Obesity
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALSummer 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.
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index Z-score | End of school year (start of summer - baseline), beginning of the following school year (3 month) | 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 |
|---|---|---|
| Change in Inhibit BRIEF Subscale | End of school year (start of summer - baseline), beginning of the following school year (3 month) | 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. |
| Change in Monitor BRIEF Subscale | End of school year (start of summer - baseline), beginning of the following school year (3 month) | 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. |
| Change in Emotional Control BRIEF Subscale | End of school year (start of summer - baseline), beginning of the following school year (3 month) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 68 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 8 |
Baseline characteristics
| Characteristic | No Program | Total | Summer Program |
|---|---|---|---|
| Age, Continuous | 8.4 Years STANDARD_DEVIATION 1.4 | 8.4 Years STANDARD_DEVIATION 1.5 | 8.5 Years STANDARD_DEVIATION 1.7 |
| BMI z-score | 0.91 z-score STANDARD_DEVIATION 1.36 | 0.84 z-score STANDARD_DEVIATION 1.33 | 0.61 z-score STANDARD_DEVIATION 1.28 |
| Emotional Control BRIEF Subscale | 55.0 t-score STANDARD_DEVIATION 14.1 | 55.4 t-score STANDARD_DEVIATION 14.8 | 56.8 t-score STANDARD_DEVIATION 17.1 |
| Inhibit BRIEF Subscale | 53.7 t-score STANDARD_DEVIATION 11.9 | 54.3 t-score STANDARD_DEVIATION 12.9 | 55.8 t-score STANDARD_DEVIATION 16 |
| Monitor BRIEF Subscale | 52.7 t-score STANDARD_DEVIATION 11.3 | 52.9 t-score STANDARD_DEVIATION 11.9 | 53.6 t-score STANDARD_DEVIATION 13.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 49 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 40 Participants | 9 Participants |
| Region of Enrollment United States | 68 participants | 89 participants | 21 participants |
| Sex: Female, Male Female | 30 Participants | 41 Participants | 11 Participants |
| Sex: Female, Male Male | 38 Participants | 48 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 68 |
| other Total, other adverse events | 0 / 21 | 0 / 68 |
| serious Total, serious adverse events | 0 / 21 | 0 / 68 |
Outcome results
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
Time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Summer Program | Change in Body Mass Index Z-score | 0.04 z-score | Standard Error 0.572466 |
| No Program | Change in Body Mass Index Z-score | -0.14 z-score | Standard Error 0.09 |
p-value: 0.05Mixed Models Analysis
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.
Time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Summer Program | Change in Emotional Control BRIEF Subscale | -0.44 t-score | Standard Error 6.9 |
| No Program | Change in Emotional Control BRIEF Subscale | 0.36 t-score | Standard Error 7.3 |
p-value: 0.05Mixed Models Analysis
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.
Time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Summer Program | Change in Inhibit BRIEF Subscale | 6.0 t-score | Standard Error 5.8 |
| No Program | Change in Inhibit BRIEF Subscale | 2.3 t-score | Standard Error 5.6 |
p-value: 0.05Mixed Models Analysis
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.
Time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Summer Program | Change in Monitor BRIEF Subscale | 8.6 t-score | Standard Error 5.5 |
| No Program | Change in Monitor BRIEF Subscale | 6.6 t-score | Standard Error 6 |
p-value: 0.05Mixed Models Analysis