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This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households.
Evidence suggests that components within structured days (e.g., school days) have a positive influence on children's obesogenic behaviors (i.e., diet, sleep, physical activity, sedentary behaviors) and self-regulation. In this pilot study children will be randomized to two arms: attend a structured summer camp, not attend a camp. The investigators hypothesize that children attending the summer camp will engage in more healthy obesogenic behaviors, display higher levels of self-regulation, and subsequently will experience less weight gain than children not attending the summer camp. To test this hypothesis the following specific aims will be accomplished: Aim 1 (Primary): Compare changes in BMI z-scores and fitness among children from low-income households attending a structured summer day camp and those not attending a structured summer day camp. Aim 2 (Secondary): Compare changes in obesogenic behaviors among children attending a structured summer day camp and those not attending a structured summer day camp. Aim 3 (Exploratory): Explore changes in self-regulation and the moderating effect of these changes on primary and secondary outcomes among children attending and not attending a structured summer day camp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Summer Program | Experimental | Children in the intervention will attend a summer day camp operated at their school. |
|
| No Program | No Intervention | The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Summer Camp | Behavioral | The intervention camps will operate according to routine practice, with no assistance from the investigative team. 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. All camp meals will adhere to the United States Department of Agriculture Summer Food Service Program nutrition guidelines. The camps employ 1 staff member for every 12 children - which is consistent with childcare regulations in the state of operation and operate daily (Mon-Fri) for 8 weeks during the summer. The camps open at 7am and close 6 pm daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index 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 | End of school year (start of summer - baseline), beginning of the following school year (3 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inhibit BRIEF Subscale | The Behavior Rating Inventory of Executive Function was developed to provide a window into the everyday behavior associated with specific domains of the executive functions. This can be described as the ability to resist impulses and the ability to stop one's own behavior at the appropriate time. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37189190 | Derived | Weaver RG, Armstrong B, Adams E, Beets MW, White J, Flory K, Wilson D, McLain A, Tennie B. Feasibility and preliminary efficacy of structured programming and a parent intervention to mitigate accelerated summer BMI gain: a pilot study. Pilot Feasibility Stud. 2023 May 15;9(1):83. doi: 10.1186/s40814-023-01312-3. | |
| 35378750 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Summer Program | Children in the intervention will attend a summer day camp operated at their school. Summer Camp: The intervention camps will operate according to routine practice, with no assistance from the investigative team. 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. All camp meals will adhere to the United States Department of Agriculture Summer Food Service Program nutrition guidelines. The camps employ 1 staff member for every 12 children - which is consistent with childcare regulations in the state of operation and operate daily (Mon-Fri) for 8 weeks during the summer. The camps open at 7am and close 6 pm daily. |
| FG001 | No Program | The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Summer Program | Children in the intervention will attend a summer day camp operated at their school. Summer Camp: The intervention camps will operate according to routine practice, with no assistance from the investigative team. 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. All camp meals will adhere to the United States Department of Agriculture Summer Food Service Program nutrition guidelines. The camps employ 1 staff member for every 12 children - which is consistent with childcare regulations in the state of operation and operate daily (Mon-Fri) for 8 weeks during the summer. The camps open at 7am and close 6 pm daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Mass Index 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 | Posted | Mean | Standard Error | z-score | End of school year (start of summer - baseline), beginning of the following school year (3 month) |
|
Data were collected for the 1 year that the participants were enrolled in the study.
The participants were healthy children
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Summer Program | Children in the intervention will attend a summer day camp operated at their school. Summer Camp: The intervention camps will operate according to routine practice, with no assistance from the investigative team. 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. All camp meals will adhere to the United States Department of Agriculture Summer Food Service Program nutrition guidelines. The camps employ 1 staff member for every 12 children - which is consistent with childcare regulations in the state of operation and operate daily (Mon-Fri) for 8 weeks during the summer. The camps open at 7am and close 6 pm daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Weaver | University of South Carolina | 8037775605 | weaverrg@mailbox.sc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2019 | Aug 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2019 | Aug 12, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2019 | Aug 14, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| End of school year (start of summer - baseline), beginning of the following school year (3 month) |
| Change in Monitor BRIEF Subscale | The Behavior Rating Inventory of Executive Function measures Task-oriented monitoring or work-checking habits and Self-monitoring or interpersonal awareness. The task monitoring portion of the scale captures whether a child assesses his or her own performance during tasks to ensure accuracy. The self-monitoring portion of the scale evaluates whether a child keeps track of the effect that his or her behavior has on others. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. | End of school year (start of summer - baseline), beginning of the following school year (3 month) |
| Change in Emotional Control BRIEF Subscale | The Behavior Rating Inventory of Executive Function measures The Emotional Control scale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. | End of school year (start of summer - baseline), beginning of the following school year (3 month) |
| Weaver RG, Armstrong B, Adams E, Beets M, White J, Flory K, Wilson D, Mclain A, Tennie B. Feasibility & Preliminary Efficacy of Structured Programming and a Parent Intervention to Mitigate Accelerated Summer BMI Gain: A pilot study. Res Sq [Preprint]. 2022 Mar 29:rs.3.rs-1466063. doi: 10.21203/rs.3.rs-1466063/v1. |
| BG001 | No Program | The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI z-score | 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 | Mean | Standard Deviation | z-score |
|
| Inhibit BRIEF Subscale | The Behavior Rating Inventory of Executive Function was developed to provide a window into the everyday behavior associated with specific domains of the executive functions. This can be described as the ability to resist impulses and the ability to stop one's own behavior at the appropriate time. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. | Mean | Standard Deviation | t-score |
|
| Monitor BRIEF Subscale | The Behavior Rating Inventory of Executive Function measures Task-oriented monitoring or work-checking habits and Self-monitoring or interpersonal awareness. The task monitoring portion of the scale captures whether a child assesses his or her own performance during tasks to ensure accuracy. The self-monitoring portion of the scale evaluates whether a child keeps track of the effect that his or her behavior has on others. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. | Mean | Standard Deviation | t-score |
|
| Emotional Control BRIEF Subscale | The Behavior Rating Inventory of Executive Function measures The Emotional Control scale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. | Mean | Standard Deviation | t-score |
|
| OG001 | No Program | The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would. |
|
|
|
| Secondary | Change in Inhibit BRIEF Subscale | The Behavior Rating Inventory of Executive Function was developed to provide a window into the everyday behavior associated with specific domains of the executive functions. This can be described as the ability to resist impulses and the ability to stop one's own behavior at the appropriate time. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. | Posted | Mean | Standard Error | t-score | End of school year (start of summer - baseline), beginning of the following school year (3 month) |
|
|
|
|
| Secondary | Change in Monitor BRIEF Subscale | The Behavior Rating Inventory of Executive Function measures Task-oriented monitoring or work-checking habits and Self-monitoring or interpersonal awareness. The task monitoring portion of the scale captures whether a child assesses his or her own performance during tasks to ensure accuracy. The self-monitoring portion of the scale evaluates whether a child keeps track of the effect that his or her behavior has on others. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. | Posted | Mean | Standard Error | t-score | End of school year (start of summer - baseline), beginning of the following school year (3 month) |
|
|
|
|
| Secondary | Change in Emotional Control BRIEF Subscale | The Behavior Rating Inventory of Executive Function measures The Emotional Control scale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome. | Posted | Mean | Standard Error | t-score | End of school year (start of summer - baseline), beginning of the following school year (3 month) |
|
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|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | No Program | The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would. | 0 | 68 | 0 | 68 | 0 | 68 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |