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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
BNFit Trial Summary
This trial will establish whether an after-school program can help Bronx youth lose weight and reduce their risk of diabetes.
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.Check my eligibility
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.See study design
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.
BNFit Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in BMI
Secondary outcome measures
Change in cardiovascular disease risk
Change in diabetes risk
Change in fitness
+4 moreBNFit 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
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,117 Total Patients Enrolled
4 Trials studying Obesity
10,668 Patients Enrolled for Obesity
Health Resources and Services Administration (HRSA)FED
84 Previous Clinical Trials
151,408 Total Patients Enrolled
4 Trials studying Obesity
1,085 Patients Enrolled for Obesity
Elizabeth Walker, PhD, RNStudy DirectorAlbert Einstein College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Group 3 - Standard of Care
- Group 2: Group 2 - Standard of Care
- Group 3: Group 1 - B'N Fit POWER
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there available openings for enrollees in this clinical experiment?
"According to clinicaltrials.gov, this medical study is not currently accepting participants. Initially posted on June 15th 2017, the trial was last edited February 16th 2022. Nevertheless, there are 330 other ongoing trials searching for volunteers at this moment in time."
Answered by AI
Does this medical study accept individuals past their sixtieth birthday?
"To be included in this particular trial, patients must between the ages of 10 and 14 years old. Furthermore, there are 54 clinical trials for minors and 206 for senior citizens."
Answered by AI
What qualifications must a participant meet in order to be eligible for this experiment?
"This clinical trial is enrolling 150 minors, between the ages of 10 and 14 who are suffering from obesity. Additionally, they must be 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. Moreover, their parent or guardian should remain contactable either by phone or in person during all medical visits."
Answered by AI
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