Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 6 - 10 |
| Updated: | 4/17/2018 |
| Start Date: | April 1, 2017 |
| End Date: | June 2019 |
| Contact: | Chelsea A. Hendrick |
| Email: | chelsea.hendrick@pbrc.edu |
| Phone: | 225-763-2918 |
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.
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.
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.
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.
Inclusion Criteria:
The child must:
- Be 6-10 years of age
- Have at least one participating parent.
- Be Physically capable of exercise
- Have an average steps/day less than the 50th percentile for age and gender (e.g.,
<8,900 steps/day for 10-year old girls and <10,200 steps/day for 10-year old boys).
The parent must:
- Have a smartphone
- Be willing to download and use the P-Mobile app
- Demonstrate the ability to send text messages
- Have no plans to move during the study period (up to 4 months)
Families must:
•Reside in targeted geographic area
Exclusion Criteria:
Exclusion criteria for the child includes:
- Significant cardiovascular disease or disorders via self-report
- Other significant medical problems that would prevent them from engaging in regular
physical activity.
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