Preventing Weight Gain and Unhealthy Behaviors in Children

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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Summer Camp

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29205
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Summer Program; Children in the intervention will attend a summer day camp operated at their school.	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.
No Intervention: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of South Carolina

Publications and helpful links

General Publications

• 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. pii: rs.3.rs-1466063. doi: 10.21203/rs.3.rs-1466063/v1.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: Pro00091526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No