- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01551108
Parent-targeted Mobile Phone Based Intervention to Increase Physical Activity in Children (P-Mobile)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Child is 6 through 10 years old.
- Child does not engage in regular physical activity.
- Chile is physically capable of exercising.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mobile phone intervention: minimal
Intervention: limited behavioral strategies
|
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.
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Experimental: Mobile phone intervention: intensive
Intervention: advanced behavioral strategies
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Step counts
Time Frame: 3 Months
|
Physical activity will be measured by utilizing pedometers.
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist circumference, body mass index, blood pressure
Time Frame: 3 Months
|
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.
|
3 Months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert L. Newton, Jr., PhD, Pennington Biomedical Research Center
- Principal Investigator: Timothy Church, MD,MPH,PhD, Pennington Biomedial Research Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PBRC 11022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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