Preventing Weight Gain and Unhealthy Behaviors in Children
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Summer Camp
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Summer Program
No Program
Arm Description
Children in the intervention will attend a summer day camp operated at their school.
The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would.
Outcomes
Primary Outcome Measures
Change in Body Mass Index
BMI translated into zBMI (z-scores) based on age-sex-specific zBMI
Secondary Outcome Measures
Change in Self-regulation
Behavior Rating Inventory of Executive Function
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).
Change in Sleep midpoint
Sleep midpoint will be collected via the wrist-placed ActiGraph on the non-dominant hand
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.
Change in Dietary Behavior
Number of healthy and unhealthy foods consumed will be assessed via parent-assisted established dietary screeners
Full Information
NCT ID
NCT04608188
First Posted
October 21, 2020
Last Updated
December 2, 2022
Sponsor
University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT04608188
Brief Title
Preventing Weight Gain and Unhealthy Behaviors in Children
Official Title
An Intervention to Prevent Weight Gain and Unhealthy Behaviors in Children From Economically Disadvantaged Circumstances
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Summer Program
Arm Type
Experimental
Arm Description
Children in the intervention will attend a summer day camp operated at their school.
Arm Title
No Program
Arm Type
No Intervention
Arm Description
The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would.
Intervention Type
Behavioral
Intervention Name(s)
Summer Camp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index
Description
BMI translated into zBMI (z-scores) based on age-sex-specific zBMI
Time Frame
End of school year (start of summer - baseline), beginning (3 month) and end of the following school year (12 month)
Secondary Outcome Measure Information:
Title
Change in Self-regulation
Description
Behavior Rating Inventory of Executive Function
Time Frame
End of school year (start of summer - baseline), beginning (3 month) and end of the following school year (12 month)
Title
Physical activity
Description
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).
Time Frame
Spring during school year (baseline) and during summer (2 month)
Title
Change in Sleep midpoint
Description
Sleep midpoint will be collected via the wrist-placed ActiGraph on the non-dominant hand
Time Frame
Spring during school year (baseline) and during summer (2 month)
Title
Change in Screen Time
Description
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.
Time Frame
Spring during school year (baseline) and during summer (2 month)
Title
Change in Dietary Behavior
Description
Number of healthy and unhealthy foods consumed will be assessed via parent-assisted established dietary screeners
Time Frame
Spring during school year (baseline) and during summer (2 month)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35378750
Citation
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. 2022 Mar 29:rs.3.rs-1466063. doi: 10.21203/rs.3.rs-1466063/v1. Preprint.
Results Reference
derived
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Preventing Weight Gain and Unhealthy Behaviors in Children
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