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Healthy Summer Learners

Primary Purpose

Overweight and Obesity, Academic Acheivement

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Healthy Summer Learners
21st Century Summer Learning Center
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Healthy Summer Learners

21st Century Learning Center

Passive control

Arm Description

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).

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

Children in this condition will not attend a summer program.

Outcomes

Primary Outcome Measures

Change in body mass index (BMI)
weight in kilograms and height in meters will be combined to report BMI in kg/m^2
Change in MAP reading score
MAP reading percentile

Secondary Outcome Measures

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
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
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
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
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
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
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
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

Full Information

First Posted
August 25, 2017
Last Updated
September 27, 2021
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03321071
Brief Title
Healthy Summer Learners
Official Title
Interventions to Promote Healthy Lifestyle and Academic Performance in Children During the Summer Months.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Academic Acheivement

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Summer Learners
Arm Type
Experimental
Arm Description
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).
Arm Title
21st Century Learning Center
Arm Type
Active Comparator
Arm Description
Children in this condition will attend a 21st Century Summer Learning Program.
Arm Title
Passive control
Arm Type
No Intervention
Arm Description
Children in this condition will not attend a summer program.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Summer Learners
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
21st Century Summer Learning Center
Intervention Description
Children in this condition will attend a 21st Century Summer Learning Program.
Primary Outcome Measure Information:
Title
Change in body mass index (BMI)
Description
weight in kilograms and height in meters will be combined to report BMI in kg/m^2
Time Frame
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
Title
Change in MAP reading score
Description
MAP reading percentile
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
Secondary Outcome Measure Information:
Title
Average daily time (minutes) spent in moderate to vigorous physical activity during the summer on days attending a program and not attending a program
Description
Moderate to vigorous physical activity will be collected via a wrist placed Fitbit
Time Frame
Moderate to vigorous physical activity will be collected daily from baseline to 12 weeks
Title
Average daily time (minutes) spent in sedentary behavior during the summer on days attending a program and not attending a program
Description
Sedentary time will be collected via a wrist placed Fitbit
Time Frame
Sedentary time will be collected daily from baseline to 12 weeks
Title
Average daily screen time (minutes) during the summer on days attending a program and not attending a program
Description
Screen time will be collected via parent proxy report during the summer
Time Frame
Screen time will be collected twice weekly from baseline to 12 weeks
Title
Average daily Number of healthy and unhealthy foods consumed on days attending a program and not attending a program
Description
Diet will be collected via food frequency questionnaires and a number of healthy and unhealthy foods consumed will be calculated
Time Frame
Diet will be collected twice weekly from baseline to 12 weeks
Title
Average daily sleep (minutes) during the summer on days attending a program and not attending a program
Description
Sleep time will be collected via a wrist placed Fitbit
Time Frame
Sleep will be collected daily from baseline to 12 weeks
Title
Average daily sleep onset during the summer on days attending a program and not attending a program
Description
Sleep onset will be collected via a wrist placed Fitbit
Time Frame
Sleep onset will be collected daily from baseline to 12 weeks
Title
Average daily sleep offset during the summer on days attending a program and not attending a program
Description
Sleep offset will be collected via a wrist placed Fitbit
Time Frame
Sleep offset will be collected daily from baseline to 12 weeks
Title
Average daily sleep midpoint during the summer on days attending a program and not attending a program
Description
Sleep midpoint will be collected via a wrist placed Fitbit
Time Frame
Sleep midpoint will be collected daily from baseline to 12 weeks
Other Pre-specified Outcome Measures:
Title
Cardiorespiratory fitness
Description
Cardiorespiratory fitness will be collected via the Fitnessgram PACER
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not share IPD data.
Citations:
PubMed Identifier
35339766
Citation
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.
Results Reference
derived
PubMed Identifier
32514369
Citation
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.
Results Reference
derived

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Healthy Summer Learners

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