Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
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|ClinicalTrials.gov Identifier: NCT03304249|
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss||Behavioral: iAmHealthy Healthy Lifestyles Program Other: Newsletter||Not Applicable|
This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss program to kids and families in rural settings. This study will include kids from schools in rural cities/counties, and their parents, and they will be randomly assigned to a group by their school.
The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It delivers behavioral, nutritional, and physical activity topics for kids and their families. The total length of the intervention will be about 8 months, which coincides with the length of a typical school year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention|
|Actual Study Start Date :||October 13, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.
Behavioral: iAmHealthy Healthy Lifestyles Program
iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.
Active Comparator: Control
Participants randomized to this group receive comparable content delivered via a newsletter.
Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.
- Change in Child Body Mass Index z Score (BMIz) [ Time Frame: Change from Baseline to Month 8 ]
- Change in Child Body Mass Index z Score (BMIz) [ Time Frame: Change from Baseline to Month 20 ]
- Physical activity - average time [ Time Frame: Baseline, Month 8, Month 20 ]Measured using ActiGraph physical activity monitors. Outcome will be calculated as the average (across valid wear days) time spent per day in moderate to vigorous physical activity (MVPA).
- Physical activity - % time [ Time Frame: Baseline, Month 8, Month 20 ]Measured using ActiGraph physical activity monitors. Outcome will be calculated as the percentage of time time spent per day in MVPA.
- Photo-assisted 24 hour food recall (24hr FR) [ Time Frame: Baseline, Month 8, Month 20 ]The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
- Parent Body Mass Index (BMI) [ Time Frame: Baseline, Month 8, Month 20 ]
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): NCT03304249
|Contact: Kelsey Dean, RDfirstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Ann M Davis, PhD, MPH, ABPP||University of Kansas Medical Center|