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Healthy Summer Learners

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ClinicalTrials.gov Identifier: NCT03321071
Recruitment Status : Active, not recruiting
First Posted : October 25, 2017
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
R. Glenn Weaver, University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Academic Acheivement Behavioral: Healthy Summer Learners Behavioral: 21st Century Summer Learning Center Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interventions to Promote Healthy Lifestyle and Academic Performance in Children During the Summer Months.
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2021

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).
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.


Active Comparator: 21st Century Learning Center
Children in this condition will attend a 21st Century Summer Learning Program.
Behavioral: 21st Century Summer Learning Center
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.



Primary Outcome Measures :
  1. Change in body mass index (BMI) [ 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 ]
    weight in kilograms and height in meters will be combined to report BMI in kg/m^2

  2. Change in MAP reading score [ 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 ]
    MAP reading percentile


Secondary Outcome Measures :
  1. Average daily time (minutes) 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

  2. Average daily time (minutes) 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

  3. Average daily screen time (minutes) 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

  4. Average daily Number of healthy and unhealthy foods consumed 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 a number of healthy and unhealthy foods consumed will be calculated

  5. Average daily sleep (minutes) 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

  6. Average daily 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

  7. Average daily 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

  8. Average daily 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


Other Outcome Measures:
  1. Cardiorespiratory fitness [ 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 ]
    Cardiorespiratory fitness will be collected via the Fitnessgram PACER



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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321071


Locations
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United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29205
Sponsors and Collaborators
University of South Carolina
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: R. Glenn Weaver, Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT03321071    
Other Study ID Numbers: Pro00065094
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not share IPD data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight