NCT03565744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

May 2, 2018

Last Update Submit

March 14, 2024

Conditions

Overweight and Obesity

Keywords

obesityadolescentsschool-basedweight managementwellness

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)

Secondary Outcomes (7)

  • Change in cardiovascular disease risk

    4 -7 months (baseline clinic visit), 11 - 12 months (final clinic visit) if abnormal during the baseline clinic visit

  • Change in diabetes risk

    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

    baseline, 12 - 13 months (final visit)

  • Change in school attendance and performance

    baseline, 12 - 13 months (final visit)

  • Change in target behaviors

    Time Frame: baseline, 4 -7 months, 8 - 10 months, 11 - 12 months, 12 - 13 months (final visit)

  • +2 more secondary outcomes

Study Arms (3)

Group 1 - B'N Fit POWER

EXPERIMENTAL

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

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.

Interventions

B'N Fit POWERBEHAVIORAL

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.

Group 1 - B'N Fit POWER

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PS-95

The Bronx, New York, 10467, United States

Location

Related Publications (3)

  • 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.

    PMID: 37034787BACKGROUND

  • 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.

    PMID: 29850232RESULT

  • 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.

    PMID: 33827501RESULT

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Walker, PhD, RN

    Albert Einstein College of Medicine

    STUDY DIRECTOR

  • Jessica Rieder, MD, MS

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

June 21, 2018

Study Start

June 15, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Locations

US(1)