NCT06377384已完成1 期
A Pilot and Feasibility Study Focusing on Lifestyle, Environmental Modifications, and Transdisciplinary Clinical Care for Children With Chronic Illness: Protocol for the FLIGHT Study
Documenting Hope Project2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2022年4月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Total Load Index (TLI)
研究概览
简要总结
The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study.
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
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one guardian must have the ability to read and write English
- •Participant and participant's caregiver must reside in the United States and live within the designated recruitment areas
- •Verified completion of the CHIRP survey and consent to participate in the FLIGHT Study screening process
- •Candidate's diagnosis(es) falls into one or more of the following categories:
- •Immune/Autoimmune Conditions (for example: juvenile idiopathic arthritis, juvenile rheumatoid arthritis, asthma, eczema, atopic illness, allergies, Crohn's disease, ulcerative colitis, other gastrointestinal disorders, lupus, other autoimmune conditions)
- •Conditions of Metabolic Dysregulation (for example: obesity/type 2 diabetes)
- •Mood/Behavioral/Developmental Conditions (for example: autism spectrum disorders, ADHD/ADD, depression, obsessive-compulsive disorder, anxiety)
- •Candidate is able to provide sufficient documentation of diagnoses, including validated/standardized diagnostic criteria in current use by specialists for each respective diagnosis, which have been performed by a professional with requisite experience or training
排除标准
- •Candidate is a family member or close associate of any employees or board members of Epidemic Answers, members of the FLIGHT Study Team, or any advisors or clinicians associated with the FLIGHT Study
- •Candidate is not able to provide documentation for proof of diagnoses
- •Diagnosis with a condition that is severe enough to preclude participation in the intensive, multi-modal lifestyle intervention
- •Caregiver(s) with health (e.g., serious chronic disease, disability, addiction) or other life circumstances (e.g., lack of transportation, shared custody of child) that preclude full participation in the intensive intervention
- •External sources of environmental toxicants to the home or school environment that cannot be modified (e.g., high tension power line directly adjacent to home, coal-fired power plant within a ¼ mile of family's home)
- •Inability to control/modify child's diet at daycare or with childcare provider
- •Caregiver(s) anticipate a change of geographic location within two years
- •Parent or caregiver has explicit belief that child's condition cannot be improved
- •Caregiver(s) unwilling to make lifestyle changes, restrict candidate's non-essential technology use. prepare the majority of the family meals at home, replace personal and household products if indicated
- •Caregiver(s) unwilling to have the candidate assessed by a team of doctors and/or healthcare practitioners including, but not limited to: physician, chiropractor, acupuncturist, optometrist, nutritionist, or other professionals recommend by the program
- •Caregiver(s) unwilling to have the candidate participate in minimally invasive laboratory or non-laboratory assessments
- •Caregiver(s) unwilling to have the candidate participate in required periodic video interviews, and other audio-visual documentation
- •Candidate is pregnant
- •Candidate has been convicted of a felony, is currently on probation, or in a juvenile detention center
结局指标
主要结局
Total Load Index (TLI)
时间窗: Baseline and 18 months
The TLI is a measure of environmental, chemical, and social stressors that interact to contribute to chronic illness. There is no numeric score.
次要结局
- Beck Anxiety Inventory (BAI)(Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months)
- Child Health Inventory for Resilience and Prevention (CHIRP)(Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months)
- Children's Sleep Habits Questionnaire (CSHQ)(Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months)
- Quick Environmental Exposure and Sensitivity Inventory (QEESI)(Baseline, 9 months, 18 months)
- Vineland Adaptive Behavior Scale(Baseline, 9 months, 18 months)
- Sensory Profile 2(Baseline, 9 months, 18 months)
- Hayward Environmental Illness Severity Scale(Baseline, 9 months, 18 months)
- Parenting Stress Index, 4th edition (PSI-4)(Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months)
研究者
研究点 (2)
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