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临床试验/NCT05464056
NCT05464056已完成不适用

BUILT Family Lifestyle Program for Children With ADHD

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2022年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Change from Baseline Moderate-Vigorous Physical Activity at Posttest

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

BUILT Study

Experimental

One group receives the intervention.

干预措施: Be Unstoppable in Life Together (BUILT) (Behavioral)

结局指标

主要结局

Change from Baseline Moderate-Vigorous Physical Activity at Posttest

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

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.

Change from Baseline Sleep Quantity at Posttest

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

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.

Change from Baseline Diet Quality at Posttest

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

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.

Change from Baseline Recreational Screen Time Quantity at Posttest

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

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.

次要结局

  • Change from Baseline Home Structure at Posttest(Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date))
  • 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 Parental Stress at Posttest(Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date))
  • Change from Baseline Family Cohesion at Posttest(Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date))
  • Change from Baseline Physical Literacy at Posttest(Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date))
  • Change from Baseline Social Capital 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 Parent-Child Communication at Posttest(Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date))
  • Change from Baseline Child Resilience at Posttest(Baseline (within 2-weeks of intervention start date), Posttest (within 2-weeks of intervention end date))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eduardo E. Bustamante

AssociateProfessor

University of Illinois at Chicago

研究点 (2)

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