NCT05464056

Brief Summary

The investigators have developed BUILT in hopes of empowering families to adopt and sustain healthy food, sleep, and exercise routines that optimize child focus, attention, and behavior. Over 6-weeks, the BUILT program will explore what science says about the effects of sleep, nutrition, and exercise on brain development and behavior; investigate the food, sleep, and exercise routines of the world's best athletes and intellectuals; and experiment with home routines to find those that best fits with participating families. It is hypothesized that families participating in BUILT (N=150) will show significant improvements in child health behaviors (sleep, nutrition, physical activity, recreational screen time), child mental health (ADHD symptoms \[primary outcome\], child functional impairment), child physical literacy, and family dynamics (cohesion, structure, communication) from baseline to posttest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

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

First Submitted

Initial submission to the registry

May 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 19, 2026

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

May 26, 2022

Last Update Submit

May 15, 2026

Conditions

Keywords

ADHDLifestyle InterventionRoutinesBehavior changeCommunity-engaged research

Outcome Measures

Primary Outcomes (4)

  • Change from Baseline Moderate-Vigorous Physical Activity at Posttest

    Physical activity will be monitored for children at each time point with accelerometers worn at the wrist. Accelerometers provide a valid assessment of physical activity in free-living conditions. Data will be analyzed if ≥7 hours are available for ≥4 days. The outcome is minutes of moderate-vigorous physical activity per day and more minutes of moderate-vigorous physical activity are considered a better outcome.

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

  • Change from Baseline Sleep Quantity at Posttest

    Sleep quantity will be monitored for children at each time point with accelerometers worn at the wrist. Accelerometers provide a valid assessment of sleep in free-living conditions. Sleep logs will differentiate sleep and wake times. More hours of sleep are considered a better outcome.

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

  • Change from Baseline Diet Quality at Posttest

    Diet Quality will be assessed for each child at each time point using a Block Food Frequency Questionnaire (NutritionQuest). Higher scores on Diet Quality are considered a better outcome.

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

  • Change from Baseline Recreational Screen Time Quantity at Posttest

    Recreational Screen time will be assessed by parent report of minutes of daily screen time on weekdays and weekends for school and non-school purposes, rounded to the nearest 15-minute increment. Fewer minutes of daily recreational screen time are considered a better outcome.

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

Secondary Outcomes (10)

  • Change from Baseline Combined ADHD Symptoms at Posttest

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

  • Change from Baseline Functional Impairment at Posttest

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

  • Change from Baseline Executive Function at Posttest

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

  • Change from Baseline Parental Stress at Posttest

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

  • Change from Baseline Home Structure at Posttest

    Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)

  • +5 more secondary outcomes

Study Arms (1)

BUILT Study

EXPERIMENTAL

One group receives the intervention.

Behavioral: Be Unstoppable in Life Together (BUILT)

Interventions

Participants will complete weekly sleep, food, and exercise home challenges focused on creating sustainable healthy eating, sleep, and exercise routines. Parents will participate in weekly support calls by UIC and Chicago Park District staff to provide support and accountability. Children will have the opportunity to win small prizes based on completing weekly challenges. The intervention will be co-facilitated by UIC students and Chicago Park District staff and will largely take place on-line. For additional details visit: https://built.ahs.uic.edu.

BUILT Study

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Boys and girls ages 6 to 12 years old
  • Parent orientation session summarizing activities
  • Child free of conditions that preclude aerobic activity
  • Child enrolled in Chicago Park District programming

You may not qualify if:

  • Boys and girls \< 6 years old or \> 12 years old
  • Parent does not participate in orientation session summarizing activities
  • Child has conditions that preclude aerobic activity
  • Child not enrolled in Chicago Park District programming

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chicago Park District

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Eduardo E Bustamante, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AssociateProfessor

Study Record Dates

First Submitted

May 26, 2022

First Posted

July 19, 2022

Study Start

July 15, 2022

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

May 19, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations