Physical ActivityNCT01551108
Parent-targeted Mobile Phone Based Intervention to Increase Physical Activity in Children (P-Mobile)
A study testing Intervention: limited behavioral strategies and Intervention: advanced behavioral strategies in people with Physical Activity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study is designed to determine if parents can deliver an intervention that will help increase physical activity in their children. The parents will be given the intervention through their mobile phones. 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?
- Intervention: limited behavioral strategies and Intervention: advanced behavioral strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2013
- 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
- Parent must own a mobile phone.
- Parent must use the text (SMS)messaging service on their mobile phone.
- Parent can access the internet on their mobile phone.
Who cannot join
- Child is 6 through 10 years old.
- Child does not engage in regular physical activity.
- Chile is physically capable of exercising.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
This study is designed to determine if parents can deliver an intervention that will help increase physical activity in their children. The parents will be given the intervention through their mobile phones.
Read the detailed description
Most children engage in insufficient amounts of moderate-to-vigorous physical activity. These low levels of moderate-to-vigorous physical activity are associated with adverse health consequences including increased risk for obesity, and cardiovascular and diabetes risk factors. Therefore, there is a need for studies that can increase physical activity levels in children. Mobile phones are a way to deliver behavioral interventions. Mobile phones are portable, allow for real-time data collection, and can potentially reach large numbers of people. Text messages can also be utilized to promote behavior change. Few mobile phone based interventions have specifically targeted child physical activity.
The aims of this pilot study were to determine the feasibility and efficacy of a physical activity promotion program targeting 6-10 year old children that is delivered to parents through mobile phones.
- Conditions
- Physical Activity
- Being tested
- Intervention: limited behavioral strategies, Intervention: advanced behavioral strategies
- Keywords
- Children, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: limited behavioral strategiesBehavioural
Parents are given access to a website, formatted for a mobile phone. The website provides parents with a target steps/day goal for their child and parents are instructed to use their mobile phone to access the study website to record their child's step count each night. Parents are also sent monthly healthy nutrition tips via text message targeting the child in order to provide these families with potentially health promoting information.
Intervention: advanced behavioral strategiesBehavioural
Parents are given access to a website, formatted for a mobile phone. The website provides parents with a target steps/day goal for their child and parents are instructed to use their mobile phone to access the study website to record their child's step count each night. Parents also receive additional behavioral strategies based on the Social Cognitive Theory. The strategies are delivered through weekly articles posted on the website. Text messages are designed to prompt parents to encourage their child's physical activity, remind parents of behavioral concepts presented in the articles (article tip), and motivate parents to foster behavioral change in their child.
| Study group | Role | What they receive |
|---|---|---|
| Mobile phone intervention: minimal | Active comparator | Intervention: limited behavioral strategies Receives: Behavioral: Intervention: limited behavioral strategies |
| Mobile phone intervention: intensive | Experimental | Intervention: advanced behavioral strategies Receives: Behavioral: Intervention: advanced behavioral strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step counts
Physical activity will be measured by utilizing pedometers.
Measured: 3 Months
Secondary outcomes (1)
Waist circumference, body mass index, blood pressure
Physical measurements will be assessed by waist circumference, body mass index, height, weight, percent body fat, and blood pressure. Questionnaires will assess mood and physical activity enjoyment.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Coca-Cola Company
- Responsible party
- Principal investigator, Robert Newton, Pennington Biomedical Research Center
- Investigators
- Robert L. Newton, Jr., PhD, Principal investigator, Pennington Biomedical Research CenterTimothy Church, MD,MPH,PhD, Principal investigator, Pennington Biomedial Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551108
- Sponsor's protocol ID
- PBRC 11022
- Status last verified
- May 2016
- First submitted
- 8 Mar 2012
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Newton RL Jr, Marker AM, Allen HR, Machtmes R, Han H, Johnson WD, Schuna JM Jr, Broyles ST, Tudor-Locke C, Church TS. Parent-targeted mobile phone intervention to increase physical activity in sedentary children: randomized pilot trial. JMIR Mhealth Uhealth. 2014 Nov 10;2(4):e48. doi: 10.2196/mhealth.3420.
PubMed 25386899
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-targeted Mobile Phone Based Intervention to Increase Physical Activity in Children (P-Mobile)
- ClinicalTrials.gov ID
- NCT01551108
- Acronym / sponsor ID
- PBRC 11022
- Conditions
- Physical Activity
- Keywords
- Children, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- The Coca-Cola Company
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Mar 2012 (estimated)
- 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.
This study is designed to determine if parents can deliver an intervention that will help increase physical activity in their children. The parents will be given the intervention through their mobile phones.
Detailed description
Most children engage in insufficient amounts of moderate-to-vigorous physical activity. These low levels of moderate-to-vigorous physical activity are associated with adverse health consequences including increased risk for obesity, and cardiovascular and diabetes risk factors. Therefore, there is a need for studies that can increase physical activity levels in children. Mobile phones are a way to deliver behavioral interventions. Mobile phones are portable, allow for real-time data collection, and can potentially reach large numbers of people. Text messages can also be utilized to promote behavior change. Few mobile phone based interventions have specifically targeted child physical activity.
The aims of this pilot study were to determine the feasibility and efficacy of a physical activity promotion program targeting 6-10 year old children that is delivered to parents through mobile phones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile phone intervention: minimal | Active comparator | Behavioral: Intervention: limited behavioral strategiesIntervention: limited behavioral strategies |
| Mobile phone intervention: intensive | Experimental | Behavioral: Intervention: advanced behavioral strategiesIntervention: advanced behavioral strategies |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent must own a mobile phone.
- Parent must use the text (SMS)messaging service on their mobile phone.
- Parent can access the internet on their mobile phone.
Key exclusion criteria (3 listed)
- Child is 6 through 10 years old.
- Child does not engage in regular physical activity.
- Chile is physically capable of exercising.
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 |
|---|---|---|
| Intervention: limited behavioral strategiesParents are given access to a website, formatted for a mobile phone. The website provides parents with a target steps/day goal for their child and parents are instructed to use their mobile phone to access the study website to record their child's step count each night. Parents are also sent monthly healthy nutrition tips via text message targeting the child in order to provide these families with potentially health promoting information. | Behavioural | Mobile phone intervention: minimal |
| Intervention: advanced behavioral strategiesParents are given access to a website, formatted for a mobile phone. The website provides parents with a target steps/day goal for their child and parents are instructed to use their mobile phone to access the study website to record their child's step count each night. Parents also receive additional behavioral strategies based on the Social Cognitive Theory. The strategies are delivered through weekly articles posted on the website. Text messages are designed to prompt parents to encourage their child's physical activity, remind parents of behavioral concepts presented in the articles (article tip), and motivate parents to foster behavioral change in their child. | Behavioural | Mobile phone intervention: intensive |
Primary outcome
Step counts
Time frame: 3 Months
Physical activity will be measured by utilizing pedometers.
1 secondary outcome
Waist circumference, body mass index, blood pressure
Time frame: 3 Months
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 3 May 2016.
- Derived from this study: PubMed 25386899Newton RL Jr, Marker AM, Allen HR, Machtmes R, Han H, Johnson WD, Schuna JM Jr, Broyles ST, Tudor-Locke C, Church TS. Parent-targeted mobile phone intervention to increase physical activity in sedentary children: randomized pilot trial. JMIR Mhealth Uhealth. 2014 Nov 10;2(4):e48. doi: 10.2196/mhealth.3420.
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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.
Robert L. Newton, Jr., PhD principal investigator
Pennington Biomedical Research Center
Timothy Church, MD,MPH,PhD principal investigator
Pennington Biomedial 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 Intervention: limited behavioral strategies and Intervention: advanced behavioral strategies 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 3 inclusion and 3 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 3 May 2016. 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?
Step counts (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551108, which also lists 1 linked publication.
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 3 May 2016.