Preventing Weight Gain and Unhealthy Behaviors in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Intervention to Prevent Weight Gain and Unhealthy Behaviors in Children From Economically Disadvantaged Circumstances

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Summer Camp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants will be boys and girls that attend one of the participating schools 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 and/or a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance. children who plan to enroll in a summer camp during the year that they participate in the study will also be excluded from the study. No other exclusion criteria will be used.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Summer Program<br>Children in the intervention will attend a summer day camp operated at their school. | Behavioral: Summer Camp<br>* 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.<br>|
| No Intervention: No Program<br>The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index | BMI translated into zBMI (z-scores) based on age-sex-specific zBMI | End of school year (start of summer - baseline), beginning (3 month) and end of the following school year (12 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-regulation | Behavior Rating Inventory of Executive Function | End of school year (start of summer - baseline), beginning (3 month) and end of the following school year (12 month) | 
| Physical activity | Time (minutes per day) spent in sedentary, light, moderate, and vigorous physical activity will be collected using a wrist-placed ActiGraph Link on the non-dominant hand for 9 days (a common timeframe to collect a minimum of 4 to 7 valid days). | Spring during school year (baseline) and during summer (2 month) | 
| Change in Sleep midpoint | Sleep midpoint will be collected via the wrist-placed ActiGraph on the non-dominant hand | Spring during school year (baseline) and during summer (2 month) | 
| Change in Screen Time | Child screen time (minutes per day) will be assessed using a parent-proxy self-report measure completed daily for 9 days by the parent with their child. | Spring during school year (baseline) and during summer (2 month) | 
| Change in Dietary Behavior | Number of healthy and unhealthy foods consumed will be assessed via parent-assisted established dietary screeners | Spring during school year (baseline) and during summer (2 month) |