Clinical trial NCT06377384: FLIGHT Study for Childhood Chronic Illness
Official title: A Pilot and Feasibility Study Focusing on Lifestyle, Environmental Modifications, and Transdisciplinary Clinical Care for Children With Chronic Illness: Protocol for the FLIGHT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Illnesses, Multiple
Keywords: children
chronic illness
total allostatic load
FLIGHT
functional medicine
environmental medicine
lifestyle medicine
root-cause medicine
personalized medicine
Lead sponsor: Documenting Hope Project
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 14
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Total Load Index (TLI)
timeFrame: Baseline and 18 months
Secondary outcomes:
measure: Child Health Inventory for Resilience and Prevention (CHIRP)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
measure: Vineland Adaptive Behavior Scale
timeFrame: Baseline, 9 months, 18 months
measure: Sensory Profile 2
timeFrame: Baseline, 9 months, 18 months
measure: Quick Environmental Exposure and Sensitivity Inventory (QEESI)
timeFrame: Baseline, 9 months, 18 months
measure: Hayward Environmental Illness Severity Scale
timeFrame: Baseline, 9 months, 18 months
measure: Parenting Stress Index, 4th edition (PSI-4)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Other outcomes:
Locations:
city: Windsor
country: United States
facility: Epidemic Answers
state: Connecticut
Study officials:
References: