NCT03190135

Brief Summary

BOKS, Build Our Kids' Success, is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Students participate in the program for 12 weeks, two or three mornings per week for about 1 hour per session. This study if a non-randomized control trial seeking to 1) examine the extent to which participation in the before-school BOKS program improves, health, well-being, and performance, and 2) compare the results of a two-day-per-week versus a three-day-per-week program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

9 months

First QC Date

June 9, 2017

Last Update Submit

June 15, 2017

Conditions

Overweight and ObesityAffectPhysical ActivityFitness

Keywords

OverweightObesitySchoolPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Body Mass Index at 12 weeks

    Body Mass Index (kg/m\^2): calculated from height and weight

    baseline, 12 weeks

  • Change from baseline Body Mass Index Z-score at 12 weeks

    Age- and sex- specific Body Mass Index Z-score

    baseline, 12 weeks

Secondary Outcomes (7)

  • Change from baseline 400 meter run time at 12 weeks

    baseline, 12 weeks

  • Change from baseline physical activity at 12 weeks

    baseline, 12 weeks

  • Change from baseline peer relationships at 12 weeks

    baseline, 12 weeks

  • Change from baseline positive affect at 12 weeks

    baseline, 12 weeks

  • Change from baseline life satisfaction at 12 weeks

    baseline, 12 weeks

  • +2 more secondary outcomes

Study Arms (3)

BOKS: 2 day per week

EXPERIMENTAL
Behavioral: BOKS: 2 day a week before-school physical activity program

BOKS: 3 day per week

EXPERIMENTAL
Behavioral: BOKS: 3 day a week before-school physical activity program

Non-BOKS

NO INTERVENTION

Interventions

BOKS: 2 day a week before-school physical activity programBEHAVIORAL

Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.

BOKS: 2 day per week
BOKS: 3 day a week before-school physical activity programBEHAVIORAL

Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.

BOKS: 3 day per week

Eligibility Criteria

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

You may qualify if:

  • Participating school
  • Child age 5-14 years

You may not qualify if:

  • No valid parental consent
  • Missing group assignment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Plymouth Public Schools

Plymouth, Massachusetts, 02360, United States

Location

Quincy Public Schools

Quincy, Massachusetts, 02169, United States

Location

Weymouth Public Schools

Weymouth, Massachusetts, 02190, United States

Location

Related Publications (2)

  • Pojednic R, Peabody S, Carson S, Kennedy M, Bevans K, Phillips EM. The effect of before school physical activity on child development: A study protocol to evaluate the Build Our Kids Success (BOKS) Program. Contemp Clin Trials. 2016 Jul;49:103-8. doi: 10.1016/j.cct.2016.06.009. Epub 2016 Jun 23.

    PMID: 27339866BACKGROUND

  • Whooten RC, Perkins ME, Gerber MW, Taveras EM. Effects of Before-School Physical Activity on Obesity Prevention and Wellness. Am J Prev Med. 2018 Apr;54(4):510-518. doi: 10.1016/j.amepre.2018.01.017. Epub 2018 Feb 12.

    PMID: 29449135DERIVED

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Elsie Taveras, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 16, 2017

Study Start

September 1, 2015

Primary Completion

May 31, 2016

Study Completion

May 31, 2016

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)