MoST-Influenced Behavioral Intervention for Walking

Northwell Health

Status and phase: Enrolling; Phase 2

Conditions: Physical Inactivity; Cardiovascular Diseases

Treatments: Behavioral: Self-Monitoring of Behavior; Behavioral: Action Planning; Behavioral: Feedback on Behavior; Behavioral: Goal Setting

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05425641

R01HL153810 (U.S. NIH Grant/Contract)

21- 0467

Details and patient eligibility

About

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.

Full 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).

Enrollment: 624 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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624 participants in 16 patient groups

Goal Setting and Action Planning and Self-Monitoring and Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback on Behavior

Behavioral: Goal Setting

Behavioral: Action Planning

Behavioral: Self-Monitoring of Behavior

Goal Setting and Action Planning and Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback on Behavior

Behavioral: Goal Setting

Behavioral: Action Planning

Goal Setting and Self-Monitoring and Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback on Behavior

Behavioral: Goal Setting

Behavioral: Self-Monitoring of Behavior

Goal Setting and Action Planning, and Self-Monitoring

Experimental group

Description:

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.

Treatment:

Behavioral: Goal Setting

Behavioral: Action Planning

Behavioral: Self-Monitoring of Behavior

Action Planning and Self-Monitoring, and Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback on Behavior

Behavioral: Action Planning

Behavioral: Self-Monitoring of Behavior

Goal Setting and Action Planning

Experimental group

Description:

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.

Treatment:

Behavioral: Goal Setting

Behavioral: Action Planning

Goal Setting and Self-Monitoring

Experimental group

Description:

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.

Treatment:

Behavioral: Goal Setting

Behavioral: Self-Monitoring of Behavior

Goal Setting and Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback on Behavior

Behavioral: Goal Setting

Action Planning and Self-Monitoring

Experimental group

Description:

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.

Treatment:

Behavioral: Action Planning

Behavioral: Self-Monitoring of Behavior

Action Planning and Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback on Behavior

Behavioral: Action Planning

Self-Monitoring and Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback on Behavior

Behavioral: Self-Monitoring of Behavior

Goal Setting

Experimental group

Description:

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.

Treatment:

Behavioral: Goal Setting

Action Planning

Experimental group

Description:

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.

Treatment:

Behavioral: Action Planning

Self-Monitoring

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Monitoring of Behavior

Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Feedback on Behavior

Control

No Intervention group

Description:

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."