Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03397940 |
| Other study ID # |
Pro00065211 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
October 1, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
University of South Carolina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Summer vacation is a 3-month window of vulnerability for children from low-income households
when health behaviors and academic learning decay. The goal of this project is to collect
information on where low-income children go during summer, what they do when they get there,
and how their behaviors (physical activity, sedentary, sleep, and diet) differ between the
summer (unstructured days) and school year (structured days). This study is 1) significant
because it will provide evidence on potential points of intervention that can reduce or
reverse the excessive unhealthy weight gains that occur during summer and 2) innovative
because it will be the first to identify changes in activity, sedentary, sleep, and dietary
behaviors during prolonged and shorter periodic breaks from school and link these behaviors
to changes in zBMI over time.
Description:
For children (5-12yrs) from low-income households, summer vacation is a "window of
vulnerability" and represents an extended period of time (typically 9-10 weeks) in which
declines in academic performance occur. For 30 years, empirical evidence has indicated that
children from low-income households experience greater declines in reading and math skills
during the summer vacation than their middle-to-upper income peers. Additionally, a growing
body of evidence demonstrates that the amount of weight gained during summer vacation is 3-5
times greater than the amount of weight gained during the school year. Moreover, this
excessive weight gain during summer is more pronounced for low-income, minority children, the
same children experiencing the greatest summer learning loss. What children eat and drink,
the types of physical activity opportunities, and the amount of screen-time and sleep (two
important correlates of weight gain) they engage in during summer vacation is unknown.
However, a substantial body of literature indicates that children engage in a greater number
of obesogenic behaviors during less-structured times (e.g., weekend days) compared to
more-structured times (e.g., week/school days). This phenomenon is refered to as the
Structured Days Hypothesis. These behaviors include 1) increased time spent sedentary, 2)
reduced engagement in physical activity, 3) displaced sleep patterns, and 4) unhealthy
dietary patterns. This study hypothesizes that summer vacation is simply one long weekend
where the effect of children's obesogenic behaviors on weight are compounded over a three
month time period. However, should children be involved in a structured program over the
summer they would not engage in obesogenic behaviors and they would not experience unhealthy
weight gains and fitness loss. Recently, one school district in the Columbia, SC area adopted
a year-round calendar for an elementary school. This provides a unique opportunity to conduct
a natural experiment examining the effects of shorter periodic breaks vs. one prolonged break
from structured days (i.e., school days) on the obesogenic behaviors, weight gain, and
fitness. This study will use a two arm accelerated longitudinal cohort design to complete the
following specific aims: Aim 1: Compare changes in BMI z-scores and fitness during the
traditional 3-month summer and 9-month school year between children attending a school that
follows a year-round school calendar to children attending match-paired schools that follow a
traditional school calendar. Aim 2: Compare changes in sleep, physical activity, sedentary
behaviors, and diet during the traditional 3-month summer and 9-month school year between
children attending a school that follows a year-round school calendar to children attending
match-paired schools that follow a traditional school calendar. This study is significant
because the reason for children's weight gain and fitness loss during the summer is unknown.
This study is innovative because no studies have examined the effects of prolonged (9 weeks
all at once) vs. periodic breaks (3 week breaks distributed throughout the year) from a
structured environment on children's weight and fitness.
