FLIGHT Study for Childhood Chronic Illness

NCT06377384 | Completed Phase 1

• 1 other identifier: DHP-33-FLIGHT
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Illnesses, Multiple

Keywords

children; chronic illness; total allostatic load; FLIGHT; functional medicine; environmental medicine; lifestyle medicine; root-cause medicine; personalized medicine

Outcome Measures

Primary Outcomes (1)

• Total Load Index (TLI)

  The TLI is a measure of environmental, chemical, and social stressors that interact to contribute to chronic illness. There is no numeric score.

  Baseline and 18 months

Secondary Outcomes (8)

• 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

• Vineland Adaptive Behavior Scale

  Baseline, 9 months, 18 months

• Sensory Profile 2

  Baseline, 9 months, 18 months

• Quick Environmental Exposure and Sensitivity Inventory (QEESI)

  Baseline, 9 months, 18 months

Study Arms (1)

FLIGHT Intervention

EXPERIMENTAL

Other: FLIGHT Intervention

Interventions

FLIGHT Intervention OTHER

Personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care.

FLIGHT Intervention

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Documenting Hope Project: lead

Study Sites (1)

Epidemic Answers

Windsor, Connecticut, 06095, United States

Location

MeSH Terms

Conditions

Multiple Chronic Conditions; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: April 20, 2022
• Primary Completion: April 30, 2024
• Study Completion: June 7, 2024
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

US (1)