Phase 1
N=180
Healthy Summer Learners
Overweight and Obesity · Academic Acheivement
Bottom Line
View on ClinicalTrials.gov: NCT03321071 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Body Mass Index (BMI) Z-score — 0.03; 0.02; 0.06 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Healthy Summer Learners (Behavioral); 21st Century Summer Learning Center (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- University of South Carolina
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Mass Index (BMI) Z-score |
0.03; 0.02; 0.06 | — |
| PRIMARY Change in Measures of Academic Progress Reading Scores |
1.8; 0.7; 0.9 | — |
| SECONDARY Average Minutes Per Day Spent in Moderate to Vigorous Physical Activity During the Summer on Days Attending a Program and Not Attending a Program |
51.2; 15.0 | — |
| SECONDARY Average Minutes Per Day Spent in Sedentary Behavior During the Summer on Days Attending a Program and Not Attending a Program |
-138.8; -80.2 | — |
| SECONDARY Average Minutes Per Day Screen Time During the Summer on Days Attending a Program and Not Attending a Program |
-44.0; -57.3 | — |
| SECONDARY Average Number of Healthy Foods Consumed/Day on Days Attending a Program and Not Attending a Program |
0.06; -0.17 | — |
| SECONDARY Average Minutes Per Day of Sleep During the Summer on Days Attending a Program and Not Attending a Program |
-20.6; -16.2 | — |
| SECONDARY Average Minutes Per Day Shift in Sleep Onset During the Summer on Days Attending a Program and Not Attending a Program. |
-52.9; -88.2 | — |
| SECONDARY Average Minutes Per Day Shift in Sleep Offset During the Summer on Days Attending a Program and Not Attending a Program |
-95.5; -104.8 | — |
| SECONDARY Average Minutes Per Day Shift in Sleep Midpoint During the Summer on Days Attending a Program and Not Attending a Program |
-73.3; -99.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03321071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.