Clinical trial NCT05464056: BUILT Family Lifestyle Program for Children with ADHD
Official title: BUILT Family Lifestyle Program for Children with ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Lifestyle Intervention
Routines
Behavior change
Community-engaged research
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: UIC Center for Health Equity Research (CHER)
name: UIC Chicago Partnership for Health Promotion (CPHP)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-07-19
Enrollment: 316
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Families enrolled in Chicago Park District programs will be offered the opportunity to participate in the BUILT family lifestyle program. Using a single group design, measures will be taken within two weeks of program start and two weeks after completion. Additional feasibility measures will be taken during the program itself to inform refinements across iterations. The BUILT program will occur largely on-line and consist of weekly home challenges related to food, sleep, and exercise that add up to form a comprehensive home routine--the routine will optimize neurocognitive development and home structure. The program will be co-facilitated by UIC students and Chicago Park District staff. For more information visit the program website: https://built.ahs.uic.edu.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline Moderate-Vigorous Physical Activity at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Sleep Quantity at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Diet Quality at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Recreational Screen Time Quantity at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Secondary outcomes:
measure: Change from Baseline Combined ADHD Symptoms at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Functional Impairment at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Executive Function at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Parental Stress at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Home Structure at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Family Cohesion at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Parent-Child Communication at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Physical Literacy at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Child Resilience at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
measure: Change from Baseline Social Capital at Posttest
timeFrame: Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Park District
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Eduardo E Bustamante, PhD
role: PRINCIPAL_INVESTIGATOR
References: