Chronic Illnesses, MultiplePhase 1NCT06377384
FLIGHT Study for Childhood Chronic Illness
A Phase 1 study testing FLIGHT Intervention in people with Chronic Illnesses, Multiple, run by Documenting Hope Project at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Chronic Illnesses, Multiple
- What is being tested?
- FLIGHT Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2022to 7 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- FLIGHT Intervention
- Keywords
- children, chronic illness, total allostatic load, FLIGHT, functional medicine, environmental medicine, lifestyle medicine, root-cause medicine, personalized medicine
- Medical subject headings
- Multiple Chronic Conditions, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIGHT InterventionOther
Personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care.
| Study group | Role | What they receive |
|---|---|---|
| FLIGHT Intervention | Experimental | Not described Receives: Other: FLIGHT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 18 months
Secondary outcomes (8)
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
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.
Measured: Baseline, 9 months, 18 months
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.
Measured: Baseline, 9 months, 18 months
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.
Measured: Baseline, 9 months, 18 months
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.
Measured: Baseline, 9 months, 18 months
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start20 Apr 2022
- Primary completion30 Apr 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Illnesses, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Documenting Hope Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377384
- Sponsor's protocol ID
- DHP-33-FLIGHT
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06377384
- Acronym / sponsor ID
- DHP-33-FLIGHT
- Conditions
- Chronic Illnesses, Multiple
- Keywords
- children, chronic illness, total allostatic load, FLIGHT, functional medicine, environmental medicine, lifestyle medicine, root-cause medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Documenting Hope ProjectUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLIGHT Intervention | Experimental | Other: FLIGHT Intervention |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLIGHT InterventionPersonalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care. | Other | FLIGHT Intervention |
Primary outcome
Total Load Index (TLI)
Time frame: 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.
8 secondary outcomes
Child Health Inventory for Resilience and Prevention (CHIRP)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Vineland Adaptive Behavior Scale
Time frame: Baseline, 9 months, 18 months
Sensory Profile 2
Time frame: Baseline, 9 months, 18 months
Quick Environmental Exposure and Sensitivity Inventory (QEESI)
Time frame: Baseline, 9 months, 18 months
Hayward Environmental Illness Severity Scale
Time frame: Baseline, 9 months, 18 months
Parenting Stress Index, 4th edition (PSI-4)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Beck Anxiety Inventory (BAI)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FLIGHT Intervention in people with Chronic Illnesses, Multiple, run by Documenting Hope Project at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Load Index (TLI) (time frame: Baseline and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.