MoST-Influenced Behavioral Intervention for Walking
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
2 other identifiers
interventional
606
1 country
1
Brief Summary
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, thought to engage one key behavioral mechanism of action (MoA) for improving daily walking by at least 1000 steps per day in persons who have been objectively verified as sedentary and are at risk for cardiovascular disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cardiovascular-diseases
Started Sep 2022
Typical duration for phase_2 cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Start
First participant enrolled
September 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2026
CompletedFebruary 27, 2026
February 1, 2026
3.3 years
June 8, 2022
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Longitudinally Measured Self-Efficacy
Self-efficacy, the hypothesized mechanism of action, will be assessed using the Self-Efficacy for Walking - Duration (SEW-DUR) 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.
Self-efficacy will be assessed every two weeks during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods.
Change in Longitudinally Measured Physical Activity due to Self-Efficacy.
Participant steps will be assessed continuously using a Fitbit activity tracking 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.
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.
Secondary Outcomes (2)
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.
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.
Other Outcomes (5)
Participant Satisfaction with the BCT Intervention
Satisfaction will be assessed monthly during the intervention (8 weeks in duration).
Participant Satisfaction with the Trial Components
Satisfaction will be assessed at the completion of the follow-up period (24 weeks from baseline).
Participant Adherence to BCT Intervention Arm.
Assessed once after the completion of the intervention (12 weeks from baseline).
- +2 more other outcomes
Study Arms (16)
Goal Setting and Action Planning and Self-Monitoring and Feedback
EXPERIMENTALParticipants 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.
Goal Setting and Action Planning and Feedback
EXPERIMENTALParticipants 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.
Goal Setting and Self-Monitoring and Feedback
EXPERIMENTALParticipants 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.
Goal Setting and Action Planning, and Self-Monitoring
EXPERIMENTALParticipants 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.
Action Planning and Self-Monitoring, and Feedback
EXPERIMENTALParticipants 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.
Goal Setting and Action Planning
EXPERIMENTALParticipants 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.
Goal Setting and Self-Monitoring
EXPERIMENTALParticipants 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.
Goal Setting and Feedback
EXPERIMENTALParticipants 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.
Action Planning and Self-Monitoring
EXPERIMENTALParticipants 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.
Action Planning and Feedback
EXPERIMENTALParticipants 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.
Self-Monitoring and Feedback
EXPERIMENTALParticipants 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.
Goal Setting
EXPERIMENTALParticipants 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.
Action Planning
EXPERIMENTALParticipants 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.
Self-Monitoring
EXPERIMENTALParticipants 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.
Feedback
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONParticipants 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."
Interventions
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?".
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?"
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."
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. "
Eligibility Criteria
You may qualify if:
- Age 18 - 74 years old of age
- Self-reported physical inactivity
- Objectively determined to be sedentary in baseline
- Possess at least one risk factor for CVD
- 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
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Columbia Universitycollaborator
Study Sites (1)
Institute of Health System Science
New York, New York, 10022, United States
Related Publications (1)
Goodwin AM, Gordon S, Sahni R, Vicari F, Accardi K, Crusco S, Duer-Hefele J, Friel C, Suls J, Cheung YK, Vrany EA, Davidson KW. Influencing basic behavioral mechanisms of action while targeting daily walking in sedentary adults at risk for cardiovascular disease: randomised factorial design protocol. BMJ Open. 2025 Jan 4;15(1):e080307. doi: 10.1136/bmjopen-2023-080307.
PMID: 39755564DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karina W Davidson, PhD, MASc
Northwell Health
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 21, 2022
Study Start
September 12, 2022
Primary Completion
January 12, 2026
Study Completion
January 13, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De- identified, pooled individual participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
- Access Criteria
- All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.
All collected IPD will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)