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

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.
Brief Title
The B'N Fit POWER Initiative: A School-Based Wellness Initiative for 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.
Completion Date
Completion Date Type
Actual
Conditions
Overweight and Obesity
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.
Inclusion 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

Gender
All
Gender Based
false
Keywords
obesity
adolescents
school-based
weight management
wellness
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
14 Years
Minimum Age
10 Years
NCT Id
NCT03565744
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-5917
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth
Primary Outcomes
Outcome 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
Outcome Measure
Change in BMI
Outcome Time Frame
baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
Secondary Outcomes
Outcome 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
Outcome Time Frame
4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
Outcome Measure
Change in cardiovascular disease risk
Outcome 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
Outcome Time Frame
4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
Outcome Measure
Change in diabetes risk
Outcome 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
Outcome Time Frame
baseline, 12 - 13 months (final visit)
Outcome Measure
Change in nutrition and physical activity knowledge
Outcome Description
B'N Fit Survey includes questions assessing school attendance and performance.Visit schedule: Time 1) Baseline June screen; Time 5) Final June screen
Outcome Time Frame
baseline, 12 - 13 months (final visit)
Outcome Measure
Change in school attendance and performance
Outcome 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
Outcome Time Frame
Time Frame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
Outcome Measure
Change in target behaviors
Outcome 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
Outcome Time Frame
baseline, 12 - 13 months (final visit)
Outcome Measure
Change in fitness
Outcome 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
Outcome Time Frame
Clinic attendance: 4 -7 months, 8 - 10 months, 11 - 12 months; Afterschool attendance: 4-13 months
Outcome Measure
Program attendance
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
14
Minimum Age Number (converted to Years and rounded down)
10
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jessica Rieder
Investigator Email
jrieder@montefiore.org
Investigator Phone
718-920-2897 / 914-262-3792