Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05880901
Other study ID # Pro00125471
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2024
Est. completion date August 31, 2028

Study information

Verified date March 2024
Source University of South Carolina
Contact Robert Weaver
Phone 8037775605
Email weaverrg@mailbox.sc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nearly one in five children are obese, and disparities in overweight and obesity between children from low- and middle-to-high-income households persist despite a multitude of school-based interventions. The structured days hypothesis posits that structure within a school day plays a protective role for children against obesogenic behaviors, and, ultimately, prevents the occurrence of excessive weight gain, thus, past school-based efforts are misplaced. This study will provide access to healthy structured programming via vouchers to afterschool programs and summer day camps during two "windows of vulnerability" (ie afterschool and summer) for low-income children.


Description:

Despite the public health field's best efforts, disparities in overweight and obesity (OWOB) prevalence between children (6-11) from low- and middle-to-high-income families persist. Previous interventions to address disparate rates of childhood OWOB have focused almost exclusively on school settings. Given that disparities in OWOB persist, current school-based efforts may be misplaced because children engage in more unhealthy behaviors outside of school (e.g., afterschool during weekdays and during the summer). The structured days hypothesis posits that a structure within a day, defined as a pre-planned, segmented, and adult-supervised compulsory environment (like a school day), plays a protective role for children against obesogenic behaviors, and, ultimately, prevents the occurrence of negative health-outcomes, such as, excessive weight gain. Essentially, the structured days hypothesis draws upon concepts in the 'filled-time perspective' literature which posits that time filled with favorable activities cannot be filled with unfavorable activities. There are at least two "windows of vulnerability" for children outside of the school day. These critically important windows include the hours immediately following school (i.e., 3-6pm school days) and the 10 weeks of summer vacation. Programs that can provide a healthy structured environment and prevent unhealthy weight gains exist for both of these time periods (i.e., afterschool programs and summer day camps). Unfortunately, these programs are too expensive for children from low-income families to attend. Thus, this study will rigorously test the impact of providing access to existing, community-operated afterschool and summer programs on weight status (i.e., BMI z-score) and obesogenic behaviors (i.e., physical activity, screen use, diet, and sleep) of elementary children from low-income households. The study will employ a 2x2 full factorial design. The two factors will be access, through vouchers, to structured programming. The four groups will be a no treatment control, afterschool program voucher only, summer day camp voucher only, and vouchers for afterschool and summer day camp combined. The study will accomplish the following specific aims: AIM 1 (Primary): Compare changes in z-BMI among children in the no treatment control, afterschool only, summer camp only, and afterschool and summer day camp combined groups. AIM 2 (Secondary): Compare differences in obesogenic behaviors during the school year and the summer among children in the no treatment control, school only, summer camp only, and afterschool and summer day camp combined intervention groups. AIM 3 (Secondary): Evaluate the cost-effectiveness of delivering the afterschool only, summer camp only, and combined interventions. This study is significant because nearly one in five children are obese, and disparities in OWOB between children from low- and middle-to-high-income households persist despite past school-based interventions. This study is innovative because it represents one of the first attempts to provide access to healthy structured programming during two "windows of vulnerability" for children outside of the school day. Should the proposed intervention strategy prove effective it has the potential to mitigate disparities in OWOB prevalence.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date August 31, 2028
Est. primary completion date March 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria: - k-4th grader in a partner school - eligible for free and reduced price lunch (a widely recognized indicator of - socioeconomic level and poverty status) - parent that 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 - a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance. - Families who plan to enroll their children in a summer camp or after school program or relocate (i.e., move) during the 14-month period that they participate

Study Design


Intervention

Behavioral:
After school program
The after school program are existing community-based programs that take place immediately after the regular school day (typically 3:00-6:00pm); are located in a school; are available daily throughout the academic year (Monday through Friday); and provide a combination of scheduled activities, which include a snack, homework assistance/tutoring, enrichment activities (e.g., arts and crafts, music), and opportunities for children to be physically active.
Summer day camp
The summer day camp programs are existing camps which take place at schools from which children will be recruited. The camps are not singularly focused, such as sport camps or academic only camps. Rather, 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.

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 BMI z-scores based on Centers for Disease Control age-sex-specific zBMI growth charts End of school year (0 months, start of summer), beginning of school year (3 months, end of summer) and end of following school year (12 months)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT03036696 - The BEACH Interview Study- Pregnant and Breastfeeding Mothers
Not yet recruiting NCT02484612 - Exercise Intensity and Appetite in Adolescents N/A
Completed NCT02959034 - Pediatric Metabolism and Microbiome Repository
Completed NCT02545764 - Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children N/A
Recruiting NCT02426346 - A Scalable Weight Control Intervention for Adolescents Phase 2
Completed NCT02160847 - Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors N/A
Completed NCT01989065 - Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment. N/A
Completed NCT01908153 - Taste Reward Processing in Pediatric Obesity
Completed NCT02343588 - A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity N/A
Completed NCT02375490 - Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres N/A
Completed NCT02074332 - Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing N/A
Completed NCT02086851 - Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program. N/A
Terminated NCT00846521 - Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity Phase 4
Completed NCT01146314 - A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children N/A
Completed NCT04164277 - FirstStep2Health Intervention N/A
Withdrawn NCT04600648 - Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children N/A
Completed NCT04395430 - A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19 N/A
Completed NCT03139877 - Pediatric Obesity Observational Prospective Trial