After-School and Summer Programs for Childhood Obesity

Overseen By Robert Weaver

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of South Carolina

Disqualifiers: Intellectual disability, Physical disability, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

480 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Healthy Kids Beyond the Bell Program for childhood obesity?

Research on similar after-school programs, like Kids Living Fit and Project Healthy Schools, shows that these programs can help reduce obesity in children by promoting healthy eating and physical activity. For example, Kids Living Fit led to a decrease in BMI percentiles and smaller waist circumference increases, while Project Healthy Schools improved health behaviors and physiological measures in students. ^{1 2 3 4 5}

Is the After-School and Summer Programs for Childhood Obesity safe for children?

The available research on similar after-school programs for childhood obesity, like Healthy Kids Out of School and Kids Living Fit, suggests that these programs are generally safe for children. They focus on promoting healthy eating and physical activity, and participants have shown improvements in health measures like body mass index (BMI) and waist circumference without reported safety concerns. ^{1 4 6 7 8}

How is the Healthy Kids Beyond the Bell treatment different from other treatments for childhood obesity?

The Healthy Kids Beyond the Bell treatment is unique because it focuses on after-school and summer programs specifically designed for low-income children, integrating physical activity and nutrition education in a supportive environment. This approach addresses the socioeconomic and environmental factors that contribute to obesity, which are often not the focus of other treatments. ^{1 2 4 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for kids in kindergarten through 4th grade who attend partner schools, qualify for free or reduced-price lunch (indicating lower income), and have a parent's consent. It aims to help children from low-income families who are at risk of obesity by providing structured after-school and summer activities.

Inclusion Criteria

Eligible for free and reduced price lunch (a widely recognized indicator of socioeconomic level and poverty status)

k-4th grader in a partner school

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

I use a wheelchair and cannot walk without help.

I plan to enroll my child in a program or move within the next 14 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

After School Program

Participants attend after school programming for 32 weeks during the school year

32 weeks

Regular attendance during school days

Summer Camp

Participants attend summer day camp programming for 8 weeks during the summer vacation from school

8 weeks

Regular attendance during summer days

Follow-up

Participants are monitored for changes in BMI and obesogenic behaviors

12 months

Treatment Details

Interventions

• Healthy Kids Beyond the Bell

Trial Overview The study tests if giving vouchers for after-school programs and summer day camps can prevent excessive weight gain in children. These programs offer healthy, structured environments during times when kids might otherwise be inactive or have unstructured time.

Participant Groups

Group I: Summer camp Experimental Treatment 1 Intervention

Attends summer day camp programming for 8 weeks during the summer vacation from school

Group II: After school and Summer Camp Experimental Treatment 2 Interventions

Attends after school programming for 32 weeks during the school year and summer day camp programming for 8 weeks during the summer vacation from school

Group III: After school Experimental Treatment 1 Intervention

Attends after school programming for 32 weeks during the school year

Group IV: Control Active Control 1 Intervention

does not attend afterschool or summer programing

Healthy Kids Beyond the Bell is already approved in United States for the following indications:

Approved in United States as Healthy Kids Beyond the Bell for:

• Prevention of excessive weight gain in low-income children

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Findings from Research

The study involved 36 children in intervention groups and 18 in comparison groups, focusing on teaching healthy eating and physical activity through the Traffic Light Diet, which led to improved self-reported eating habits among the children.

While one school saw an increase in physical activity levels, the overall satisfaction from parents and children suggests that after-school programs can effectively promote health education, highlighting the potential role of nurses in implementing such initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an after-school obesity prevention program: helping young children toward improved health. Nabors, L., Burbage, M., Woodson, KD., et al.[2016]

Project Healthy Schools (PHS) has demonstrated significant improvements in health metrics and lifestyle behaviors among middle school students in Michigan, indicating its effectiveness in addressing childhood obesity.

The program's success is linked to collaborative efforts among stakeholders and changes in the school environment, suggesting that such comprehensive approaches can be replicated to combat childhood obesity in other settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top 10 Lessons Learned from Project Healthy Schools. Rogers, R., Krallman, R., Jackson, EA., et al.[2019]

A three-year school-based intervention in a low-income district serving 5,000 children led to a significant decrease in mean BMI percentile from 70.4 to 65.7%, indicating effective weight management among students.

The intervention also resulted in a significant reduction in the number of students categorized as overweight or obese, suggesting that changes in physical activity and nutrition can positively impact childhood obesity rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-Based Obesity Intervention Associated with Three Year Decrease in Student Weight Status in a Low-Income School District. Cadzow, RB., Chambers, MK., Sandell, AM.[2018]

The Kids Living Fit (KLF) after-school program, implemented over 12 weeks with 185 elementary school participants, led to a significant decrease in BMI percentile by 2.3% in the intervention group compared to the no-intervention group.

Participants in the KLF program also experienced a smaller increase in waist circumference, indicating that the program effectively promoted healthier lifestyle choices and may help combat childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of the Kids Living Fit program: a comparative study. Speroni, KG., Earley, C., Atherton, M.[2017]

A survey of 600 parents revealed that a vast majority believe it is important for their children to have access to water (96.2%), fresh fruits and vegetables (79.0%), and physical activity (97.2%) during out-of-school time (OST) programs, although these resources are not consistently available.

Two-thirds of parents support OST programs promoting healthy environments, indicating a strong desire for collaborative efforts between programs and parents to enhance children's nutrition and physical activity, which is crucial for obesity prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent perspectives on nutrition and physical activity during out-of-school time. Anzman-Frasca, S., Newman, MB., Angstrom, HM., et al.[2020]

The Healthy Kids Out of School (HKOS) initiative successfully engaged volunteer-led out-of-school time programs in Maine, Massachusetts, and New Hampshire to promote healthy eating and physical activity among children, using a structured approach that included focus groups and roundtable discussions.

Implementation strategies were tailored to fit the existing practices of the organizations, such as introducing new patch and pin programs for enrichment activities and integrating online training for coaches in sports programs, highlighting the importance of customization in promoting healthy habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Stakeholders From Volunteer-Led Out-of-School Time Programs in the Dissemination of Guiding Principles for Healthy Snacking and Physical Activity. Folta, SC., Koomas, A., Metayer, N., et al.[2018]

The OSNAP intervention significantly improved the quality of written health policies in afterschool programs, with notable increases in standards for snacks, beverages, screen time, and family communication, indicating its effectiveness in promoting healthier environments for children.

The study involved 20 afterschool programs in Boston over a 9-month period, and the assessment of policy changes showed strong reliability and validity, suggesting that structured training can enhance staff capacity to create effective health policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving nutrition and physical activity policies in afterschool programs: results from a group-randomized controlled trial. Kenney, EL., Giles, CM., deBlois, ME., et al.[2022]

A systematic review of 18 studies found that boys are generally more active than girls in Out of School Hours Care (OSHC), and that staff engagement in physical activities and structured programming can positively influence children's activity levels.

To reduce sedentary behavior, it is important to focus on younger children and promote active play while minimizing elimination games, as older children tend to be more sedentary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of physical activity and sedentary behaviour in children attending before and after school care: a systematic review. Woods, AJ., Probst, YC., Norman, J., et al.[2022]

An after-school program targeting overweight children at a Lexington elementary school showed promising trends in slowing weight gain, although results did not reach statistical significance compared to similar demographics.

A significant reduction in mean BMI percentile was observed in the entire school population compared to a comparison school, suggesting that community-based interventions can effectively address childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-driven obesity prevention and intervention in an elementary school. Perman, JA., Young, TL., Stines, E., et al.[2022]

The Youth Fit 4 Life (YF4L) program, implemented in after-school care for 9- to 12-year-olds, led to significant improvements in BMI and various psychosocial factors like self-regulation and self-efficacy over a 9-month period, indicating its effectiveness in combating childhood obesity.

The study found that changes in self-regulation were key mediators in the relationship between the YF4L treatment and BMI reduction, suggesting that enhancing self-management skills can play a crucial role in promoting healthier behaviors among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Youth Fit 4 Life physical activity/nutrition protocol on body mass index, fitness and targeted social cognitive theory variables in 9- to 12-year-olds during after-school care. Annesi, JJ., Walsh, SM., Greenwood, BL., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementation of an after-school obesity prevention program: helping young children toward improved health. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Top 10 Lessons Learned from Project Healthy Schools. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

School-Based Obesity Intervention Associated with Three Year Decrease in Student Weight Status in a Low-Income School District. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of the Kids Living Fit program: a comparative study. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Parent perspectives on nutrition and physical activity during out-of-school time. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Engaging Stakeholders From Volunteer-Led Out-of-School Time Programs in the Dissemination of Guiding Principles for Healthy Snacking and Physical Activity. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Improving nutrition and physical activity policies in afterschool programs: results from a group-randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Correlates of physical activity and sedentary behaviour in children attending before and after school care: a systematic review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A community-driven obesity prevention and intervention in an elementary school. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Effects of the Youth Fit 4 Life physical activity/nutrition protocol on body mass index, fitness and targeted social cognitive theory variables in 9- to 12-year-olds during after-school care. [2018]