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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether structured afterschool and summer programs can help address childhood obesity, particularly in low-income children. Researchers believe these programs might protect children from unhealthy behaviors that could lead to excessive weight gain. Participants will attend afterschool programs, summer camps, both, or neither to determine the most effective approach. Children in kindergarten to 4th grade who qualify for free or reduced-price lunch and attend a partner school may be eligible to join. As a Phase 2 trial, this research measures how well these programs work in an initial, smaller group of children, offering participants a chance to benefit from potentially effective interventions.

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 prior data suggests that these programs are safe for children?

Research shows that the Healthy Kids Beyond the Bell program emphasizes community-run afterschool and summer activities. These programs help children maintain a healthy weight by promoting active play and healthier habits.

For safety, studies have found that children generally receive these programs well. They include everyday activities and social interactions, which are safe for most kids. Similar programs have reported no major problems, indicating that this approach is safe for children.

As this is a Phase 2 study, researchers are still assessing the program's safety. Phase 2 studies involve more participants than earlier ones, indicating that researchers have already found the program to be fairly safe in smaller groups. This phase will help confirm the program's safety and effectiveness for more children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Kids Beyond the Bell program because it tackles childhood obesity by integrating physical activity and healthy lifestyle education into children's daily routines. Unlike standard treatments that often focus on diet changes or medical interventions, this program offers a comprehensive approach through after-school activities and summer camps. These programs not only aim to improve physical health but also promote long-term habits by making healthy living a fun and engaging part of kids' everyday lives. By embedding these activities in environments where children naturally spend time, the program could potentially have a more lasting impact than traditional methods.

What evidence suggests that this trial's programs could be effective for childhood obesity?

This trial will evaluate the effectiveness of organized programs outside school hours in preventing obesity in children, especially those from low-income families. Participants may attend after-school programs, summer camps, or both. Studies have shown that attending such programs increases exercise and access to healthier food choices, leading to improvements in weight, such as a healthier Body Mass Index (BMI), which measures body fat based on height and weight. Early research suggests these programs effectively reduce behaviors that lead to obesity. Overall, organized programs offer a promising way to help children maintain a healthier weight. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39449089/

a 2x2 full factorial study evaluating the impact of summer ... Rationale and design of Healthy Kids Beyond the Bell: a 2x2 full factorial study evaluating the impact of summer and after-school programming on ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05880901?titles=beyond%20the%20bell&rank=1

Healthy Kids Beyond the Bell: Investigating the Impact of ... 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 ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08555-2

a 2x2 full factorial study evaluating the impact of summer and ... Therefore, the after-school period may also contribute to higher rates of obesity in children from families with low-income [27]. Summer day ...

4. trialx.com trialx.com/clinical-trials/listings/286351/healthy-kids-beyond-the-bell-investigating-the-impact-of-after-school-and-summer-programs/

Healthy Kids Beyond the Bell: Investigating ... Thus, this study will rigorously test the impact of providing access to existing, community-operated afterschool and summer programs on weight ...

5. researchgate.net researchgate.net/publication/385126254_Rationale_and_design_of_Healthy_Kids_Beyond_the_Bell_A_2x2_full_factorial_study_evaluating_the_impact_of_summer_and_after_school_programming_on_children's_body_mass_index_and_health_behaviors

(PDF) Rationale and design of Healthy Kids Beyond the Bell This study will test the impact of providing vouchers to access existing, community-operated after school and summer programs on BMI z-score, body composition, ...

6. withpower.com withpower.com/trial/phase-2-obesity-2024-54596

After-School and Summer Programs for Childhood Obesity This Phase 2 medical study run by University of South Carolina is evaluating whether Healthy Kids Beyond the Bell will have tolerable side effects ...