Preventing Weight Gain and Unhealthy Behaviors in Children

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608188
• Other study ID #: Pro00091526
• Status: Completed
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 30, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Gain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)