Healthy Summer Learners

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321071
• Other study ID #: Pro00065094
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Summer vacation represents an important time away from the school setting for a majority of children attending public school in the US. This break is characterized by large amounts of free time and involvement in a wide variety of formal and informal activities, time spent with friends and family, and travel. Yet for many children, particularly those from low-income households, summer vacation represents a "window of vulnerability" in which dramatic declines in both health and academics occur. During the summer months (typically 3 months) children gain a larger amount of body weight compared to the amount of weight gained over the school year, and weight gain during summer reverses weight losses achieved during school. For academics, it is well established that children from low-income households experience greater declines in reading and math during the summer than their middle-to-upper income peers. Numerous programs that address these issues currently exist (e.g., summer school, summer weight loss or fitness programs). However, these programs are designed and delivered at the expense of the promotion or prevention of the other - academic focus without health or health focus without academics. Our long-term goal is to develop summer programming for widespread dissemination that addresses both lifestyle behaviors (i.e., physical activity and nutrition) and academic performance. The objective of the proposed study is to establish the effectiveness of an innovative "Healthy Summer Learners" (HSL) program for low-income, minority children. The rationale for the proposed research is that no summer programs incorporate curriculum that addresses both unhealthy weight gains and academic achievement simultaneously. This study seeks to fill this void by testing a prototype learning and health-oriented summer program focused on promoting physical activity and nutrition, along with content that provides quality learning experiences to develop reading and math skills. To accomplish this objective, this study will evaluate over 2 summers the effectiveness of a 6-week Healthy Summer Learners program delivered within a Boys & Girls Club summer camp using a randomized design in a sample of rising 2nd, 3rd, and 4th graders. The aims of the study are Aim 1: Evaluate the impact of Healthy Summer Learners on children's weight gain and academic performance from beginning (end of Spring school year) to the end of summer (beginning of Fall school year), and Aim 2: Evaluate the feasibility and acceptability of Healthy Summer Learners to children, parents, and program staff.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Academic Acheivement
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Healthy Summer Learners
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 Center
Children in this condition will attend a 21st Century Summer Learning Program.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiorespiratory fitness	Cardiorespiratory fitness will be collected via the Fitnessgram PACER	Cardiorespiratory fitness 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
Primary	Change in body mass index (BMI)	weight in kilograms and height in meters will be combined to report BMI in kg/m^2	Height and weight 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
Primary	Change in MAP reading score	MAP reading percentile	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	Average daily time (minutes) spent in moderate to vigorous physical activity during the summer on days attending a program and not attending a program	Moderate to vigorous physical activity will be collected via a wrist placed Fitbit	Moderate to vigorous physical activity will be collected daily from baseline to 12 weeks
Secondary	Average daily time (minutes) spent in sedentary behavior during the summer on days attending a program and not attending a program	Sedentary time will be collected via a wrist placed Fitbit	Sedentary time will be collected daily from baseline to 12 weeks
Secondary	Average daily screen time (minutes) during the summer on days attending a program and not attending a program	Screen time will be collected via parent proxy report during the summer	Screen time will be collected twice weekly from baseline to 12 weeks
Secondary	Average daily Number of healthy and unhealthy foods consumed on days attending a program and not attending a program	Diet will be collected via food frequency questionnaires and a number of healthy and unhealthy foods consumed will be calculated	Diet will be collected twice weekly from baseline to 12 weeks
Secondary	Average daily sleep (minutes) during the summer on days attending a program and not attending a program	Sleep time will be collected via a wrist placed Fitbit	Sleep will be collected daily from baseline to 12 weeks
Secondary	Average daily sleep onset during the summer on days attending a program and not attending a program	Sleep onset will be collected via a wrist placed Fitbit	Sleep onset will be collected daily from baseline to 12 weeks
Secondary	Average daily sleep offset during the summer on days attending a program and not attending a program	Sleep offset will be collected via a wrist placed Fitbit	Sleep offset will be collected daily from baseline to 12 weeks
Secondary	Average daily sleep midpoint during the summer on days attending a program and not attending a program	Sleep midpoint will be collected via a wrist placed Fitbit	Sleep midpoint will be collected daily from baseline to 12 weeks