NCT03805295

Brief Summary

This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Two sessions will be held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

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

February 16, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

December 23, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

January 11, 2019

Results QC Date

May 22, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index (kg/m^2)

    calculated from height and weight

    Baseline, Follow-up for each session (12 weeks)

Secondary Outcomes (2)

  • Change in Executive Function

    Baseline, Follow-up for each session (12 weeks)

  • Change in Quality of Life PedsQL

    Baseline, Follow-up for each session (12 weeks)

Study Arms (2)

Spring 2018 Participation

EXPERIMENTAL

Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018.

Other: BOKS Program

Fall 2018 Participation

EXPERIMENTAL

Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018.

Other: BOKS Program

Interventions

12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.

Fall 2018 ParticipationSpring 2018 Participation

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in the BOKS program
  • Participating school
  • Age 5-14

You may not qualify if:

  • No valid consent
  • Not enrolled in BOKS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Rachel Whooten
Organization
Massachusetts General Hospital

Study Officials

  • Elsie Taveras, MD

    MGH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of General Pediatrics

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

February 16, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

December 23, 2025

Results First Posted

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations