Healthy Summer Learners

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03321071

Enrollment

180

Registered

2017-10-25

Start date

2018-05-01

Completion date

2021-05-01

Last updated

2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Academic Acheivement, Overweight and Obesity

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.

Interventions

BEHAVIORALHealthy 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.

BEHAVIORAL21st Century Summer Learning Center

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 9 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Measures of Academic Progress Reading Scores	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.
Change in Body Mass Index (BMI) Z-score	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

Secondary

Measure	Time frame	Description
Average Minutes Per Day Shift in Sleep Midpoint During the Summer on Days Attending a Program and Not Attending a Program	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.
Average Minutes Per Day Spent in Sedentary Behavior During the Summer on Days Attending a Program and Not Attending a Program	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.
Average Minutes Per Day Screen Time During the Summer on Days Attending a Program and Not Attending a Program	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.
Average Minutes Per Day of Sleep During the Summer on Days Attending a Program and Not Attending a Program	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.
Average Minutes Per Day Shift in Sleep Onset During the Summer on Days Attending a Program and Not Attending a Program.	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.
Average Minutes Per Day Shift in Sleep Offset During the Summer on Days Attending a Program and Not Attending a Program	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.
Average Number of Healthy Foods Consumed/Day on Days Attending a Program and Not Attending a Program	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.
Average Minutes Per Day 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 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.

Other

Measure	Time frame	Description
Change in Progressive Aerobic Cardiovascular Endurance Run Laps	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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). 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.	60
21st Century Learning Center Children in this condition will attend a 21st Century Summer Learning Program. 21st Century Summer Learning Center: Children in this condition will attend a 21st Century Summer Learning Program.	60
Passive Control Children in this condition will not attend a summer program.	60
Total	180

Baseline characteristics

Characteristic	Healthy Summer Learners	21st Century Learning Center	Passive Control	Total
Age, Categorical <=18 years	60 Participants	60 Participants	60 Participants	180 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Continuous	7.9 years STANDARD_DEVIATION 1	7.9 years STANDARD_DEVIATION 1	8.0 years STANDARD_DEVIATION 1	7.9 years STANDARD_DEVIATION 1
BMI z-score	0.99 units on a scale STANDARD_DEVIATION 1.1	0.99 units on a scale STANDARD_DEVIATION 1.1	0.95 units on a scale STANDARD_DEVIATION 1.1	0.98 units on a scale STANDARD_DEVIATION 1.1
Measures of Academic Progress Reading Scores	190.8 units on a scale STANDARD_DEVIATION 12	192.6 units on a scale STANDARD_DEVIATION 13.5	194 units on a scale STANDARD_DEVIATION 11.6	192.5 units on a scale STANDARD_DEVIATION 12.4
PACER Laps Completed	13.5 Laps STANDARD_DEVIATION 7.4	13.5 Laps STANDARD_DEVIATION 7.4	11.6 Laps STANDARD_DEVIATION 6.9	12.9 Laps STANDARD_DEVIATION 7.2
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	55 Participants	56 Participants	56 Participants	167 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	5 Participants	4 Participants	4 Participants	13 Participants
Region of Enrollment United States	60 participants	60 participants	60 participants	180 participants
Sex: Female, Male Female	31 Participants	43 Participants	33 Participants	107 Participants
Sex: Female, Male Male	29 Participants	17 Participants	27 Participants	73 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 60	0 / 60	0 / 60
other Total, other adverse events	0 / 60	0 / 60	0 / 60
serious Total, serious adverse events	0 / 60	0 / 60	0 / 60

Outcome results

Primary

Change in Body Mass Index (BMI) Z-score

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

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Healthy Summer Learners	Change in Body Mass Index (BMI) Z-score	0.03 z-score
21st Century Learning Center	Change in Body Mass Index (BMI) Z-score	0.02 z-score
Passive Control	Change in Body Mass Index (BMI) Z-score	0.06 z-score

Primary

Change in Measures of Academic Progress Reading Scores

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.

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Healthy Summer Learners	Change in Measures of Academic Progress Reading Scores	1.8 units on a scale
21st Century Learning Center	Change in Measures of Academic Progress Reading Scores	0.7 units on a scale
Passive Control	Change in Measures of Academic Progress Reading Scores	0.9 units on a scale

Secondary

Average Minutes Per Day of Sleep During the Summer on Days Attending a Program and Not Attending a Program

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.

Time frame: Sleep will be collected daily from baseline to 12 weeks