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The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth (BNFit)

Primary Purpose

Overweight and Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
B'N Fit POWER
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity focused on measuring obesity, adolescents, school-based, weight management, wellness

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • PS-95

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Group 1 - B'N Fit POWER

Group 2 - Standard of Care

Group 3 - Standard of Care

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in BMI
height (in m) and weight (in kg) will be combined to report BMI in kg/m^2. Visit schedule: Time 1) Baseline June screen; Time 2) 1st clinic visit from Sept. - Dec.; Time 3) 2nd clinic visit from Jan.-March; Time 4) 3rd clinic visit from April-May; Time 5) Final June screen

Secondary Outcome Measures

Change in cardiovascular disease risk
(LDL-cholesterol, triglycerides, and HDL-cholesterol will be measured). Visit schedule: Time 2) 1st clinic visit from Sept. - Dec.; Time 4) third and final clinic visit from April-May
Change in diabetes risk
HgBA1C will be measured as a marker of insulin resistance. Visit schedule: Time 2) 1st clinic visit from Sept. - Dec.; Time 4) third and final clinic visit from April-May
Change in nutrition and physical activity knowledge
B'N Fit Survey includes questions assessing nutrition and physical activity knowledge. Visit schedule: Time 1) Baseline June screen; Time 5) Final June screen
Change in school attendance and performance
B'N Fit Survey includes questions assessing school attendance and performance.Visit schedule: Time 1) Baseline June screen; Time 5) Final June screen
Change in target behaviors
Target behavior survey assesses number of daily fruit, vegetable, sugar-free beverage, and sugary beverage servings consumed, daily hours of sleep, number of hours of physical activity on a weekly basis, number of days that breakfast and lunch are eaten daily, number of days that fast food and unhealthy snacks are consumed. Visit schedule: Time 1) Baseline June screen; Time 2) 1st clinic visit from Sept. - Dec.; Time 3) 2nd clinic visit from Jan.-March; Time 4) 3rd clinic visit from April-May; Time 5) Final June screen
Change in fitness
Fitness will be assessed by measuring cardiovascular fitness, abdominal strength, trunk strength, arm strength and flexibility by the routinely collected NYC FITNESSGRAM. Visit schedule: Time 1) Baseline June screen; Time 5) Final June screen
Program attendance
Attendance at clinic sessions and afterschool program sessions. Visit Schedule: 1) 1st fall clinic visit (Time 2); 2) 2nd winter clinic visit (Time 3); 3) 3rd spring clinic visit (Time 4) ; 4) Daily attendance for 10 months that afterschool is in session

Full Information

First Posted
May 2, 2018
Last Updated
March 3, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03565744
Brief Title
The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth
Acronym
BNFit
Official Title
The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The findings of this study will establish the feasibility and efficacy of B'N Fit POWER and given the wide presence of MSHP, MMCC and other afterschool programs, there is significant potential for dissemination of B'N Fit POWER to many other clinic-community partnership sites enabling the development of a larger grant that will test the effectiveness and dissemination process to several schools in the Bronx. The translation of a traditional clinical-based weight-loss intervention to adapting and implementing such an intervention in a real-world school setting is more relevant and sustainable for advancing a culture of health and promoting diabetes risk reduction in Bronx youth.
Detailed Description
In this proposal, the investigators aim to test a school-based intervention to promote resilience and prevent obesity related co-morbidities for impoverished racial/ethnic minority Bronx youth who are at increased risk for diabetes. B'N Fit POWER is a wellness program that integrates existing school wellness promotion activities, the Montefiore School Health Program (MSHP) - a network of school-based health clinics, and the Mosholu Montefiore Community Center (MMCC) - a network of afterschool programming, to promote health and build on the resilience of the adolescents. It offers culturally-relevant guidance related to the attainment of 7 Target Behaviors, namely to increase fruit, vegetable and sugar-free beverage intake, obtain adequate sleep, daily physical activity, eating breakfast and lunch daily, and limiting fast food and unhealthy snacks. 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 the school, via community-led recruitment efforts to reduce obesity-related stigma by promoting wellness and fitness. Grounded in Youth Development (YD) Theory and using the principles of Community Based Participatory Research (CBPR) the program integrates patient, family, clinical, and community linkages, and targets individual behaviors as well as the school environment to address environmental and structural barriers to behavioral change. YD program elements are incorporated to build positive identity, youth resilience, and foster youth leadership by having youth contribute to planning community activities with incentives to promote attendance and retention. The investigators will conduct a quasi-experimental trial of B'N Fit POWER and will compare participants receiving B'N Fit POWER (Group 1) to two comparison groups: one from the same school receiving standard of care (Group 2) and, to assess the external validity of Group 2 in terms of characteristics and outcomes, an additional group from another school also receiving standard of care (Group 3) to address the following specific aims: 1) Determine whether B' N Fit POWER is effective in improving fitness, healthy weight attainment, and 7 target behaviors; 2) To assess the impact of moving the B'N Fit program into a school setting on participant engagement; and 3) To assess the mediating pathways associated with program effects. Following an initial health screening, participants enrolling in B'N Fit POWER (Group 1) will receive comprehensive medical assessments at the MSHP integrated with MMCC afterschool programming that incorporates a curriculum focusing on 7 Target Behaviors during weekly leadership sessions and daily physical activity. The comparison groups receive the standard of care (standard MSHP and MMCC afterschool program). Effects of the program will be evaluated using data routinely collected at the schools (e.g. anthropometrics and labs from clinic and the school fitnessgram, attendance, grades) and surveys. Multivariate logistic regressions and mixed-effects linear models will assess program effects for categorical or continuous outcomes and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) approach will identify barriers and solutions to implementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
obesity, adolescents, school-based, weight management, wellness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will conduct a quasi-experimental trial of B'N Fit POWER in two middle schools that have both an onsite MSHP and MMCC service.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - B'N Fit POWER
Arm Type
Experimental
Arm Description
Participants enrolling in B'N Fit POWER afterschool program will be assigned to Group 1.
Arm Title
Group 2 - Standard of Care
Arm Type
No Intervention
Arm Description
All other PS/MS-95 participants who completed the screening (approximately 50) will be in comparison Group 2
Arm Title
Group 3 - Standard of Care
Arm Type
No Intervention
Arm Description
Participants at an additional school site completing the screening (approximately 100) will be in an additional comparison Group 3.
Intervention Type
Behavioral
Intervention Name(s)
B'N Fit POWER
Intervention Description
Participants will undergo a medical assessment and using an Electronic Medical Record (EMR) template, providers will screen for a healthy weight and the 7 target behaviors. Participants will set goals with the provider to attain one of the target behaviors and will receive an EMR-generated treatment plan summarizing healthy weight and target behavior goals. At 20-minute follow-up visits during the school day, the provider will review weight and target behavior attainment and monitor co-morbidities and barriers to participation. Group 1 participants will also have access to daily MMCC afterschool programming from 3-6pm from September through May each year with tailored programming including weekly core nutrition, behavior, and cooking classes and at least five hours of physical activity.
Primary Outcome Measure Information:
Title
Change in BMI
Description
height (in m) and weight (in kg) will be combined to report BMI in kg/m^2. Visit schedule: Time 1) Baseline June screen; Time 2) 1st clinic visit from Sept. - Dec.; Time 3) 2nd clinic visit from Jan.-March; Time 4) 3rd clinic visit from April-May; Time 5) Final June screen
Time Frame
baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
Secondary Outcome Measure Information:
Title
Change in cardiovascular disease risk
Description
(LDL-cholesterol, triglycerides, and HDL-cholesterol will be measured). Visit schedule: Time 2) 1st clinic visit from Sept. - Dec.; Time 4) third and final clinic visit from April-May
Time Frame
4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
Title
Change in diabetes risk
Description
HgBA1C will be measured as a marker of insulin resistance. Visit schedule: Time 2) 1st clinic visit from Sept. - Dec.; Time 4) third and final clinic visit from April-May
Time Frame
4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
Title
Change in nutrition and physical activity knowledge
Description
B'N Fit Survey includes questions assessing nutrition and physical activity knowledge. Visit schedule: Time 1) Baseline June screen; Time 5) Final June screen
Time Frame
baseline, 12 - 13 months (final visit)
Title
Change in school attendance and performance
Description
B'N Fit Survey includes questions assessing school attendance and performance.Visit schedule: Time 1) Baseline June screen; Time 5) Final June screen
Time Frame
baseline, 12 - 13 months (final visit)
Title
Change in target behaviors
Description
Target behavior survey assesses number of daily fruit, vegetable, sugar-free beverage, and sugary beverage servings consumed, daily hours of sleep, number of hours of physical activity on a weekly basis, number of days that breakfast and lunch are eaten daily, number of days that fast food and unhealthy snacks are consumed. Visit schedule: Time 1) Baseline June screen; Time 2) 1st clinic visit from Sept. - Dec.; Time 3) 2nd clinic visit from Jan.-March; Time 4) 3rd clinic visit from April-May; Time 5) Final June screen
Time Frame
Time Frame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
Title
Change in fitness
Description
Fitness will be assessed by measuring cardiovascular fitness, abdominal strength, trunk strength, arm strength and flexibility by the routinely collected NYC FITNESSGRAM. Visit schedule: Time 1) Baseline June screen; Time 5) Final June screen
Time Frame
baseline, 12 - 13 months (final visit)
Title
Program attendance
Description
Attendance at clinic sessions and afterschool program sessions. Visit Schedule: 1) 1st fall clinic visit (Time 2); 2) 2nd winter clinic visit (Time 3); 3) 3rd spring clinic visit (Time 4) ; 4) Daily attendance for 10 months that afterschool is in session
Time Frame
Clinic attendance: 4 -7 months, 8 - 10 months, 11 - 12 months; Afterschool attendance: 4-13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Walker, PhD, RN
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jessica Rieder, MD, MS
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
PS-95
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29850232
Citation
Rieder J, Cain A, Carson E, Benya A, Meissner P, Isasi CR, Wylie-Rosett J, Hoffman N, Kelly C, Silver EJ, Bauman LJ. Pilot Project to Integrate Community and Clinical Level Systems to Address Health Disparities in the Prevention and Treatment of Obesity among Ethnic Minority Inner-City Middle School Students: Lessons Learned. J Obes. 2018 Mar 26;2018:6983936. doi: 10.1155/2018/6983936. eCollection 2018.
Results Reference
result
PubMed Identifier
33827501
Citation
Rieder J, Moon JY, Joels J, Shankar V, Meissner P, Johnson-Knox E, Frohlich B, Davies S, Wylie-Rosett J. Trends in health behavior and weight outcomes following enhanced afterschool programming participation. BMC Public Health. 2021 Apr 7;21(1):672. doi: 10.1186/s12889-021-10700-4.
Results Reference
result

Learn more about this trial

The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth

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