FLIGHT Study for Childhood Chronic Illness

Documenting Hope Project

Status and phase

Completed

Phase 1

Conditions

Chronic Illnesses, Multiple

Treatments

Other: FLIGHT Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06377384

DHP-33-FLIGHT

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

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