Personalized intervention for children with chronic illnesses
A Pilot and Feasibility Study Focusing on Lifestyle, Environmental Modifications, and Transdisciplinary Clinical Care for Children With Chronic Illness: Protocol for the FLIGHT Study
PHASE1 · Documenting Hope Project · NCT06377384
This study is testing a tailored program to help children with chronic illnesses by focusing on lifestyle changes and environmental improvements to see if it makes a difference in their health.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 2 Years to 15 Years |
| Sex | All |
| Sponsor | Documenting Hope Project (other) |
| Locations | 1 site (Windsor, Connecticut) |
| Trial ID | NCT06377384 on ClinicalTrials.gov |
What this trial studies
The FLIGHT study is an open-label, single-arm pilot study that aims to evaluate a personalized and multimodal intervention targeting modifiable lifestyle factors and environmental modifications for children suffering from chronic illnesses. This study will involve up to 14 participants and will assess the feasibility and effectiveness of these strategies through a mixed methods outcomes evaluation. The primary goal is to identify promising approaches that can be streamlined and scaled for broader application in future interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with chronic illnesses such as autoimmune conditions, metabolic dysregulation, or mood/behavioral/developmental disorders.
Not a fit: Patients who do not have a chronic illness or whose conditions do not fall into the specified categories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide tailored interventions that significantly improve the health and quality of life for children with chronic illnesses.
How similar studies have performed: While this approach is innovative, similar studies focusing on personalized interventions for chronic illnesses in children have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Windsor, Connecticut
- Epidemic Answers — Windsor, Connecticut, United States (RECRUITING)
Study contacts
- Study coordinator: Study Coordinator
- Email: info@epidemicanswers.org
- Phone: 833-935-5543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Illnesses, Multiple, children, chronic illness, total allostatic load, FLIGHT, functional medicine, environmental medicine, lifestyle medicine