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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01551108
Other study ID # PBRC 11022
Secondary ID
Status Completed
Phase N/A
First received March 8, 2012
Last updated May 2, 2016
Start date March 2012
Est. completion date August 2013

Study information

Verified date May 2016
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 10 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Pennington Biomedical Research Center The Coca-Cola Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Step counts Physical activity will be measured by utilizing pedometers. 3 Months No
Secondary 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. 3 Months No
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