Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)
Condition: Physical Activity
Study type: Interventional

Summary: 
      Community based interventions are more acceptable to community members when all participants
      receive the intervention. A 'stepped-wedge' or 'multiple-baseline' design allows for all
      participants to receive the intervention by randomizing participants into conditions defined
      by the length of the baseline period. The primary aim of this pilot study is to gather data
      that will allow the researchers to estimate parameters, such as the appropriate length of the
      baseline period that will allow them to power a larger study. A second key aim is to
      determine if a smartphone intervention that is delivered to parents can increase physical
      activity in their 6-10 year old inactive children.
    

Detailed description: 
      Low levels of physical activity in childhood are related to obesity and risk for diabetes and
      cardiovascular disease. This translational study is an attempt to take interventions that
      have been shown to be effective in highly controlled setting and implement them in the
      community. We will utilize a form of a single case design (i.e., stepped-wedge or
      multiple-baseline design), which is an underused, though promising, alternative to the
      traditional, parallel-group randomized trial in which each study participant acts as his/her
      own control. Participants will be randomized to baseline periods of varying length such that
      the change in the study outcome can be causally attributed to introduction of the
      intervention. In accordance, families will be randomized to a 2, 4, or 6-week baseline period
      before being administered the P-Mobile app based intervention. All families will receive the
      same P-Mobile intervention following the baseline period. The P-Mobile intervention will be
      delivered to parents via the P-Mobile smartphone app; it consists of 10 lessons designed to
      increase physical activity in children. The parents will also receive notifications designed
      to prompt physical activity, motivate, and remind parents of lesson content. The intervention
      will also utilize an adaptive step goal approach, in which the step goal is modified based on
      each participant's individual performance. The primary aims of the study are: (1) To estimate
      several parameters, which will allow us to redesign our study as a single case design (and to
      conduct simulation-based power calculations): (a) average day-to-day variability in daily
      steps during the baseline period, (b) average autocorrelation in the daily step data, and (c)
      average effect size at 2 weeks, 4 weeks, and 6 weeks after introduction of the intervention.
      (2) To test the feasibility of the P-Mobile app (3) To demonstrate our ability to recruit
      participants from targeted neighborhoods.
    

Intervention name(s): P-Mobile App
Intervention type(s): Behavioral
Intervention description(s): The behavioral strategies are based on Social Cognitive Theory. The following topics will be covered: self-monitoring, goal setting, stimulus control, making time for exercise, exercising in- and outdoors, problem-solving, reinforcing PA, reducing sedentary behaviors, relapse prevention, parental modeling, lifestyle exercise, self-efficacy, self-management, parental PA modeling, parental co-participation, and establishing PA rules. Parents will be provided with adapted step goals (based on principles of shaping). Text messages will be designed to prompt PA, remind parents of concepts from the lessons, and motivate behavioral change.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: In accordance with a single case design approach, where each subject acts as his/her own control, families will be randomized to a 2, 4, or 6-week baseline period before being administered the P-Mobile app based intervention. All families will receive the same P-Mobile intervention following the baseline period.
Masking: None (Open Label)
Primary purpose: Other
Keywords: single-case design; children; health equity; mobile health