Behavior Change Techniques (BCTs) to Improve Low Intensity Physical Activity in Older Adults
Condition: Sedentary Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pilot study is to determine the feasibility of using personalized trial
      methods in a virtual research study with Northwell employees aged 45-75 years old to increase
      low-intensity walking by 2,000 steps per day/5 days per week using four behavior change
      techniques (BCTs), provided in random order, and shown to have been effective in changing
      physical activity. The study will include a two-week baseline period during which levels of
      physical activity and adherence to the trial protocol will be evaluated. Individuals meeting
      adherence criteria will be randomized to the eight-week BCT intervention.
    

Detailed description: 
      The purpose of this pilot study is to determine the feasibility of using personalized trial
      methods in a virtual research study with Northwell employees aged 45-75 years old to increase
      low-intensity walking by 2,000 steps per day/five days per week using four behavior change
      techniques (BCTs), provided in random order, and shown to have been effective in changing
      physical activity. This pilot will help determine if a personalized, virtual trial design can
      have widespread use in future research and clinical practice. The investigators will
      randomize 60 participants. Participants will complete a two-week baseline period during which
      they will be asked to wear a Fitbit device all day and night, even while they are sleeping,
      and to acknowledge receipt of a daily text message that is not an activity prompt. Baseline
      participants will be instructed to sync their Fitbit device by opening the Fitbit app on
      their phone at least every two days. After completion of the baseline period, a clinical
      research coordinator will review individual adherence to Fitbit wear and to survey responses.
      Adherence to Fitbit wear will be defined as recorded activity of greater than 10 hours a day.
      Text message adherence will be defined as responding to a given text message. Baseline
      participants that do not achieve at least 80% adherence of Fitbit wear and text
      responsiveness during the two weeks of the baseline period will be withdrawn from the study.
      Those that maintain at least 80% adherence will be randomized to one of their selected
      behavior change techniques to begin their pilot personalized trial. Participants who are
      randomized to receive intervention sequences will receive email confirmation including their
      protocol timeline. Enrollment will continue until up to 60 participants have been randomized.
      Individuals in the intervention period will receive four BCTs: goal setting, action planning,
      self-monitoring of behavior, and feedback on behavior. BCTs will be delivered individually to
      participants over the course of eight weeks in four two-week blocks. The order of BCT
      administration will be randomized by the study statistician. Participants may receive
      additional text messages to those outlined above with important reminders to sync their data
      as needed. Upon completion, participants in the personalized trials phase will receive an
      individual report that demonstrates their walking responses in relation to their selected
      BCTs. After receiving the report, clinical research coordinators will contact participants to
      respond to questions and to obtain feedback about their personalized trials experience.
    

Intervention name(s): Behavioral Change Techniques
Intervention type(s): Behavioral
Intervention description(s): Four behavioral changes techniques (BCTs) will be administered to participants in random order. The BCTs are defined as follows:
Goal setting: set or agree on a goal defined in terms of behavior to be achieved. Example: Set the goal of walking 2,000 steps more per day.
Action planning: prompt detailed planning of performance of behavior (must include a setting [walking to the mailbox], frequency, duration, and intensity. Example: Develop a plan to walk today.
Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit. Example: Did you check your Fitbit and record daily total number of steps?
Feedback on behavior: Monitor and provide informative or evaluative feedback on performance of the behavior (e.g. form, frequency, duration, intensity). Example: You walked 6,000 steps today. This is 1,000 steps above your baseline.
Intervention model: Single Group Assignment
Intervention model description: The order of administration for the 4 Behavioral Change Techniques (BCTs) will be randomized by the study statistician.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Physical Activity; Sedentary Behavior; Behavior Change; Behavior Change Techniques; Virtual; Personalized Trial; Personalized; Feasibility