Overweight and ObesityBNFitNCT03565744
The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth
A study testing B'N Fit POWER in people with Overweight and Obesity, run by Montefiore Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- B'N Fit POWER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- B'N Fit POWER
- Keywords
- obesity, adolescents, school-based, weight management, wellness
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B'N Fit POWERBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - B'N Fit POWER | Experimental | Participants enrolling in B'N Fit POWER afterschool program will be assigned to Group 1. Receives: Behavioral: B'N Fit POWER |
| Group 2 - Standard of Care | No intervention | All other PS/MS-95 participants who completed the screening (approximately 50) will be in comparison Group 2 |
| Group 3 - Standard of Care | No intervention | Participants at an additional school site completing the screening (approximately 100) will be in an additional comparison Group 3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
Secondary outcomes (7)
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
Measured: 4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
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
Measured: 4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
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
Measured: baseline, 12 - 13 months (final visit)
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
Measured: baseline, 12 - 13 months (final visit)
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
Measured: Time Frame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
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
Measured: baseline, 12 - 13 months (final visit)
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
Measured: Clinic attendance: 4 -7 months, 8 - 10 months, 11 - 12 months; Afterschool attendance: 4-13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start15 Jun 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Walker, PhD, RN, Study director, Albert Einstein College of MedicineJessica Rieder, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565744
- Sponsor's protocol ID
- 2015-5917
- Acronym
- BNFit
- Status last verified
- Mar 2024
- First submitted
- 2 May 2018
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37034787Rieder 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.
PubMed 29850232Rieder 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.
PubMed 33827501
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth
- ClinicalTrials.gov ID
- NCT03565744
- Acronym / sponsor ID
- BNFit / 2015-5917
- Conditions
- Overweight and Obesity
- Keywords
- obesity, adolescents, school-based, weight management, wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - B'N Fit POWER | Experimental | Behavioral: B'N Fit POWERParticipants enrolling in B'N Fit POWER afterschool program will be assigned to Group 1. |
| Group 2 - Standard of Care | No intervention | –All other PS/MS-95 participants who completed the screening (approximately 50) will be in comparison Group 2 |
| Group 3 - Standard of Care | No intervention | –Participants at an additional school site completing the screening (approximately 100) will be in an additional comparison Group 3. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B'N Fit POWERParticipants 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. | Behavioural | Group 1 - B'N Fit POWER |
Primary outcome
Change in BMI
Time frame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
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
7 secondary outcomes
Change in cardiovascular disease risk
Time frame: 4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
Change in diabetes risk
Time frame: 4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit
Change in nutrition and physical activity knowledge
Time frame: baseline, 12 - 13 months (final visit)
Change in school attendance and performance
Time frame: baseline, 12 - 13 months (final visit)
Change in target behaviors
Time frame: Time Frame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)
Change in fitness
Time frame: baseline, 12 - 13 months (final visit)
Program attendance
Time frame: Clinic attendance: 4 -7 months, 8 - 10 months, 11 - 12 months; Afterschool attendance: 4-13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 37034787Yamron 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.
- Results publication: PubMed 29850232Rieder 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 publication: PubMed 33827501Rieder 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Walker, PhD, RN study director
Albert Einstein College of Medicine
Jessica Rieder, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B'N Fit POWER in people with Overweight and Obesity, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (time frame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565744, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.