Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)

Physical Activity Clinical Trial

— Pre-PLACE  

Official title:

Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087123
• Other study ID #: PBRC 2016-068
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: September 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• P-Mobile App
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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Fitbit®: The child will wear a wireless activity monitor (Fitbit®) for the entire study. The Charge 2 wrist-worn Fitbit will be utilized.	Baseline.
Secondary	Height	Height will be measured using a standard stadiometer and will be measured to the nearest 0.1 kg	Baseline, Week 4, 8, and 12.
Secondary	Weight	Weight will be measured using a balance beam scale without shoes and will be recorded to the nearest 0.1 cm.	Baseline, Week 4, 8, and 12.
Secondary	Body composition	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).	Baseline, Week 4, 8, and 12.
Secondary	Home and neighborhood environment questionnaire	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.	Baseline, Week 4, 8, and 12.
Secondary	Sibling Relationship Inventory (SRI).	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.	Baseline, Week 4, 8, and 12.
Secondary	Treatment satisfaction	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.	Week 12