Addressing Healthcare Disparities in Pediatric Obesity Treatment: Development of a Novel, Patient-centered Intervention Targeting Executive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Leptin
研究概览
简要总结
The purpose of this study is to develop and pilot test a new type of patient-centered, family-based treatment for children aged 8-12 with obesity and their caregivers. The treatment will focus specifically on improving children's self-regulation (SR) skills to help them better manage their feelings, behaviors, and thoughts to help them live a healthier lifestyle.
详细描述
We aim to: (1) To determine the treatment needs of children ages 8-12 with obesity and their families with a focus on understanding cognitive function challenges that are related to self-regulation (using focus groups i.e. FG and feedback sessions i.e. FB). (2) To evaluate the feasibility and acceptability of this novel family-based treatment. (3) Explore potential associations between pediatric cardiovascular (CVD) risk factors and self-regulation in children with and without overweight or obesity. (4) To refine the F-ABT protocol and to maximize participant feasibility, acceptability, safety, and tolerability of F-ABT. (5) To provide pilot, proof-of-concept, and preliminary efficacy data of beneficial effects of F-ABT on SR and BMI in children with SR deficits and their caregivers.
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
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who: (1) have a BMI ≥ 85th percentile; (2) are ≥8 and ≤12 years old at the beginning of treatment; (3) can read, write, and speak English, along with their caregiver; (4) plan to stay living in the local area during the study period; (5) have a consenting caregiver who can commit to all study procedures and provide reliable travel.
排除标准
- •Children who:(1) comorbid developmental/intellectual disability/traumatic brain injury/other identified condition known to substantially impact EF and/or weight management; (2) taking medication that is known to affect weight or appetite, (3) recent infection that may cause confounds of acute inflammation, (4) have an uncorrected visual or hearing impairment that would prohibit completion of cognitive testing, and (5) are unable to use an iPad with appropriate training for cognitive testing. The children without obesity (n=32) will have "normal-range" BMI scores (5th ≤BMI percentile< 85th) but otherwise follow the same inclusion/exclusion criteria.
结局指标
主要结局
Leptin
时间窗: Baseline to 4.5 months
ng/mL
Fasting glucose
时间窗: Baseline to 4.5 months
mg/dl
Blood pressure
时间窗: Baseline to 4.5 months
Systolic over diastolic
Insulin
时间窗: Baseline to 4.5 months
uU/ml
High-density lipoprotein (HDL-C) cholesterol
时间窗: Baseline to 4.5 months
mg/dl
Change in child body mass index
时间窗: Baseline to 4.5 months
Child height and weight measurements will be converted to zBMI using CDC age and sex specific scales.
Change in Health-Related Quality of Life
时间窗: Baseline to 4.5 months
Sizing Me Up© \& Sizing Them Up© are validated obesity-specific self-report and parent-report measures, respectively, of health-related quality of life for children 5-13 years old that measure functioning in a variety of areas (e.g., emotional, physical, teasing/marginalization). The Total Score will be used as the outcome, which is a scaled score ranging from 0-100 with higher scores representing better quality of life.
Cortisol
时间窗: Baseline to 4.5 months
ug/dl
Low-density lipoprotein (LDL-C) cholesterol
时间窗: Baseline to 4.5 months
mg/dl
Change in child objective executive function
时间窗: Baseline to 4.5 months
Performance-based EF will be tested using the NIH Toolbox Cognitive Battery which measures executive function (inhibitory control and cognitive flexibility), attention, episodic memory, language, processing speed, and working memory. T-scores will be used for each domain. Higher t-scores indicate better function.
Change in child subjective executive function
时间窗: Baseline to 4.5 months
Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function.
Triglyceride
时间窗: Baseline to 4.5 months
mg/dl
Hemoglobin A1C
时间窗: Baseline to 4.5 months
Percentage
Tumor necrosis factor (TNF-a)
时间窗: Baseline to 4.5 months
pg/ml
Interleukin (IL-6)
时间窗: Baseline to 4.5 months
pg/ml
High-sensitivity reactive protein (hsCRP)
时间窗: Baseline to 4.5 months
mg/L
次要结局
- Waist circumference(Baseline to 4.5 months)
- Mindfulness(Baseline to 4.5 months)
- Psychological flexibility(Baseline to 4.5 months)
- Child eating behavior(Baseline to 4.5 months)
- Child body fat percent(Baseline to 4.5 months)
- Dietary behavior(Baseline to 4.5 months)
- Physical activity behavior(Baseline to 4.5 months)
- Impact of the food environment(Baseline to 4.5 months)
研究者
Marissa Gowey
Assistant Professor
University of Alabama at Birmingham