RECRUITING

FLIGHT Study for Childhood Chronic Illness

Conditions

Chronic Illnesses, Multiple children chronic illness total allostatic load FLIGHT functional medicine environmental medicine lifestyle medicine root-cause medicine personalized medicine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-04-20

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06377384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 15 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

833-935-5543

info@epidemicanswers.org

Study Locations (Sites)

Epidemic Answers

Windsor, Connecticut, 06095

United States

Collaborators and Investigators

Sponsor: Documenting Hope Project

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-20

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-04-20

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Chronic Illnesses, Multiple