Determining the Optimal Amount of Structured Environments for Healthy Kids (DOSE)

Identifying the Ideal Dose of Structured Summer Programming for Mitigating Accelerated Summer BMI Gain

Studies show that virtually all increases in children's (5-12yrs) BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Recent preliminary studies show that children engage in healthier behaviors on days that they attend summer day camps, and that BMI gain does not accelerate for these children. The proposed randomized dose-response study will identify the dose-response relationship between amount of summer programming and summer BMI gain.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Obesity; Socioeconomic Factors; Health Status Disparities; Ethnic Groups
• Intervention / Treatment: Behavioral: Summer day camp

Detailed Description

Summer is a period of accelerated BMI gain for children (5-12yrs). Studies show that virtually all increases in BMI occur during the summer, no matter children's' weight status (i.e., normal weight, overweight, or obese) at summer entry. Our research team recently developed the Structured Days Hypothesis (SDH), which may explain accelerated summer BMI gain. The SDH posits that structure, defined as pre-planned, segmented, and adult-supervised compulsory environments, protect children against obesogenic behaviors and prevent excessive BMI gain. The SDH draws upon the 'filled-time perspective', which posits that time filled with favorable activities cannot be filled with unfavorable activities. In the context of the SDH, this means that children engage in more obesogenic behaviors that lead to increased weight gain during times that are less-structured (e.g., summer days) compared to times that are more structured (e.g., school days). Based on the SDH, pre-existing community-operated summer day camps (e.g., B&G Club, YMCA), may exert a positive influence on summer BMI gain by limiting children's engagement in obesogenic behaviors. Recent preliminary studies show that children engage in healthier behaviors on days that they attend summer day camps, and that BMI gain does not accelerate for these children. A major weakness in the rigor of these preliminary studies is that they cannot identify the dose-response relationship between structured summer programming and summer BMI gain. Dose-response studies can definitively identify the smallest dose at which a useful effect is observed while simultaneously revealing the maximum dose beyond which there is no further beneficial effect. In the same way determining the effective dose of structure to mitigate negative health outcomes is necessary to inform feasible, scalable interventions and health policy. The proposed randomized dose-response study will identify the dose-response relationship between amount of summer programming and summer BMI gain. The impact of 4 weeks (n=90, 20 days), 6 weeks (n=90, 30 days), and 8 weeks (n=90, 40 days) of summer programming compared to no program (n=90) will be evaluated. Comprehensive implementation monitoring to evaluate implementation will also be conducted. This will identify factors associated with children's summer BMI gain and obesogenic behaviors. The aims of the study are to: Aim 1. Evaluate structured summer programming's impact on children's BMI gain and obesogenic behaviors. Aim 2. Evaluate implementation and contextual factors and their relationship with children's summer BMI gain and obesogenic behaviors. Aim 3. Determine the cost effectiveness of 4, 6, 8 weeks of summer programming for mitigating accelerated summer BMI gain. This work is significant as it addresses a critical public health goal - reducing obesity - through programing during a timeframe - summer vacation - when substantial, long-lasting negative effects occur. This application is innovative because of the focus on identifying the dose-response relationship between structured summer programming and summer BMI gain. This innovation addresses a weakness in the rigor of previous studies and is critical for identifying the ideal dose of summer programming for mitigating accelerated summer BMI gain.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Robert Weaver; Phone Number: 8037775605; Email: weaverrg@mailbox.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29205
      • Recruiting
      • University of South Carolina
      • Contact: Robert G Weaver; Email: weaverrg@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• k-4th grader in a partner school
• eligible for free and reduced price lunch (a widely recognized indicator of
• socioeconomic level and poverty status)
• parent that indicates "yes' on an informed consent document for participation in the study

Exclusion Criteria:

• Diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol
• a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
• Families who plan to enroll their children in a summer camp or relocate (i.e., move) during the 14-month period that they participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Children in this group will not receive a voucher to attend a pre-existing summer program
Experimental: 4-week voucher; Children in this group will receive a voucher to attend 4-weeks of a pre-existing summer program	Behavioral: Summer day camp; The summer day camp programs are existing camps which take place at schools from which children will be recruited. The camps are not singularly focused, such as sport camps or academic only camps. Rather, the camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks.
Experimental: 6-week voucher; Children in this group will receive a voucher to attend 6-weeks of a pre-existing summer program	Behavioral: Summer day camp; The summer day camp programs are existing camps which take place at schools from which children will be recruited. The camps are not singularly focused, such as sport camps or academic only camps. Rather, the camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks.
Experimental: 8-week voucher; Children in this group will receive a voucher to attend 8-weeks of a pre-existing summer program	Behavioral: Summer day camp; The summer day camp programs are existing camps which take place at schools from which children will be recruited. The camps are not singularly focused, such as sport camps or academic only camps. Rather, the camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index	BMI translated into BMI z-scores based on Centers for Disease Control age-sex-specific zBMI growth charts	End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 months)

Collaborators and Investigators

• Sponsor: University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: Pro00125467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No