Trial Outcomes & Findings for Preventing Weight Gain and Unhealthy Behaviors in Children (NCT NCT04608188)
NCT ID: NCT04608188
Last Updated: 2024-08-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
End of school year (start of summer - baseline), beginning of the following school year (3 month)
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
68
|
|
Overall Study
COMPLETED
|
17
|
60
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
Baseline Characteristics
Preventing Weight Gain and Unhealthy Behaviors in Children
Baseline characteristics by cohort
| Measure |
Summer Program
n=21 Participants
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.
|
No Program
n=68 Participants
The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.5 Years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
8.4 Years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
8.4 Years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
68 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
BMI z-score
|
0.61 z-score
STANDARD_DEVIATION 1.28 • n=5 Participants
|
0.91 z-score
STANDARD_DEVIATION 1.36 • n=7 Participants
|
0.84 z-score
STANDARD_DEVIATION 1.33 • n=5 Participants
|
|
Inhibit BRIEF Subscale
|
55.8 t-score
STANDARD_DEVIATION 16 • n=5 Participants
|
53.7 t-score
STANDARD_DEVIATION 11.9 • n=7 Participants
|
54.3 t-score
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Monitor BRIEF Subscale
|
53.6 t-score
STANDARD_DEVIATION 13.8 • n=5 Participants
|
52.7 t-score
STANDARD_DEVIATION 11.3 • n=7 Participants
|
52.9 t-score
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Emotional Control BRIEF Subscale
|
56.8 t-score
STANDARD_DEVIATION 17.1 • n=5 Participants
|
55.0 t-score
STANDARD_DEVIATION 14.1 • n=7 Participants
|
55.4 t-score
STANDARD_DEVIATION 14.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Summer Program
n=21 Participants
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.
|
No Program
n=68 Participants
The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would.
|
|---|---|---|
|
Change in Body Mass Index Z-score
|
0.04 z-score
Standard Error 0.572466
|
-0.14 z-score
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Summer Program
n=21 Participants
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.
|
No Program
n=68 Participants
The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would.
|
|---|---|---|
|
Change in Inhibit BRIEF Subscale
|
6.0 t-score
Standard Error 5.8
|
2.3 t-score
Standard Error 5.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Summer Program
n=21 Participants
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.
|
No Program
n=68 Participants
The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would.
|
|---|---|---|
|
Change in Monitor BRIEF Subscale
|
8.6 t-score
Standard Error 5.5
|
6.6 t-score
Standard Error 6.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Summer Program
n=21 Participants
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.
|
No Program
n=68 Participants
The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would.
|
|---|---|---|
|
Change in Emotional Control BRIEF Subscale
|
-0.44 t-score
Standard Error 6.9
|
0.36 t-score
Standard Error 7.3
|
Adverse Events
Summer Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place