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FLIGHT Study for Childhood Chronic Illness

Recruiting
2 - 15 years of age
Both
Phase 1

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Overview

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.

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 ΒΌ 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

Study details

Chronic Illnesses, Multiple

NCT06377384

Documenting Hope Project

30 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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