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Cardiovascular DiseasesPhase 2NCT05425641

MoST-Influenced Behavioral Intervention for Walking

A Phase 2 study testing Goal Setting, Action Planning and Self-Monitoring of Behavior in people with Cardiovascular Diseases and Physical Inactivity, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases, Physical Inactivity
What is being tested?
Goal Setting, Action Planning and Self-Monitoring of Behavior
Could I receive a placebo?
No, everyone receives an active treatment
How many people
606 participants
Where
1 siteUnited States
Study dates
12 Sep 2022to 13 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Institute of Health System Science

    New York, New York, 10022

Other trials in United States

About this study

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

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.

Read the 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 and are at risk for cardiovascular disease. Participants who self-report themselves as physically sedentary and possess at least one risk factor for cardiovascular disease 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. 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 physical activity by walking 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).

Being tested
Goal Setting, Action Planning, Self-Monitoring of Behavior, Feedback on Behavior
Keywords
Sedentary Behavior, Physical Activity, Behavior Change, Behavior Change Techniques, Virtual, Cardiovascular Health
Medical subject headings
Cardiovascular Diseases, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goal SettingBehavioural

    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?".

  • Action PlanningBehavioural

    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?"

  • Self-Monitoring of BehaviorBehavioural

    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."

  • Feedback on BehaviorBehavioural

    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. "

Study groups in NCT05425641
Study groupRoleWhat they receive
Goal Setting and Action Planning and Self-Monitoring and FeedbackExperimentalParticipants 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.
Receives: Behavioral: Goal Setting; Behavioral: Action Planning; Behavioral: Self-Monitoring of Behavior; Behavioral: Feedback on Behavior
Goal Setting and Action Planning and FeedbackExperimentalParticipants 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.
Receives: Behavioral: Goal Setting; Behavioral: Action Planning; Behavioral: Feedback on Behavior
Goal Setting and Self-Monitoring and FeedbackExperimentalParticipants 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.
Receives: Behavioral: Goal Setting; Behavioral: Self-Monitoring of Behavior; Behavioral: Feedback on Behavior
Goal Setting and Action Planning, and Self-MonitoringExperimentalParticipants 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.
Receives: Behavioral: Goal Setting; Behavioral: Action Planning; Behavioral: Self-Monitoring of Behavior
Action Planning and Self-Monitoring, and FeedbackExperimentalParticipants 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.
Receives: Behavioral: Action Planning; Behavioral: Self-Monitoring of Behavior; Behavioral: Feedback on Behavior
Goal Setting and Action PlanningExperimentalParticipants 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.
Receives: Behavioral: Goal Setting; Behavioral: Action Planning
Goal Setting and Self-MonitoringExperimentalParticipants 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.
Receives: Behavioral: Goal Setting; Behavioral: Self-Monitoring of Behavior
Goal Setting and FeedbackExperimentalParticipants 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.
Receives: Behavioral: Goal Setting; Behavioral: Feedback on Behavior
Action Planning and Self-MonitoringExperimentalParticipants 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.
Receives: Behavioral: Action Planning; Behavioral: Self-Monitoring of Behavior
Action Planning and FeedbackExperimentalParticipants 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.
Receives: Behavioral: Action Planning; Behavioral: Feedback on Behavior
Self-Monitoring and FeedbackExperimentalParticipants 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.
Receives: Behavioral: Self-Monitoring of Behavior; Behavioral: Feedback on Behavior
Goal SettingExperimentalParticipants 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.
Receives: Behavioral: Goal Setting
Action PlanningExperimentalParticipants 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.
Receives: Behavioral: Action Planning
Self-MonitoringExperimentalParticipants 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.
Receives: Behavioral: Self-Monitoring of Behavior
FeedbackExperimentalParticipants 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.
Receives: Behavioral: Feedback on Behavior
ControlNo 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."

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Self-efficacy will be assessed every two weeks during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods.

  2. 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.

    Measured: 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)

  1. Change in Longitudinally Measured Physical Activity due to the BCT Intervention

    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. 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.

    Measured: 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.

  2. Indirect Effect of the BCT Intervention on Physical Activity

    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. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start12 Sep 2022
  3. Primary completion12 Jan 2026
  4. Study completion13 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
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.
Masking
None (open label)
Enrolment
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425641
Sponsor's protocol ID
21- 0467
Other IDs
R01HL153810
Status last verified
Feb 2026
First submitted
8 Jun 2022
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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)

Publications

  • 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.

    PubMed 39755564

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Goal Setting, Action Planning and Self-Monitoring of Behavior in people with Cardiovascular Diseases and Physical Inactivity, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Longitudinally Measured Self-Efficacy (time frame: Self-efficacy will be assessed every two weeks during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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