FLIGHT Study for Childhood Chronic Illness

Chronic Illnesses, Multiple Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06377384
• Other study ID #: DHP-33-FLIGHT
• Status: Recruiting
• Phase: Phase 1
• Start date: April 20, 2022
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Documenting Hope Project
• Contact: Study Coordinator
• Phone: 833-935-5543
• Email: info[@]epidemicanswers.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illnesses, Multiple
• Multiple Chronic Conditions

Intervention

Other:
• FLIGHT Intervention
Personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care.

Locations

Country	Name	City	State
United States	Epidemic Answers	Windsor	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Documenting Hope Project

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Secondary	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.	Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Secondary	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.	Baseline, 9 months, 18 months
Secondary	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.	Baseline, 9 months, 18 months
Secondary	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.	Baseline, 9 months, 18 months
Secondary	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.	Baseline, 9 months, 18 months
Secondary	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.	Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Secondary	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.	Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months