B'N Fit POWER Program for Youth Obesity

(BNFit Trial)

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

79 Participants Needed

Trial Summary

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 data supports the effectiveness of the B'N Fit POWER treatment for youth obesity?

Research on similar programs shows that comprehensive approaches involving nutrition education, physical activity, and behavior modification can lead to significant weight loss in children. For example, a school-based program helped 95% of participating children lose weight, and a family-based program showed that children lost an average of 2.3 kg over 12 weeks. ^{1 2 3 4 5}

Is the B'N Fit POWER Program for Youth Obesity safe for participants?

The studies reviewed focus on family-based lifestyle programs for managing obesity in children, which include nutrition education, physical activity, and behavioral strategies. These programs have shown benefits in weight management and healthier lifestyles without reported safety concerns, suggesting they are generally safe for participants. ^{4 5 6 7 8}

How is the B'N Fit POWER treatment for youth obesity different from other treatments?

The B'N Fit POWER program is unique because it focuses on increasing daily physical activity among middle school students, especially in areas with structural barriers like the Bronx. Unlike other treatments, it adapts to challenges such as the COVID-19 pandemic by addressing food insecurity and the suspension of organized activities, aiming to help children reduce obesity risk through community-based efforts. ^{2 6 9 10 11}

What is the purpose of this trial?

This trial tests B'N Fit POWER, a wellness program for Bronx youth at high risk for diabetes. It promotes healthy habits like eating well and exercising by involving schools, health clinics, and afterschool programs. The goal is to help kids develop good habits and build resilience.

Research Team

Elizabeth Walker, PhD, RN

Principal Investigator

Albert Einstein College of Medicine

Jessica Rieder, MD, MS

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

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

Long-term evaluation of multi-disciplinary treatment of morbid obesity in low-income minority adolescents: La Rabida Children's Hospital's FitMatters program. [2009]

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

"Energy Up": a novel approach to the weight management of inner-city teens. [2009]

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

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

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

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. [2019]

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

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. [2022]

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

Kids N Fitness Junior: Outcomes of an Evidence-Based Adapted Weight Management Program for Children Ages Three-Seven Years. [2023]

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

Park-based obesity intervention program for inner-city minority children. [2015]

8. Ireland pubmed.ncbi.nlm.nih.gov

Feasibility of a hospital-based, family-centered intervention to reduce weight gain in overweight children and adolescents. [2021]

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

Trends in health behavior at an afterschool program: the impact of COVID-19 on students' behavior. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effects of an afterschool community center physical activity program on fitness and body composition in obese youth. [2017]

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

Reducing childhood obesity through coordinated care: Development of a park prescription program. [2020]