CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 180 enrolled
Drug / intervention
Healthy Summer Learners +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03321071
NCT03321071Phase 1Completed

Interventions to Promote Healthy Lifestyle and Academic Performance in Children During the Summer Months.

University of South Carolina·interventional·Posted Oct 25, 2017·Updated Jul 5, 2024

In Brief

A Phase 1 clinical trial evaluating Healthy Summer Learners and 21st Century Summer Learning Center for Overweight and Obesity and Academic Acheivement. Completed, enrolled 180 participants across 1 site.

Detailed Summary

Summer vacation represents a "window of vulnerability" where dramatic declines in both health and academics occur for elementary age children. Currently, there are no summer programs that incorporate curriculum addressing both unhealthy weight gains and academic achievement simultaneously. This work represents an important step towards addressing important public health goals - obesity and learning - through a comprehensive program delivered during a timeframe - summer vacation - where substantial and long-lasting negative effects occur.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 25, 2017
Enrollment StartMay 1, 2018
Primary CompletionMay 1, 2020
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 8.7 years ago

Interventions

Healthy Summer Learnersbehavioral

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.

21st Century Summer Learning Centerbehavioral

Children in this condition will attend a 21st Century Summer Learning Program.