Cardiovascular Diseases, Physical Inactivity
Conditions
Keywords
Sedentary Behavior, Physical Activity, Behavior Change, Behavior Change Techniques, Virtual, Cardiovascular 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).
Interventions
BEHAVIORALGoal Setting
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?".
BEHAVIORALAction Planning
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?"
BEHAVIORALSelf-Monitoring of Behavior
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."
BEHAVIORALFeedback on Behavior
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. "
Sponsors
Northwell Health
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKarina W Davidson, PhD, MASc
Northwell Health
Outcome results
None listed