NCT03397940

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

3.6 years

First QC Date

November 10, 2017

Last Update Submit

May 4, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Body Mass Index

    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.

    Baseline and will follow up at 4 months, 12 months, 16 months, and 24 months

  • Change in Cardiorespiratory Fitness:

    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.

    Baseline and will follow up at 4 months, 12 months, 16 months, and 24 months

Secondary Outcomes (3)

  • Change in Sleep

    Baseline and follow up at 3 months, 12 months, and 15 months

  • Change in Dietary Behavior

    Baseline and follow up at 3 months, 12 months, and 15 months

  • Change in Physical Activity

    Baseline and follow up at 3 months, 12 months, and 15 months

Study Arms (2)

Year Round School

Children attending year round school

Traditional School

Children attending a traditional school with a traditional calendar school year

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Three schools (2 traditional and 1 year-round) enrolling 1,279 students have agreed to participate. 85.0% of children in these schools qualify for free and/or reduced price lunch, and 67.5% of children attending these schools are black, 28.5% are white, and 3.6% are Hispanic. The first school was selected to participate because it operates on a year-round calendar. The second and third schools were selected because their enrollment size and student demographics closely match the enrollment and student demographics of the first school. All children in the participating schools will have their height/weight and cardiovascular fitness measured.

You may qualify if:

  • K, 1st, 2nd, and 3rd grade students without any physical and/or medical conditions that would limit their ability to take part in measurements.

You may not qualify if:

  • Children in the 4th and 5th grade will be excluded from participation in the obesogenic behavior assessments because they will move out of elementary school over the two-year study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29205, United States

Location

Related Publications (1)

  • Weaver RG, Armstrong B, Hunt E, Beets MW, Brazendale K, Dugger R, Turner-McGrievy G, Pate RR, Maydeu-Olivares A, Saelens B, Youngstedt SD. The impact of summer vacation on children's obesogenic behaviors and body mass index: a natural experiment. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):153. doi: 10.1186/s12966-020-01052-0.

MeSH Terms

Conditions

Body WeightMalnutritionMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 10, 2017

First Posted

January 12, 2018

Study Start

March 1, 2018

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations