Clinical trial NCT03565744: The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth
Official title: The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: obesity
adolescents
school-based
weight management
wellness
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2018-06-21
Enrollment: 79
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in BMI
timeFrame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
Secondary outcomes:
measure: Change in cardiovascular disease risk
timeFrame: 4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
measure: Change in diabetes risk
timeFrame: 4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
measure: Change in nutrition and physical activity knowledge
timeFrame: baseline, 12 - 13 months (final visit)
measure: Change in school attendance and performance
timeFrame: baseline, 12 - 13 months (final visit)
measure: Change in target behaviors
timeFrame: Time Frame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
measure: Change in fitness
timeFrame: baseline, 12 - 13 months (final visit)
measure: Program attendance
timeFrame: Clinic attendance: 4 -7 months, 8 - 10 months, 11 - 12 months; Afterschool attendance: 4-13 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: PS-95
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Elizabeth Walker, PhD, RN
role: STUDY_DIRECTOR
affiliation: Montefiore Medical Center
name: Jessica Rieder, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamron E, Moon JY, Meissner P, Wylie-Rosett J, Shankar V, Rieder J. Trends in health behavior at an afterschool program: the impact of COVID-19 on students' behavior. Res Sq [Preprint]. 2023 Mar 28:rs.3.rs-2679660. doi: 10.21203/rs.3.rs-2679660/v1.
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.
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.