- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321071
Healthy Summer Learners
Interventions to Promote Healthy Lifestyle and Academic Performance in Children During the Summer Months.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29205
- University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- MAP scores are norm referenced based on typical grade level scores. Students that have scored between the 25th and 75th percentile will be eligible to participate in the study.
Exclusion Criteria:
- children with severe intellectual or physical disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Summer Learners
Similar to typical summer day camp procedures, students attending Healthy Summer Learners will be dropped-off and picked-up at camp.
The physical activity component of the program was designed with the expertise and input from B&G Club youth program staff.
The academic component was informed by school district personnel.
The program was also designed to be analogous to typical summer day camp program in terms of operating weeks (10 weeks) length of program day (i.e., 8am-5pm), and program component time blocks (~45min-1hr time blocks).
|
Physical Activity Component. The physical activity component of Healthy Summer Learners is designed to engage children in moderate-to-vigorous physical activity (MVPA) for at least 50% of the time. With 3 hours each day dedicated to physical activity, this translates into children accumulating 90 minutes of MVPA daily. This is 30 minutes above the 60 minutes of MVPA each day recommended by the Physical Activity Guidelines for Americans. Nutrition Component. The nutrition component of Healthy Summer Learners is designed to provide healthy snacks and meals and nutrition education via standardized pre-existing curricula. Food/Beverage Guidelines. Meals will follow the USDA Nutrition Standards for the National School Lunch and School Breakfast Programs. Academic Component. The academic component will consist of existing, effective academic programs focused on Math and Reading. |
|
Active Comparator: 21st Century Learning Center
Children in this condition will attend a 21st Century Summer Learning Program.
|
Children in this condition will attend a 21st Century Summer Learning Program.
|
|
No Intervention: Passive control
Children in this condition will not attend a summer program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Mass Index (BMI) Z-score
Time Frame: Body mass index will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
|
Measure Description: Centers for Disease Control age and sex-specific Body Mass Index z-scores. A z-score of 0 represents the population mean. Higher or lower z-scores could represent better or worse outcomes as too low could be underweight and too high could indicate overweight or obesity. Children above the 85th percentile are considered overweight while children above the 95th percentile are considered obese |
Body mass index will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
|
|
Change in Measures of Academic Progress Reading Scores
Time Frame: MAP reading scores will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
|
Measure Description: Created by the Northwest Evaluation Association (www.nwea.org),
MAP results are widely accepted and used extensively in school-aged children.
Scores are reported using the Rasch Unit Scale, a curriculum scale developed using Item Response Theory that estimates student achievement.
The Rasch Unit Scale ranges from 140-300 and are norm referenced based on grade.
Higher scores indicate better reading profeciency.
|
MAP reading scores will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Minutes Per Day Spent in Moderate to Vigorous Physical Activity During the Summer on Days Attending a Program and Not Attending a Program
Time Frame: Moderate to vigorous physical activity will be collected daily from baseline to 12 weeks
|
Moderate to vigorous physical activity will be collected via a wrist placed Fitbit.
Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending.
No change is indicated for the passive control as they did not attend a program.
Passive control never attended a structured summer program thus no change can be calculated.
|
Moderate to vigorous physical activity will be collected daily from baseline to 12 weeks
|
|
Average Minutes Per Day Spent in Sedentary Behavior During the Summer on Days Attending a Program and Not Attending a Program
Time Frame: Sedentary time will be collected daily from baseline to 12 weeks
|
Sedentary time will be collected via a wrist placed Fitbit.
Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending.
No change is indicated for the passive control as they did not attend a program.
Passive control never attended a structured summer program thus no change can be calculated.
|
Sedentary time will be collected daily from baseline to 12 weeks
|
|
Average Minutes Per Day Screen Time During the Summer on Days Attending a Program and Not Attending a Program
Time Frame: Screen time will be collected twice weekly from baseline to 12 weeks
|
Screen time will be collected via parent proxy report during the summer.
Passive control never attended a structured summer program thus no change can be calculated.
|
Screen time will be collected twice weekly from baseline to 12 weeks
|
|
Average Number of Healthy Foods Consumed/Day on Days Attending a Program and Not Attending a Program
Time Frame: Diet will be collected twice weekly from baseline to 12 weeks
|
Diet will be collected via food frequency questionnaires and the number of healthy and unhealthy foods consumed will be calculated.
Negative numbers mean the number of healthy foods consumed decreased on days attending while positive numbers indicate the number of healthy foods consumed increased on days attending.
No change is indicated for the passive control as they did not attend a program.
Passive control never attended a structured summer program thus no change can be calculated.
|
Diet will be collected twice weekly from baseline to 12 weeks
|
|
Average Minutes Per Day of Sleep During the Summer on Days Attending a Program and Not Attending a Program
Time Frame: Sleep will be collected daily from baseline to 12 weeks
|
Sleep time will be collected via a wrist placed Fitbit.
Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending.
No change is indicated for the passive control as they did not attend a program.
|
Sleep will be collected daily from baseline to 12 weeks
|
|
Average Minutes Per Day Shift in Sleep Onset During the Summer on Days Attending a Program and Not Attending a Program.
Time Frame: Sleep onset will be collected daily from baseline to 12 weeks
|
Sleep onset will be collected via a wrist placed Fitbit.
Negative numbers indicate sleep onset was earlier on days attending while positive numbers indicate sleep onset was later on days attending.
No change is indicated for the passive control as they did not attend a program.
|
Sleep onset will be collected daily from baseline to 12 weeks
|
|
Average Minutes Per Day Shift in Sleep Offset During the Summer on Days Attending a Program and Not Attending a Program
Time Frame: Sleep offset will be collected daily from baseline to 12 weeks
|
Sleep offset will be collected via a wrist-placed Fitbit.
Negative numbers mean sleep offset was earlier on days attending while positive numbers indicate sleep offset was later on days attending.
No change is indicated for the passive control as they did not attend a program.
|
Sleep offset will be collected daily from baseline to 12 weeks
|
|
Average Minutes Per Day Shift in Sleep Midpoint During the Summer on Days Attending a Program and Not Attending a Program
Time Frame: Sleep midpoint will be collected daily from baseline to 12 weeks
|
Sleep midpoint will be collected via a wrist placed Fitbit.
Negative numbers mean midpoint was earlier on days attending while positive numbers indicate midpoint was later on days attending.
No change is indicated for the passive control as they did not attend a program.
|
Sleep midpoint will be collected daily from baseline to 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Progressive Aerobic Cardiovascular Endurance Run Laps
Time Frame: Change in Progressive Aerobic Cardiovascular Endurance Run Laps will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
|
Children were instructed to run from one cone marker to another cone placed at a length of 20 meters.
Music and voice instructions were used to prompt children to run and stop within an allotted amount of time.
As the test progressed, the allotted time to run the 20 meters incrementally decreased.
If the child failed to reach the cone/marker within the allotted time frame on two occasions the test was ended, and the laps score was recorded.
|
Change in Progressive Aerobic Cardiovascular Endurance Run Laps will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- von Klinggraeff L, Dugger R, Brazendale K, Hunt ET, Moore JB, Turner-McGrievy G, Vogler K, Beets MW, Armstrong B, Weaver RG. Healthy Summer Learners: An explanatory mixed methods study and process evaluation. Eval Program Plann. 2022 Jun;92:102070. doi: 10.1016/j.evalprogplan.2022.102070. Epub 2022 Mar 17.
- Dugger R, Brazendale K, Hunt ET, Moore JB, Turner-McGrievy G, Vogler K, Beets MW, Armstrong B, Weaver RG. The impact of summer programming on the obesogenic behaviors of children: behavioral outcomes from a quasi-experimental pilot trial. Pilot Feasibility Stud. 2020 May 28;6:78. doi: 10.1186/s40814-020-00617-x. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00065094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight and Obesity
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
National University Health System, SingaporeActive, not recruitingObesity | Overweight and/or Obesity | Overweight or Obese Adults | Overweight , ObesitySingapore
-
National Taiwan University HospitalCompleted
-
PfizerNot yet recruitingObesity | Overnutrition | Nutrition Disorders | Overweight | Body Weight | Overweight or Obesity | Overweight and/or Obesity | Nutritional and Metabolic DiseasesUnited States
-
University of Texas Southwestern Medical CenterChildren's Medical Center DallasRecruitingPediatric Obesity | Pediatric Overweight | Overweight , ObesityUnited States
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal
Clinical Trials on Healthy Summer Learners
-
University of MiamiNational Institutes of Health (NIH); Patricia and Phillip Frost Museum of Science... and other collaboratorsCompleted
-
Ohio State UniversityNationwide Children's HospitalCompletedChildhood ObesityUnited States
-
University of South CarolinaCompleted
-
Florida International UniversityNational Institute of Mental Health (NIMH)CompletedADHD | Disruptive Behaviours
-
University of Central FloridaNational Institute of Nursing Research (NINR)RecruitingObesity & OverweightUnited States
-
University of South CarolinaRecruitingPediatric Obesity | Socioeconomic Factors | Health Status Disparities | Ethnic GroupsUnited States
-
University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Northern Arizona UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedObesity, ChildhoodUnited States
-
Florida International UniversityThe Children's Trust, Miami FLCompletedExternalizing BehaviorUnited States
-
University of HoustonNational Institute on Minority Health and Health Disparities (NIMHD)CompletedObesity, Childhood | Healthy Lifestyle | Behavior, HealthUnited States