Clinical trial NCT05425641: MoST-Influenced Behavioral Intervention for Walking
Official title: Influencing Basic Behavioral Mechanisms of Action While Targeting Daily Walking in Those at Risk for Cardiovascular Disease: Science of Behavior Change Factorial Experiment of Behavioral Change
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cardiovascular Diseases
Physical Inactivity
Keywords: Sedentary Behavior
Physical Activity
Behavior Change
Behavior Change Techniques
Virtual
Cardiovascular Health
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Columbia University
First posted: 2022-06-21
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Longitudinally Measured Self-Efficacy
timeFrame: Self-efficacy will be assessed every two weeks during the baseline (4 weeks), intervention (8 weeks), and follow-up (12 weeks) periods.
measure: Change in Longitudinally Measured Physical Activity due to Self-Efficacy.
timeFrame: 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.
Secondary outcomes:
measure: Change in Longitudinally Measured Physical Activity due to the BCT Intervention
timeFrame: 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.
measure: Indirect Effect of the BCT Intervention on Physical Activity
timeFrame: 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.
Other outcomes:
measure: Participant Satisfaction with the BCT Intervention
timeFrame: Satisfaction will be assessed monthly during the intervention (8 weeks in duration).
measure: Participant Satisfaction with the Trial Components
timeFrame: Satisfaction will be assessed at the completion of the follow-up period (24 weeks from baseline).
measure: Participant Adherence to BCT Intervention Arm.
timeFrame: Assessed once after the completion of the intervention (12 weeks from baseline).
measure: Mean Participant Survey Adherence Rate.
timeFrame: Assessed once after completion of the trial (24 weeks from baseline).
measure: Mean Fitbit Device Adherence Rate.
timeFrame: Assessed once after completion of the trial (24 weeks from baseline).
Locations:
city: New York
country: United States
facility: Institute of Health System Science
state: New York
Study officials:
affiliation: Northwell Health
name: Karina W Davidson, PhD, MASc
role: PRINCIPAL_INVESTIGATOR
References: