Fostering Patient-oriented Research in Cardiometabolic Disease Pathogenesis and Prevention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- T2 relaxation time by brain MRI
研究概览
简要总结
The goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study1: Adult caregiver and Child age 9-11y. Willing to come to in-person focus group
- •Study 2: Age 9-11y, BMI ≥85th and ≤95th percentile for age and sex
- •Study 3:Adult caregiver with child who qualify for free or reduced-cost lunch in WA State. Child age 9-11y and with overweight.
排除标准
- •(study 1 child participants and study 3 criteria for children of adult participants):
- •Significant health conditions including type 2 diabetes
- •History of major weight loss or eating disorder
- •Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
- •Documented cognitive disorder
- •Severe food allergies, vegetarian, or vegan (Study 1 only)
- •Unable to make the session date
- •Exclusion Criteria (study 2, child participants):
- •Significant health conditions including type 2 diabetes
- •History of major weight loss or eating disorder
- •Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
- •Documented cognitive disorder
- •MRI contraindication (e.g., braces, claustrophobia)
- •Weight >330 pounds (MRI limit)
- •Severe food allergies, vegetarian, or vegan
- •Currently in formal weight loss program
研究组 & 干预措施
Focus Group and Child Taste Test (Study 1)
No intervention is administered. Adult caregivers will participate in a focus group to assess feasibility of a controlled feeding study in children and children will complete a taste-test of a controlled feeding study menu.
Study-provided food (Study 2)
Participants will be provided all meals for a 7-day period. For the other 7-days of their enrollment, they will be asked to consume their usual diet.
干预措施: Diet modification (Other)
Focus Group (Study 3)
No intervention is administered. Adult caregivers of children will participate in a focus group to learn from families about participating in research involving feeding studies in children.
结局指标
主要结局
T2 relaxation time by brain MRI
时间窗: 7 days of diet intervention
次要结局
未报告次要终点
研究者
Ellen Schur, MD, MS
Professor: School of Medicine
University of Washington