Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Physical activity
时间窗: Baseline.
Fitbit®: The child will wear a wireless activity monitor (Fitbit®) for the entire study. The Charge 2 wrist-worn Fitbit will be utilized.
次要结局
- Height(Baseline, Week 4, 8, and 12.)
- Home and neighborhood environment questionnaire(Baseline, Week 4, 8, and 12.)
- Body composition(Baseline, Week 4, 8, and 12.)
- Weight(Baseline, Week 4, 8, and 12.)
- Sibling Relationship Inventory (SRI).(Baseline, Week 4, 8, and 12.)
- Treatment satisfaction(Week 12)
研究者
Stephanie Broyles
Associate Professor
Pennington Biomedical Research Center
