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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

Must not have

Previously diagnosed with a heart attack, stroke, peripheral vascular disease, or received a stent

< 18 years old or > 74 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up satisfaction will be assessed monthly during the intervention (8 weeks in duration).

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am between 18 and 74 years old.

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I am mostly inactive in my daily life.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a heart attack, stroke, peripheral vascular disease, or received a stent.

Select...

I am younger than 18 or older than 74.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ satisfaction will be assessed monthly during the intervention (8 weeks in duration).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Longitudinally Measured Physical Activity due to Self-Efficacy.

Change in Longitudinally Measured Self-Efficacy

Secondary study objectives

Change in Longitudinally Measured Physical Activity due to the BCT Intervention

Indirect Effect of the BCT Intervention on Physical Activity

Other study objectives

Mean Fitbit Device Adherence Rate.

Mean Participant Survey Adherence Rate.

Participant Adherence to BCT Intervention Arm.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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