Physical ActivityPre-PLACENCT03087123
Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)
A study testing P-Mobile App in people with Physical Activity, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- P-Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- Significant cardiovascular disease or disorders via self-report
- Other significant medical problems that would prevent them from engaging in regular physical activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- P-Mobile App
- Keywords
- single-case design, children, health equity, mobile health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-Mobile AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 2-Week Baseline | Active comparator | 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. Receives: Behavioral: P-Mobile App |
| 4-Week Baseline | Active comparator | 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. Receives: Behavioral: P-Mobile App |
| 6-Week Baseline | Active comparator | 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. Receives: Behavioral: P-Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline.
Secondary outcomes (6)
Height
Height will be measured using a standard stadiometer and will be measured to the nearest 0.1 kg
Measured: Baseline, Week 4, 8, and 12.
Weight
Weight will be measured using a balance beam scale without shoes and will be recorded to the nearest 0.1 cm.
Measured: Baseline, Week 4, 8, and 12.
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).
Measured: Baseline, Week 4, 8, and 12.
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.
Measured: Baseline, Week 4, 8, and 12.
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.
Measured: Baseline, Week 4, 8, and 12.
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Apr 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Broyles, Pennington Biomedical Research Center
- Investigators
- Stephanie Broyles, Ph.D., Principal investigator, Pennington Biomedical Research CenterRobert L. Newton, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087123
- Sponsor's protocol ID
- PBRC 2016-068
- Acronym
- Pre-PLACE
- Status last verified
- Sep 2022
- First submitted
- 15 Mar 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)
- ClinicalTrials.gov ID
- NCT03087123
- Acronym / sponsor ID
- Pre-PLACE / PBRC 2016-068
- Conditions
- Physical Activity
- Keywords
- single-case design, children, health equity, mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 2-Week Baseline | Active comparator | Behavioral: P-Mobile AppFamilies 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. |
| 4-Week Baseline | Active comparator | Behavioral: P-Mobile AppFamilies 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. |
| 6-Week Baseline | Active comparator | Behavioral: P-Mobile AppFamilies 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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).
- Have a smartphone
Key exclusion criteria (2 listed)
- Significant cardiovascular disease or disorders via self-report
- Other significant medical problems that would prevent them from engaging in regular physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-Mobile AppThe 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. | Behavioural | 2-Week Baseline, 4-Week Baseline, 6-Week Baseline |
Primary outcome
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.
6 secondary outcomes
Height
Time frame: Baseline, Week 4, 8, and 12.
Weight
Time frame: Baseline, Week 4, 8, and 12.
Body composition
Time frame: Baseline, Week 4, 8, and 12.
Home and neighborhood environment questionnaire
Time frame: Baseline, Week 4, 8, and 12.
Sibling Relationship Inventory (SRI).
Time frame: Baseline, Week 4, 8, and 12.
Treatment satisfaction
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Broyles, Ph.D. principal investigator
Pennington Biomedical Research Center
Robert L. Newton, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-Mobile App in people with Physical Activity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.