavioral Change

Anticipated Study Start Date :

Jul 31, 2022

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Change in Longitudinally Measured Self-Efficacy [Self-efficacy will be assessed every two weeks during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods.]
Self-efficacy, the hypothesized mechanism of action, 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 capabilities/self-efficacy. The effect of the BCT intervention on longitudinal self-efficacy for physical activity will be assessed using linear mixed effects models, which include a random participant effect, fixed BCT intervention effects, a fixed time effect, and fixed BCT-time interaction. Potential moderators (including participant age, gender, and baseline physical activity) will also be examined.
Change in Longitudinally Measured Physical Activity due to Self-Efficacy. [Steps will be assessed continuously via worn activity tracker. Step counts will be aggregated and analyzed at the daily level during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods.]
Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by baseline, intervention, and follow-up phases to generate average daily steps in each phase. Associations between self-efficacy and physical activity will be assessed using linear mixed effects models, which include a random participant effect, fixed self-efficacy intervention effects, a fixed time effect, and fixed self-efficacy-time interaction. Potential moderators (including participant age, gender, and baseline physical activity) will also be examined.

Secondary Outcome Measures

Change in Longitudinally Measured Physical Activity due to the BCT Intervention [Steps will be assessed continuously via worn activity tracker. Step counts will be aggregated and analyzed at the daily level during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods.]
Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by baseline, intervention, and follow-up phases to generate average daily steps in each phase. The effect of the BCT intervention on physical activity will be assessed using linear mixed effects models, which include a random participant effect, fixed BCT intervention effects, a fixed time effect, and fixed BCT-time interaction. Potential moderators (including participant age, gender, and baseline physical activity) will also be examined.
Indirect Effect of the BCT Intervention on Physical Activity [Steps will be assessed continuously via worn activity tracker. Step counts will be aggregated and analyzed at the daily level during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods.]
Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by baseline, intervention, and follow-up phases to generate average daily steps in each phase. The effects of the BCT intervention on physical activity via the hypothesized mechanism of action, self-efficacy, will be examined using natural effects models for effect decomposition into direct effect and indirect effect mediated by increase in self-efficacy relative to baseline. In addition, in order to assess how the timing of increase in self-efficacy mediates BCT effects, we will perform sequential mediation analysis en bloc under the natural effects modeling framework.

Other Outcome Measures

Participant Satisfaction with the BCT Intervention [Satisfaction will be assessed monthly during the intervention (8 weeks in duration).]
Participants will rate their satisfaction with the BCTs they receive in monthly survey measures. Participants will rate their satisfaction with the BCTs on a scale of 1 to 4 with higher numbers indicating greater levels of satisfaction. Means and standard deviations will be reported for BCT satisfaction.
Participant Satisfaction with the Trial Components [Satisfaction will be assessed at the completion of the follow-up period (24 weeks from baseline).]
Participants will rate their satisfaction with the trial overall and with individual elements of the trial in a satisfaction survey administered at the end of the follow-up period. Satisfaction items are not part of an already existing scale but were developed to assess participant satisfaction with specific elements of the current study and the trial overall. Participants will rate their satisfaction on a scale of 1 to 5, with higher numbers indicating greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction.
Participant Adherence to BCT Intervention Arm. [Assessed once after the completion of the intervention (12 weeks from baseline).]
For each daily delivered BCT intervention, participant adherence will be tracked using text message responses or confirmation of viewing the BCT. This information will determine rates of adherence to the BCT intervention. Rates of adherence for the BCT intervention across all participants will be reported with means and standard deviations.
Mean Participant Survey Adherence Rate. [Assessed once after completion of the trial (24 weeks from baseline).]
For each participant, the proportion of surveys measures completed will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Mean Fitbit Device Adherence Rate. [Assessed once after completion of the trial (24 weeks from baseline).]
For each participant, the proportion of days where the Fitbit device was worn will be calculated. Completion rates across all participants will be reported with means and standard deviations.
Mean Participant Fitbit Sleep Rate. [Assessed once after completion of the trial (24 weeks from baseline).]
For each participant, the average days of participant-observed sleep data, defined as recorded sleep and wake cycles, will be calculated across all participants with means and standard deviations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18 - 74 years old of age
Self-reported physical inactivity
Objectively determined to be sedentary in baseline
Possess risk factors for CVD
Community-dwelling
Report they are in good general health and have never been informed by a clinician that it was not advisable/safe to participate in a low-intensity walking program
Owns and can regularly access a smartphone capable of receiving text messages
Owns and can regularly access an e-mail account

Exclusion Criteria:

< 18 years old or > 74 years old
Have self-reported poor health, limited mobility and/or have been advised by a clinician not to increase their low-intensity walking
Previously diagnosed with a heart attack, stroke, peripheral vascular disease, or received a stent
Inability to comply with study protocol during 4 week baseline period
Pregnancy
Previous diagnosis of a serious mental health condition or psychiatric disorder, such as bipolar disorder or schizophrenia
Cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Health System Science	New York	New York	United States	10022

Sponsors and Collaborators

Northwell Health
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University

Investigators

Principal Investigator: Karina W Davidson, PhD, MASc, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Northwell Health

ClinicalTrials.gov Identifier:

NCT05425641

Other Study ID Numbers:

21- 0467
R01HL153810

First Posted:

Jun 21, 2022

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Northwell Health

Sedentary Behavior

Physical Activity

Behavior Change

Behavior Change Techniques

Virtual

Cardiovascular Health

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Aug 9, 2022

Arm	Intervention/Treatment
Experimental: Goal Setting and Action Planning and Self-Monitoring and Feedback Participants in this arm will receive daily text messages that include the Goal Setting, Action Planning, Self-Monitoring, and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Goal Setting Individuals will receive daily text messages that include the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Goal Setting BCT is "Is your goal to walk an extra 1,000 steps more than your baseline average?". Behavioral: Action Planning Individuals will receive daily text messages that include the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Action Planning BCT is "Take one minute and plan for today how, where and when you can walk an extra 1,000 steps more than your baseline average. Have you planned for today?" Behavioral: Self-Monitoring of Behavior Individuals will receive daily text messages that include the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Self-Monitoring BCT is "Check your fitbit for yesterday. Type in the number of steps you did yesterday." Behavioral: Feedback on Behavior Individuals will receive daily text messages that include the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Feedback BCT is "Your goal is to walk 1000 steps more than your baseline average. Yesterday you did not meet your goal. If you think this is incorrect you can check your step count from yesterday on your Fitbit app to confirm. "
Experimental: Goal Setting and Action Planning and Feedback Participants in this arm will receive daily text messages that include the Goal Setting, Action Planning, and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Goal Setting Individuals will receive daily text messages that include the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Goal Setting BCT is "Is your goal to walk an extra 1,000 steps more than your baseline average?". Behavioral: Action Planning Individuals will receive daily text messages that include the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Action Planning BCT is "Take one minute and plan for today how, where and when you can walk an extra 1,000 steps more than your baseline average. Have you planned for today?" Behavioral: Feedback on Behavior Individuals will receive daily text messages that include the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Feedback BCT is "Your goal is to walk 1000 steps more than your baseline average. Yesterday you did not meet your goal. If you think this is incorrect you can check your step count from yesterday on your Fitbit app to confirm. "
Experimental: Goal Setting and Self-Monitoring and Feedback Participants in this arm will receive daily text messages that include the Goal Setting, Self-Monitoring, and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Goal Setting Individuals will receive daily text messages that include the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Goal Setting BCT is "Is your goal to walk an extra 1,000 steps more than your baseline average?". Behavioral: Self-Monitoring of Behavior Individuals will receive daily text messages that include the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Self-Monitoring BCT is "Check your fitbit for yesterday. Type in the number of steps you did yesterday." Behavioral: Feedback on Behavior Individuals will receive daily text messages that include the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Feedback BCT is "Your goal is to walk 1000 steps more than your baseline average. Yesterday you did not meet your goal. If you think this is incorrect you can check your step count from yesterday on your Fitbit app to confirm. "
Experimental: Goal Setting and Action Planning, and Self-Monitoring Participants in this arm will receive daily text messages that include the Goal Setting, Action Planning, and Self-Monitoring behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Goal Setting Individuals will receive daily text messages that include the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Goal Setting BCT is "Is your goal to walk an extra 1,000 steps more than your baseline average?". Behavioral: Action Planning Individuals will receive daily text messages that include the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Action Planning BCT is "Take one minute and plan for today how, where and when you can walk an extra 1,000 steps more than your baseline average. Have you planned for today?" Behavioral: Self-Monitoring of Behavior Individuals will receive daily text messages that include the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Self-Monitoring BCT is "Check your fitbit for yesterday. Type in the number of steps you did yesterday."
Experimental: Action Planning and Self-Monitoring, and Feedback Participants in this arm will receive daily text messages that include the Action Planning, Self-Monitoring, and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Action Planning Individuals will receive daily text messages that include the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Action Planning BCT is "Take one minute and plan for today how, where and when you can walk an extra 1,000 steps more than your baseline average. Have you planned for today?" Behavioral: Self-Monitoring of Behavior Individuals will receive daily text messages that include the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Self-Monitoring BCT is "Check your fitbit for yesterday. Type in the number of steps you did yesterday." Behavioral: Feedback on Behavior Individuals will receive daily text messages that include the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Feedback BCT is "Your goal is to walk 1000 steps more than your baseline average. Yesterday you did not meet your goal. If you think this is incorrect you can check your step count from yesterday on your Fitbit app to confirm. "
Experimental: Goal Setting and Action Planning Participants in this arm will receive daily text messages that include the Goal Setting and Action Planning behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Goal Setting Individuals will receive daily text messages that include the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Goal Setting BCT is "Is your goal to walk an extra 1,000 steps more than your baseline average?". Behavioral: Action Planning Individuals will receive daily text messages that include the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Action Planning BCT is "Take one minute and plan for today how, where and when you can walk an extra 1,000 steps more than your baseline average. Have you planned for today?"
Experimental: Goal Setting and Self-Monitoring Participants in this arm will receive daily text messages that include the Goal Setting and Self-Monitoring behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Goal Setting Individuals will receive daily text messages that include the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Goal Setting BCT is "Is your goal to walk an extra 1,000 steps more than your baseline average?". Behavioral: Self-Monitoring of Behavior Individuals will receive daily text messages that include the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Self-Monitoring BCT is "Check your fitbit for yesterday. Type in the number of steps you did yesterday."
Experimental: Goal Setting and Feedback Participants in this arm will receive daily text messages that include the Goal Setting and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Goal Setting Individuals will receive daily text messages that include the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Goal Setting BCT is "Is your goal to walk an extra 1,000 steps more than your baseline average?". Behavioral: Feedback on Behavior Individuals will receive daily text messages that include the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Feedback BCT is "Your goal is to walk 1000 steps more than your baseline average. Yesterday you did not meet your goal. If you think this is incorrect you can check your step count from yesterday on your Fitbit app to confirm. "
Experimental: Action Planning and Self-Monitoring Participants in this arm will receive daily text messages that include the Action Planning and Self-Monitoring behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Action Planning Individuals will receive daily text messages that include the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Action Planning BCT is "Take one minute and plan for today how, where and when you can walk an extra 1,000 steps more than your baseline average. Have you planned for today?" Behavioral: Self-Monitoring of Behavior Individuals will receive daily text messages that include the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Self-Monitoring BCT is "Check your fitbit for yesterday. Type in the number of steps you did yesterday."
Experimental: Action Planning and Feedback Participants in this arm will receive daily text messages that include the Action Planning and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Action Planning Individuals will receive daily text messages that include the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Action Planning BCT is "Take one minute and plan for today how, where and when you can walk an extra 1,000 steps more than your baseline average. Have you planned for today?" Behavioral: Feedback on Behavior Individuals will receive daily text messages that include the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Feedback BCT is "Your goal is to walk 1000 steps more than your baseline average. Yesterday you did not meet your goal. If you think this is incorrect you can check your step count from yesterday on your Fitbit app to confirm. "
Experimental: Self-Monitoring and Feedback Participants in this arm will receive daily text messages that include the Self-Monitoring and Feedback behavior change techniques (BCTs) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Self-Monitoring of Behavior Individuals will receive daily text messages that include the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Self-Monitoring BCT is "Check your fitbit for yesterday. Type in the number of steps you did yesterday." Behavioral: Feedback on Behavior Individuals will receive daily text messages that include the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Feedback BCT is "Your goal is to walk 1000 steps more than your baseline average. Yesterday you did not meet your goal. If you think this is incorrect you can check your step count from yesterday on your Fitbit app to confirm. "
Experimental: Goal Setting Participants in this arm will receive daily text messages with the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Goal Setting Individuals will receive daily text messages that include the Goal Setting behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Goal Setting BCT is "Is your goal to walk an extra 1,000 steps more than your baseline average?".
Experimental: Action Planning Participants in this arm will receive daily text messages with the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Action Planning Individuals will receive daily text messages that include the Action Planning behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Action Planning BCT is "Take one minute and plan for today how, where and when you can walk an extra 1,000 steps more than your baseline average. Have you planned for today?"
Experimental: Self-Monitoring Participants in this arm will receive daily text messages with the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Self-Monitoring of Behavior Individuals will receive daily text messages that include the Self-Monitoring behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Self-Monitoring BCT is "Check your fitbit for yesterday. Type in the number of steps you did yesterday."
Experimental: Feedback Participants in this arm will receive daily text messages with the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count.	Behavioral: Feedback on Behavior Individuals will receive daily text messages that include the Feedback behavior change technique (BCT) with the goal of increasing daily walking by 1,000 more steps than their baseline average step count. An example of the Feedback BCT is "Your goal is to walk 1000 steps more than your baseline average. Yesterday you did not meet your goal. If you think this is incorrect you can check your step count from yesterday on your Fitbit app to confirm. "
No Intervention: Control Participants in this arm will not receive any daily BCT text messages. Instead, individuals receive daily text messages with the text "Please acknowledge that you have received this text message."