B'N Fit POWER Program for Youth Obesity

(BNFit Trial)

No longer recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Major mental illness, Medical problems

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called B'N Fit POWER, designed to reduce obesity in children by implementing a weight-loss intervention in a real-world school setting. The goal is to assess the program's effectiveness and its potential for expansion to more schools, particularly in the Bronx. Participants will either join the B'N Fit POWER program or receive standard care for comparison. Children aged 10 to 14 in specific school and afterschool programs in the Bronx may qualify. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative obesity interventions in schools.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the B'N Fit POWER program is safe for youth?

Research has shown that the B'N Fit POWER program helps reduce obesity in children by involving schools and communities. Studies found that 44% of participating children with overweight or obesity either maintained or improved their body fat, as measured by their BMI z-score, which is based on height and weight. While the research highlights the program's impact on weight, it does not specifically mention any safety issues or side effects.

The B'N Fit POWER program includes lifestyle changes and activities that are generally safe. However, as this is a trial, some risks might exist, though they are likely small. Participants can expect changes in diet, exercise, and health education, which are common and usually well-tolerated methods for managing weight. Healthcare professionals will address any specific concerns during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the B'N Fit POWER Program because it offers a fresh approach to tackling youth obesity. Unlike traditional methods that might focus solely on diet or exercise, this program integrates an afterschool component that aims to engage kids in a supportive environment. By fostering healthy habits and providing consistent, structured activities, it could address obesity more holistically. This comprehensive strategy sets it apart from existing treatments and holds promise for creating lasting change in participants' lifestyles.

What evidence suggests that the B'N Fit POWER program is effective for youth obesity?

Research has shown that the B'N Fit POWER program, available to participants in this trial, may help young people manage obesity. One study found that 44% of overweight or obese youth participants either maintained or improved their body fat levels. The program operates in schools and communities, facilitating student participation and retention. It incorporates successful elements from other effective programs in similar contexts. This approach is particularly beneficial for reaching ethnic minority teens, who often face challenges in accessing weight management programs. These early findings suggest that B'N Fit POWER could effectively promote healthier habits in young people. ^{1 6 7 8 9}

Who Is on the Research Team?

Elizabeth Walker, PhD, RN

Principal Investigator

Albert Einstein College of Medicine

Jessica Rieder, MD, MS

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for Bronx youth aged 10-14 who are enrolled in both the Montefiore School Health Program and Mosholu Montefiore Community Center afterschool program at PS/MS 95. They need a parent or guardian available for clinical visits. Those with major mental illness or medical issues that make participation unsafe cannot join.

Inclusion Criteria

Age 10 and no older than 14 when recruited at baseline

A parent or guardian will be available in person or by phone at all clinical visits.

Registered in both the Montefiore School Health Program clinic and Mosholu Montefiore Community Health Center afterschool program at Public School (PS) /Middle School (MS) 95

Exclusion Criteria

Has a major mental illness that would render them incapable of consenting for the research or complying with the B'N Fit POWER afterschool program protocol

Has medical problems that make it unsafe for them to participate in the afterschool program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Intervention

Participants receive the B'N Fit POWER program, which includes weekly leadership sessions and daily physical activity integrated with afterschool programming.

10 months

Daily attendance for afterschool sessions

Follow-up

Participants are monitored for changes in BMI, diabetes risk, cardiovascular disease risk, and other health metrics.

3 months

3 clinic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• B'N Fit POWER

Trial Overview The B'N Fit POWER initiative, a school-based wellness program, is being tested to see if it's feasible and effective in promoting health and reducing diabetes risk among young people by adapting traditional weight-loss interventions to a school setting.

How Is the Trial Designed?

Group I: Group 1 - B'N Fit POWER Experimental Treatment 1 Intervention

Participants enrolling in B'N Fit POWER afterschool program will be assigned to Group 1.

Group II: Group 3 - Standard of Care Active Control 1 Intervention

Participants at an additional school site completing the screening (approximately 100) will be in an additional comparison Group 3.

Group III: Group 2 - Standard of Care Active Control 1 Intervention

All other PS/MS-95 participants who completed the screening (approximately 50) will be in comparison Group 2

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials

88

Recruited

152,000+

Published Research Related to This Trial

The Kids N Fitness program, which included 12 interactive sessions focused on nutrition and exercise, effectively reduced weight and BMI in 264 overweight children aged 7-17, showing better results compared to a 6-month pre-program observation period.

Improvements in emotional well-being and behavior were positively linked to weight loss, indicating that family-centered lifestyle interventions can enhance both physical and psychological health in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a hospital-based, family-centered intervention to reduce weight gain in overweight children and adolescents. Dreimane, D., Safani, D., MacKenzie, M., et al.[2021]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

In a study of 75 participants in the Building Healthy Families program, those who achieved the largest reductions in BMI z-scores had high attendance and self-regulation skills, particularly among both children and mothers.

Successful outcomes were linked to mothers achieving clinically meaningful weight loss and children maintaining high attendance rates, suggesting that both parental involvement and self-regulation are crucial for effective obesity treatment in families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. Golden, CA., Heelan, KA., Hill, JL., et al.[2022]

In a 12-week family-based program called Building Healthy Families, 22 obese children lost an average of 2.3 kg, while their parents lost an average of 6.4 kg, indicating the program's effectiveness in promoting weight loss for both children and parents.

The study found that reducing the intake of high-fat, high-calorie foods was a strong predictor of weight loss in children, highlighting the importance of dietary changes in successful obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. Ruebel, ML., Heelan, KA., Bartee, T., et al.[2019]

The 'Energy Up' program effectively helped inner-city girls lose weight, with obese participants losing an average of 12.9 pounds and overweight participants losing 2.9 pounds over a 9-month period.

The program's focus on avoiding addictive foods, promoting exercise, and building self-esteem contributed to its success, leading to plans for expansion to other schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Energy Up": a novel approach to the weight management of inner-city teens. Chehab, LG., Pfeffer, B., Vargas, I., et al.[2009]

The Parks Rx 4Health(TM) program in Miami-Dade County connects pediatricians with community-based health initiatives, allowing doctors to refer overweight and obese children to an evidence-based afterschool program focused on physical activity and nutrition.

This program collects measurable outcomes like body mass index and fitness levels at baseline and after 3 and 6 months, providing valuable data to track patient progress and support ongoing healthcare efforts against childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing childhood obesity through coordinated care: Development of a park prescription program. Messiah, SE., Jiang, S., Kardys, J., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5903332/

Pilot Project to Integrate Community and Clinical Level ... B'N Fit POWER uses this framework and integrates several elements of successful intensive and school-based obesity prevention and treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3728727/

Evaluation of a Community-Based Weight Management ... The B'N Fit program provides an example of a weight loss program that serves obese, difficult-to-reach, ethnic minority adolescents in a community-based setting ...

3. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-10700-4

Trends in health behavior and weight outcomes following ... Conversely, 44% of youth with overweight or obesity participating in B'N Fit POWER showed either maintenance or improvement in BMI z-score. We ...

4. ctv.veeva.com ctv.veeva.com/study/the-bn-fit-power-initiative-a-school-based-wellness-initiative-for-bronx-youth

The B'N Fit POWER Initiative: A School-Based Wellness ... Although B'N Fit POWER targets youth with overweight and obesity and at high risk for diabetes, it is open to all middle school students at ...

5. researchprotocols.org researchprotocols.org/2020/6/e18098

A Clinical Trial to Increase Self-Monitoring of Physical ... For the study, 80 youths with obesity (aged 13-18 years) and caregiver dyads will be randomized to Brenner FIT or Brenner mFIT. All participants ...

6. researchgate.net researchgate.net/figure/The-BN-Fit-POWER-clinical-and-community-integration-framework-Adapted-from-the_fig1_324038014

The B'N Fit POWER clinical and community integration ... Conclusions: The attainment of several target behaviors among school children linked to the reduction of childhood obesity declined during the COVID-19 pandemic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8028223/

Trends in health behavior and weight outcomes following ... Conversely, 44% of youth with overweight or obesity participating in B'N Fit POWER showed either maintenance or improvement in BMI z-score.

8. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-15267-w

Severe obesity and fitness in New York City public school ... We sought to determine the relationship between increasing weight status and fitness within a sample of children and adolescents from New York City public ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1876285924001657

The Associations between Neighborhood Characteristics ... The odds of child overweight/obesity were highest in neighborhoods reported by parents as being unsafe, unsupportive, having multiple detractions (eg vandalism ...