Body WeightNCT03397940
Role of Structured Days on Weight Gain
An observational study of Body Weight and Cardio-respiratory Fitness, run by University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Body Weight, Cardio-respiratory Fitness, Sleep
- How many people
- 2,279 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- Child
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.
Who may be able to join
- K, 1st, 2nd, and 3rd grade students without any physical and/or medical conditions that would limit their ability to take part in measurements.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29205
About this study
Official title: Investigating the Role of Structured Days on Accelerated Weight Gain During Summer: A Natural Experiment
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.
Read the detailed 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.
- Conditions
- Body Weight, Cardio-respiratory Fitness, Sleep, Nutrition Poor, Physical Activity, Screen Time
- Medical subject headings
- Body Weight, Malnutrition, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Year Round School | Children attending year round school | |
| Traditional School | Children attending a traditional school with a traditional calendar school year |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and will follow up at 4 months, 12 months, 16 months, and 24 months
Secondary outcomes (3)
Change in Sleep
Children's sleep will be assessed via wrist-placed Actigraph Links.
Measured: Baseline and follow up at 3 months, 12 months, and 15 months
Change in Dietary Behavior
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
Measured: Baseline and follow up at 3 months, 12 months, and 15 months
Change in Physical Activity
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.
Measured: Baseline and follow up at 3 months, 12 months, and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Mar 2018
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Glenn Weaver, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397940
- Sponsor's protocol ID
- Pro00065211
- Status last verified
- May 2022
- First submitted
- 10 Nov 2017
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33243252
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Structured Days on Accelerated Weight Gain During Summer: A Natural Experiment
- ClinicalTrials.gov ID
- NCT03397940
- Acronym / sponsor ID
- Pro00065211
- Conditions
- Body Weight, Cardio-respiratory Fitness, Sleep, Nutrition Poor, Physical Activity, Screen Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,279 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Year Round School | – | –Children attending year round school |
| Traditional School | – | –Children attending a traditional school with a traditional calendar school year |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- K, 1st, 2nd, and 3rd grade students without any physical and/or medical conditions that would limit their ability to take part in measurements.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Change in Sleep
Time frame: Baseline and follow up at 3 months, 12 months, and 15 months
Change in Dietary Behavior
Time frame: Baseline and follow up at 3 months, 12 months, and 15 months
Change in Physical Activity
Time frame: Baseline and follow up at 3 months, 12 months, and 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 33243252Weaver 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.
Related trials for Body Weight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight and Cardio-respiratory Fitness, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (time frame: Baseline and will follow up at 4 months, 12 months, 16 months, and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.