MoST-Influenced Behavioral Intervention for Walking
- Conditions
- Physical InactivityCardiovascular Diseases
- Interventions
- Behavioral: Goal SettingBehavioral: Action PlanningBehavioral: Self-Monitoring of BehaviorBehavioral: Feedback on Behavior
- Registration Number
- NCT05425641
- Lead Sponsor
- Northwell Health
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 624
- 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
- < 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Goal Setting and Action Planning and Self-Monitoring and Feedback Feedback on Behavior 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. Goal Setting and Action Planning and Feedback Action Planning 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. Goal Setting and Action Planning and Self-Monitoring and Feedback Action Planning 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. Goal Setting and Action Planning and Self-Monitoring and Feedback Self-Monitoring of Behavior 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. Action Planning and Self-Monitoring, and Feedback Action Planning 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. Goal Setting and Self-Monitoring Self-Monitoring of Behavior 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. Goal Setting and Action Planning and Feedback Goal Setting 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. Goal Setting and Action Planning and Feedback Feedback on Behavior 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. Goal Setting and Self-Monitoring and Feedback Goal Setting 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. Goal Setting and Self-Monitoring and Feedback Feedback on Behavior 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. Goal Setting and Action Planning, and Self-Monitoring Goal Setting 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. Goal Setting and Action Planning, and Self-Monitoring Action Planning 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. Action Planning and Self-Monitoring, and Feedback Self-Monitoring of Behavior 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. Goal Setting and Action Planning and Self-Monitoring and Feedback Goal Setting 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. Goal Setting and Self-Monitoring and Feedback Self-Monitoring of Behavior 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. Goal Setting and Action Planning Goal Setting 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. Action Planning and Self-Monitoring Self-Monitoring of Behavior 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. Goal Setting Goal Setting 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. Self-Monitoring Self-Monitoring of Behavior 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. Feedback Feedback on Behavior 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. Goal Setting and Action Planning, and Self-Monitoring Self-Monitoring of Behavior 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. Action Planning Action Planning 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. Action Planning and Self-Monitoring, and Feedback Feedback on Behavior 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. Goal Setting and Action Planning Action Planning 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. Action Planning and Self-Monitoring Action Planning 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. Action Planning and Feedback Action Planning 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. Action Planning and Feedback Feedback on Behavior 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. Goal Setting and Self-Monitoring Goal Setting 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. Self-Monitoring and Feedback Self-Monitoring of Behavior 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. Goal Setting and Feedback Goal Setting 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. Goal Setting and Feedback Feedback on Behavior 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. Self-Monitoring and Feedback Feedback on Behavior 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.
- Primary Outcome Measures
Name Time Method Change in Longitudinally Measured Self-Efficacy Self-efficacy will be assessed every two weeks during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods. 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.
Change in Longitudinally Measured Physical Activity due to Self-Efficacy. 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. 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.
- Secondary Outcome Measures
Name Time Method 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. 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.
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. 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.
Trial Locations
- Locations (1)
Institute of Health System Science
🇺🇸New York, New York, United States