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Trial record 14 of 3062 for:    Recruiting, Not yet recruiting, Available Studies | Physical

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

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ClinicalTrials.gov Identifier: NCT03087123
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Stephanie Broyles, Pennington Biomedical Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: P-Mobile App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Official Title: Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2-Week Baseline
Families will be randomized to a 2-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 intervention will consist of 10 lessons delivered over 12 weeks designed to increase physical activity in children. The lessons will be delivered weekly and are the same ones utilized in the P-Mobile pilot study. The parents will also receive notifications designed to prompt physical activity, motivate, and remind parents of lesson content.
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.

Active Comparator: 4-Week Baseline
Families will be randomized to a 4-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 intervention will consist of 10 lessons delivered over 12 weeks designed to increase physical activity in children. The lessons will be delivered weekly and are the same ones utilized in the P-Mobile pilot study. The parents will also receive notifications designed to prompt physical activity, motivate, and remind parents of lesson content.
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.

Active Comparator: 6-Week Baseline
Families will be randomized to a 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 intervention will consist of 10 lessons delivered over 12 weeks designed to increase physical activity in children. The lessons will be delivered weekly and are the same ones utilized in the P-Mobile pilot study. The parents will also receive notifications designed to prompt physical activity, motivate, and remind parents of lesson content.
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.




Primary Outcome Measures :
  1. Physical activity [ 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.


Secondary Outcome Measures :
  1. Height [ 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

  2. Weight [ 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.

  3. Body composition [ 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).

  4. Home and neighborhood environment questionnaire [ 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.

  5. Sibling Relationship Inventory (SRI). [ 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.

  6. Treatment satisfaction [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087123


Contacts
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Contact: Chelsea A. Hendrick 225-763-2918 chelsea.hendrick@pbrc.edu
Contact: Stephanie Broyles, Ph.D. 225-763-32760 stephanie.broyles@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Stephanie Broyles, Ph.D. Pennington Biomedical Research Center
Principal Investigator: Robert L. Newton, Ph.D. Pennington Biomedical Research Center

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Responsible Party: Stephanie Broyles, Associate Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03087123     History of Changes
Other Study ID Numbers: PBRC 2016-068
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie Broyles, Pennington Biomedical Research Center:
single-case design
children
health equity
mobile health