Healthy Summer Learners

NCT03321071 | Completed Phase 1 Results DMC

• 1 other identifier: Pro00065094
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Academic Acheivement

Outcome Measures

Primary Outcomes (2)

• 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

  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

• 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.

  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 Outcomes (8)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (1)

• 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

Study Arms (3)

Healthy Summer Learners

EXPERIMENTAL

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

21st Century Learning Center

ACTIVE COMPARATOR

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

Behavioral: 21st Century Summer Learning Center

Passive control

NO INTERVENTION

Children in this condition will not attend a summer program.

Interventions

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.

Healthy Summer Learners

21st Century Summer Learning Center BEHAVIORAL

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

21st Century Learning Center

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• children with severe intellectual or physical disabilities

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29205, United States

Location

Related Publications (2)

• 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.

  PMID: 35339766 DERIVED

• 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.

  PMID: 32514369 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: R. Glenn Weaver
• Organization: University of South Carolina

weaverrg@email.edu

803-777-5606

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: October 25, 2017
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2021
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)