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Completed

NCT Number: NCT03321071

Healthy Summer Learners

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.

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Key information

Conditions

Overweight and Obesity Academic Acheivement Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of South Carolina

Columbia, South Carolina, 29205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Summer Learners

Behavioral

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

Behavioral

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

Primary outcomes

  1. Change in Body Mass Index (BMI) Z-score

    Time frame: Body mass index 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

    Measure Description: Centers for Disease Control age and sex-specific Body Mass Index z-scores. A z-score of 0 represents the population mean. Higher or lower z-scores could represent better or worse outcomes as too low could be underweight and too high could indicate overweight or obesity.

    Children above the 85th percentile are considered overweight while children above the 95th percentile are considered obese

  2. Change in Measures of Academic Progress Reading Scores

    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

    Measure Description: Created by the Northwest Evaluation Association (www.nwea.org), MAP results are widely accepted and used extensively in school-aged children. Scores are reported using the Rasch Unit Scale, a curriculum scale developed using Item Response Theory that estimates student achievement. The Rasch Unit Scale ranges from 140-300 and are norm referenced based on grade. Higher scores indicate better reading profeciency.

Secondary outcomes

  1. Average Minutes Per Day 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. Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending. No change is indicated for the passive control as they did not attend a program. Passive control never attended a structured summer program thus no change can be calculated.

  2. Average Minutes Per Day 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. Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending. No change is indicated for the passive control as they did not attend a program. Passive control never attended a structured summer program thus no change can be calculated.

  3. Average Minutes Per Day Screen Time 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. Passive control never attended a structured summer program thus no change can be calculated.

  4. Average Number of Healthy Foods Consumed/Day 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 the number of healthy and unhealthy foods consumed will be calculated. Negative numbers mean the number of healthy foods consumed decreased on days attending while positive numbers indicate the number of healthy foods consumed increased on days attending. No change is indicated for the passive control as they did not attend a program. Passive control never attended a structured summer program thus no change can be calculated.

  5. Average Minutes Per Day of Sleep 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. Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending. No change is indicated for the passive control as they did not attend a program.

  6. Average Minutes Per Day Shift in 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. Negative numbers indicate sleep onset was earlier on days attending while positive numbers indicate sleep onset was later on days attending. No change is indicated for the passive control as they did not attend a program.

  7. Average Minutes Per Day Shift in 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. Negative numbers mean sleep offset was earlier on days attending while positive numbers indicate sleep offset was later on days attending. No change is indicated for the passive control as they did not attend a program.

  8. Average Minutes Per Day Shift in 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. Negative numbers mean midpoint was earlier on days attending while positive numbers indicate midpoint was later on days attending. No change is indicated for the passive control as they did not attend a program.

Other outcomes

  1. Change in Progressive Aerobic Cardiovascular Endurance Run Laps

    Time frame: Change in Progressive Aerobic Cardiovascular Endurance Run Laps 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

    Children were instructed to run from one cone marker to another cone placed at a length of 20 meters. Music and voice instructions were used to prompt children to run and stop within an allotted amount of time. As the test progressed, the allotted time to run the 20 meters incrementally decreased. If the child failed to reach the cone/marker within the allotted time frame on two occasions the test was ended, and the laps score was recorded.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 25, 2017
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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