Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
NCT Number: NCT03087123
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.
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Notify Me6 year–10 year
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The child must:
The parent must:
Families must:
•Reside in targeted geographic area
Exclusion criteria
Exclusion criteria
for the child includes:
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.
Time frame: Baseline.
Fitbit®: The child will wear a wireless activity monitor (Fitbit®) for the entire study. The Charge 2 wrist-worn Fitbit will be utilized.
Time frame: Baseline, Week 4, 8, and 12.
Height will be measured using a standard stadiometer and will be measured to the nearest 0.1 kg
Time frame: Baseline, Week 4, 8, and 12.
Weight will be measured using a balance beam scale without shoes and will be recorded to the nearest 0.1 cm.
Time frame: Baseline, Week 4, 8, and 12.
The Tanita Body Composition Analyzer (model TBF-310) will be used to measure body weight and impedance (a measure of body fat and lean muscle mass).
Time frame: Baseline, Week 4, 8, and 12.
Parents will report their perceptions of the neighborhood social environment, the neighborhood built and physical activity environment, and the home food and physical activity environment.
Time frame: Baseline, Week 4, 8, and 12.
Participants will be asked to complete the Sibling Relationship Inventory. The SRI is intended to evaluate the participant's relationship with the child closest in age and currently living in the participant's household.
Time frame: Week 12
This 15-item questionnaire assesses parents' satisfaction with the intervention in four domains 1) Overall Satisfaction, 2) Helpfulness, 3) Ease of Use, and 4) Perceived Change in Physical Activity.
Pennington Biomedical Research Center
Other
Acronym: Pre-PLACE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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