What side effects are associated with this type of intervention?

Common treatments for obesity, particularly those suitable for school-based programs like B'N Fit POWER, primarily involve lifestyle interventions such as diet and exercise modifications. These interventions generally have minimal side effects, which may include temporary discomfort, muscle soreness, or fatigue. Pharmacotherapy options, such as phentermine-topiramate, can have more significant side effects including increased heart rate, insomnia, dry mouth, constipation, and mood changes. However, lifestyle interventions are typically preferred in school settings due to their safety and feasibility.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including phentermine-topiramate, orlistat, and semaglutide. Phentermine-topiramate has shown significant weight loss in clinical trials, with a mean reduction of 8-10% of baseline body weight. Orlistat works by inhibiting fat absorption and has been associated with modest weight loss. Semaglutide, a GLP-1 receptor agonist, has demonstrated substantial weight loss in trials, with participants losing up to 10.9% of their baseline body weight. These medications, combined with lifestyle interventions, could be adapted for school-based wellness programs like B'N Fit POWER to promote health and reduce diabetes risk among youth.

What other types of research exist?

Promising alternatives to the B'N Fit POWER program for obesity treatment in school settings include: 1) The modified Diabetes Prevention Program (DPP) adapted for adolescents, which has shown significant reductions in BMI and waist circumference. 2) The Fit for Performance curriculum, which has demonstrated success in weight loss and BMI reduction among participants. 3) The Healthy Harlem's Get Fit program, an after-school intervention that has effectively reduced BMI z-scores and obesity rates. 4) The B.E. S.T.R.O.N.G. program, a family-based multidisciplinary approach using an Internet-based health tracker, which has shown positive outcomes in weight management.

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B'N Fit POWER Program for Youth Obesity (BNFit Trial)

N/A

Waitlist Available

Led By Jessica Rieder, MD, MS

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 - 13 months (final visit)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves lifestyle changes rather than medication, typical side effects associated with drugs are not expected. However, participants may experience fatigue or muscle soreness from increased physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 - 13 months (final visit)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 - 13 months (final visit)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 - 13 months (final visit) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in BMI

Secondary study objectives

Change in cardiovascular disease risk

Change in diabetes risk

Change in fitness

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 - B'N Fit POWERExperimental Treatment1 Intervention

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

Group II: Group 3 - Standard of CareActive Control1 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 CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

B'N Fit POWER

2017

N/A

~80

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include lifestyle modifications, cognitive-behavioral therapy (CBT), and pharmacologic agents. Lifestyle modifications focus on improving diet and increasing physical activity, which help reduce caloric intake and increase energy expenditure, leading to weight loss. CBT addresses unhealthy eating behaviors and thought patterns, helping patients develop healthier habits and improve their relationship with food. Pharmacologic agents, such as GLP-1 receptor agonists, work by reducing appetite and increasing feelings of fullness. These treatments are crucial for obesity patients as they not only promote weight loss but also reduce the risk of comorbidities like diabetes, enhancing overall health and quality of life.

A pilot open-label feasibility trial examining an adjunctive mindfulness intervention for adolescents with obesity.Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.Effects of a cognitive-behaviorally based physical activity treatment for 4- and 5-year-old children attending US preschools.