ClinicalTrials.gg
CompletedNCT06377384Updated Oct 6, 2025

FLIGHT Study for Childhood Chronic Illness

A Phase 1 interventional study of FLIGHT Intervention in Chronic Illnesses, Multiple, sponsored by Documenting Hope Project. Completed at 1 site in United States. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-10-06.

Sponsored by Documenting Hope Project · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2022, registered Apr 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
2 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Illnesses, Multiple

Keywords

  • children
  • chronic illness
  • total allostatic load
  • FLIGHT
  • functional medicine
  • environmental medicine
  • lifestyle medicine
  • root-cause medicine
  • personalized medicine
03

In context

Multiple Chronic Conditions

89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.

This study's enrollment of 2 is below the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.

Browse Multiple Chronic Conditions studies →

Lead sponsor

Documenting Hope Project is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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/ 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    FLIGHT Intervention

    Other: FLIGHT Intervention

Interventions

  • OtherFLIGHT Intervention

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

06

What researchers measure

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.

    Time frame: Baseline and 18 months

Secondary outcomes

  1. Child Health Inventory for Resilience and Prevention (CHIRP)

    Comprehensive survey evaluating total load of health stressors and supports influencing children. There is no numeric score.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

  2. Children's Sleep Habits Questionnaire (CSHQ)

    Survey that assesses sleep. It consists of 35 items scored on a 1-3 point scale, with higher scores indicating worse sleep.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

  3. Vineland Adaptive Behavior Scale

    Survey assessing developmental and other disorders. A standard score of 100 is considered average, with scores above 100 indicating strengths in adaptive behavior and scores below 100 indicating areas of difficulty.

    Time frame: Baseline, 9 months, 18 months

  4. Sensory Profile 2

    Survey assessing child's sensory processing patterns. There are 86 items. For each item, a score of 0 indicates that the individual's sensory processing is consistent with age-based norms. Positive scores suggest that the individual's sensory processing is better than age-based norms, while negative scores indicate that the individual's sensory processing is weaker than age-based norms.

    Time frame: Baseline, 9 months, 18 months

  5. Quick Environmental Exposure and Sensitivity Inventory (QEESI)

    Survey that assesses environmental toxicants. The QEESI contains 50 items scored on a 0 to 10 scale with higher scores indicating greater environmental sensitivities.

    Time frame: Baseline, 9 months, 18 months

  6. Hayward Environmental Illness Severity Scale

    Survey assessing impact of home environment on health. The survey consists of 22 questions with total score ranges from 0 to 100. Higher scores indicating greater severity of environmenal sensitivity symptoms.

    Time frame: Baseline, 9 months, 18 months

  7. Parenting Stress Index, 4th edition (PSI-4)

    Survey assessing stress among parents. The PSI-4 contains 120 items with higher scores indicating greater levels of stress.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

  8. Beck Anxiety Inventory (BAI)

    Survey assessing anxiety. The survey contains 21 items with scores ranging from 0 to 63. Higher scores indicate greater levels of anxiety.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months

07

Study locations

1 site
  • Epidemic Answers
    Windsor, Connecticut 06095, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Apr 2024, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2024
First posted
Apr 22, 2024
StartActual
Apr 20, 2022
Primary completionActual
Apr 30, 2024
CompletionActual
Jun 7, 2024
Last update
Oct 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06377384
Lead sponsor
Documenting Hope Project
Responsible party
Sponsor
First posted
Apr 22, 2024
Start date
Apr 20, 2022
Primary completion
Apr 30, 2024
Completion
Jun 7, 2024
Last update
Oct 6, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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