Role of Structured Days on Weight Gain
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|ClinicalTrials.gov Identifier: NCT03397940|
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : November 13, 2020
|Condition or disease|
|Body Weight Cardio-respiratory Fitness Sleep Nutrition Poor Physical Activity Screen Time|
|Study Type :||Observational|
|Estimated Enrollment :||907 participants|
|Official Title:||Investigating the Role of Structured Days on Accelerated Weight Gain During Summer: A Natural Experiment|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Year Round School
Children attending year round school
Children attending a traditional school with a traditional calendar school year
- Change in Body Mass Index [ Time Frame: Baseline and will follow up at 4 months, 12 months, 16 months, and 24 months ]All students enrolled in the partnering schools will have their height and weight measured using standard procedures, as part of their routine PE class. Height and weight will be collected prior to and following every break lasting 3 weeks or longer. These measures will be collected with the help of trained research staff during regularly scheduled PE classes to ensure data quality. This information will be used to compare the BMI (translated into age/sex z-scores [zBMI] for analytical modeling) over time and between students attending a year-round school and traditional schools. These tests are valid and reliable for this age group.
- Change in Cardiorespiratory Fitness: [ Time Frame: Baseline and will follow up at 4 months, 12 months, 16 months, and 24 months ]All students enrolled in the partnering schools will take part in the cardiovascular fitness (CVF) test (i.e., PACER) as part of their routine PE class. These tests are administered to this age group and occur as part of regular PE class as part of a South Carolina statewide assessment system.This information will be used to compare the CVF over time and between students attending a year-round school and traditional schools. These tests are valid and reliable for this age group.
- Change in Sleep [ Time Frame: Baseline and follow up at 3 months, 12 months, and 15 months ]Children's sleep will be assessed via wrist-placed Actigraph Links.
- Change in Dietary Behavior [ Time Frame: Baseline and follow up at 3 months, 12 months, and 15 months ]Dietary patterns rather than individual foods will be assessed. For the current study, the intent is to estimate less healthful/more healthful foods and beverages consumed and compare these between summer and school. The study will assess child dietary patterns using two approaches. First, a modified dietary screener questionnaire will be completed by a parent/guardian at each measurement (traditional school and summer vacation) each year. Screener items were selected from multiple screeners developed for use in this age group and have been widely used in research. The screeners are the 26-item Dietary Screener Questionnaire,16 items from the National Youth Physical Activity and Nutrition Study, and items from several additional food/beverage validated screeners. These dietary screeners provide accurate estimates of food groups and dietary patterns, to allow for examination of relationships between diet and other variables in this study. These screeners have been tested for validity
- Change in Physical Activity [ Time Frame: Baseline and follow up at 3 months, 12 months, and 15 months ]Time (minutes per day) spent sedentary, and in light, moderate, and vigorous physical activity will be collected using a non-dominant wrist-placed ActiGraph Link for 9-days (common timeframe to collect physical activity data). Non-dominant wrist-placement provides an advantage over waist placement by improving compliance and the ability to collect information regarding sleep. The device is water-proof, allowing us to capture water activities during summer. A calibration/validation study was recently published to establish methodology to distill activity-intensities from wrist-placed ActiGraph in children. The widely accepted protocols for a valid day of data will be used. Each parent with receive a logbook to complete each night to report non-wear time. Logs will be cross-referenced with the accelerometer data for quality assurance.
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): NCT03397940
|Contact: Robert G Weaver, Phdemail@example.com|
|United States, South Carolina|
|University of South Carolina||Recruiting|
|Columbia, South Carolina, United States, 29205|
|Contact: Robert G Weaver firstname.lastname@example.org|