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Behavioral Intervention for Increasing Walking in Cardiovascular Disease Risk

Phase 2
Recruiting
Led By Karina W Davidson, PhD, MASc
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 - 74 years old
Objectively determined to be sedentary in baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up satisfaction will be assessed monthly during the intervention (8 weeks in duration).
Awards & highlights

Study Summary

This trial is testing four different techniques to see if they can get people to walk more. The techniques are: goal setting, action planning, self-monitoring and feedback, and thought. They want to see if these techniques can help people at risk for cardiovascular disease to walk more.

Who is the study for?
This trial is for adults aged 18-74 who are sedentary, generally healthy, at risk for cardiovascular disease (CVD), and have not been advised against low-intensity walking. Participants must own a smartphone and email account. Excluded are those with poor health, mobility issues, serious heart conditions, cognitive impairments or major mental health diagnoses.Check my eligibility
What is being tested?
The study tests four behavior change techniques: goal setting, action planning, self-monitoring of behavior, and feedback on behavior to increase daily walking by at least 1000 steps in sedentary individuals at risk for CVD. It's a randomized experiment that assigns participants to different combinations of these techniques.See study design
What are the potential side effects?
Since the interventions involve non-invasive behavioral strategies like setting goals and receiving feedback rather than medical treatments or drugs, there are no direct side effects associated with this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 74 years old.
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I am mostly inactive in my daily life.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~satisfaction will be assessed monthly during the intervention (8 weeks in duration).
This trial's timeline: 3 weeks for screening, Varies for treatment, and satisfaction will be assessed monthly during the intervention (8 weeks in duration). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Longitudinally Measured Physical Activity due to Self-Efficacy.
Change in Longitudinally Measured Self-Efficacy
Secondary outcome measures
Change in Longitudinally Measured Physical Activity due to the BCT Intervention
Indirect Effect of the BCT Intervention on Physical Activity
Other outcome measures
Mean Fitbit Device Adherence Rate.
Mean Participant Survey Adherence Rate.
Participant Adherence to BCT Intervention Arm.
+2 more

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: Self-Monitoring and FeedbackExperimental Treatment2 Interventions
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.
Group II: Self-MonitoringExperimental Treatment1 Intervention
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.
Group III: Goal Setting and Self-Monitoring and FeedbackExperimental Treatment3 Interventions
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.
Group IV: Goal Setting and Self-MonitoringExperimental Treatment2 Interventions
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.
Group V: Goal Setting and FeedbackExperimental Treatment2 Interventions
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.
Group VI: Goal Setting and Action Planning, and Self-MonitoringExperimental Treatment3 Interventions
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.
Group VII: Goal Setting and Action Planning and Self-Monitoring and FeedbackExperimental Treatment4 Interventions
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.
Group VIII: Goal Setting and Action Planning and FeedbackExperimental Treatment3 Interventions
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.
Group IX: Goal Setting and Action PlanningExperimental Treatment2 Interventions
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.
Group X: Goal SettingExperimental Treatment1 Intervention
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.
Group XI: FeedbackExperimental Treatment1 Intervention
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.
Group XII: Action Planning and Self-Monitoring, and FeedbackExperimental Treatment3 Interventions
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.
Group XIII: Action Planning and Self-MonitoringExperimental Treatment2 Interventions
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.
Group XIV: Action Planning and FeedbackExperimental Treatment2 Interventions
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.
Group XV: Action PlanningExperimental Treatment1 Intervention
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.
Group XVI: ControlActive Control1 Intervention
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."
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goal Setting
2017
N/A
~200
Action Planning
2021
Completed Phase 1
~280

Find a Location

Who is running the clinical trial?

Columbia UniversityOTHER
1,431 Previous Clinical Trials
2,460,209 Total Patients Enrolled
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,309 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,308,872 Total Patients Enrolled

Media Library

Action Planning Clinical Trial Eligibility Overview. Trial Name: NCT05425641 — Phase 2
Cardiovascular Disease Clinical Trial 2023: Action Planning Highlights & Side Effects. Trial Name: NCT05425641 — Phase 2
Action Planning 2023 Treatment Timeline for Medical Study. Trial Name: NCT05425641 — Phase 2
Cardiovascular Disease Research Study Groups: Action Planning, Goal Setting, Self-Monitoring, Goal Setting and Action Planning, Goal Setting and Self-Monitoring, Goal Setting and Feedback, Self-Monitoring and Feedback, Goal Setting and Action Planning and Self-Monitoring and Feedback, Goal Setting and Action Planning and Feedback, Goal Setting and Action Planning, and Self-Monitoring, Action Planning and Self-Monitoring, and Feedback, Action Planning and Self-Monitoring, Action Planning and Feedback, Feedback, Control, Goal Setting and Self-Monitoring and Feedback

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged eighty or over being accepted for the trial?

"The demographics of this research study include adults aged 18-74."

Answered by AI

To what degree can Self-Monitoring of Behavior be detrimental to people?

"Self-Monitoring of Behavior's safety is thought to be moderately safe, as it has been evaluated in a Phase 2 trial; although there is evidence that supports its security, data demonstrating efficacy remains absent."

Answered by AI

Is this research initiative open to new participants?

"Per the information available on clinicaltrials.gov, this medical trial is recruiting participants right now. The study was first published on September 12th 2022 and modified most recently two days later."

Answered by AI

What kind of individuals are eligible to participate in this clinical experiment?

"This clinical trial seeks 624 patients with cardiovascular illnesses, aged between 18 and 74. Applicants must be self-reporting physical inactivity, sedentary at baseline tests, have CVD risk factors, not informed by a doctor that it is unsafe to partake in low-intensity walking programs, own a smartphone for receiving text messages and an email account."

Answered by AI

How many participants have enrolled in this medical research project?

"Affirmative. Clinicaltrials.gov declares that this research, initially posted on September 12th 2022, is actively enrolling participants. 624 individuals need to be recruited from 1 site for the trial's completion."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
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MoST-Influenced Behavioral Intervention for Walking
2022. "MoST-Influenced Behavioral Intervention for Walking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05425641.
~361 spots leftby Jun 2026
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