FLIGHT Intervention for Chronic Illness

Overseen By Study Coordinator

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Documenting Hope Project

Disqualifiers: Severe condition, Caregiver health, Environmental toxicants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best methods to help children with chronic illnesses improve their health through lifestyle changes and a team-based care approach. It examines how factors like diet, environment, and various healthcare types can impact health. The FLIGHT Intervention, a personalized lifestyle program, suits children with conditions such as asthma, eczema, type 2 diabetes, autism, or anxiety, who can provide proof of diagnosis. Participants and their caregivers must reside in specific U.S. areas and be willing to adopt lifestyle changes and explore new healthcare approaches. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a unique opportunity to be among the first to receive this innovative intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the study team to get a clear answer.

What prior data suggests that the FLIGHT Intervention is safe for children with chronic illness?

Research shows that lifestyle programs, such as the FLIGHT Intervention, are generally safe and easy to follow. Studies on similar programs have demonstrated health benefits, including improved sleep and healthier eating habits, without major side effects.

As a Phase 1 study, the primary focus is on safety. These studies are typically small and closely monitored to ensure participants' well-being. Although specific safety data for the FLIGHT Intervention is not yet available, its Phase 1 status suggests that earlier research has likely addressed any major safety concerns.

Overall, lifestyle programs are usually low-risk, particularly when customized to fit individual needs, as in the FLIGHT study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care options for chronic illness management, which often include medication and lifestyle changes, the FLIGHT Intervention is unique because it focuses on a holistic approach that integrates psychological and behavioral strategies. Researchers are excited about this intervention because it aims to empower patients by enhancing their self-management skills and improving their mental health, potentially leading to better overall health outcomes. This approach could offer a more personalized and sustainable way to manage chronic illnesses, addressing both the physical and emotional aspects of the condition.

What evidence suggests that the FLIGHT Intervention could be effective for chronic illness?

Research has shown that lifestyle changes can improve the health of children with long-term illnesses. Studies have found that focusing on good sleep, a healthy diet, and regular exercise leads to better health habits and a higher quality of life. In similar programs, participants experienced improvements in weight and blood pressure. Another study found that combining lifestyle changes with regular medical care improved overall well-being. These findings suggest that personalized lifestyle changes, such as those tested in the FLIGHT Intervention in this trial, may help manage chronic conditions in children. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

The FLIGHT study is for children with chronic illness, including those with multiple health conditions. It aims to improve their well-being through lifestyle changes and environmental adjustments, guided by a team of experts. Children must be able to participate in the intervention and assessments.

Inclusion Criteria

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

At least one guardian must have the ability to read and write English

Exclusion Criteria

Caregiver(s) with health or other life circumstances that preclude full participation in the intensive intervention

Inability to control/modify child's diet at daycare or with childcare provider

Candidate is pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized and multimodality intervention focusing on modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care

18 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FLIGHT Intervention

Trial Overview This pilot study tests the FLIGHT Intervention—a personalized program that combines lifestyle modifications and specialized clinical care—to see which strategies work best for kids with chronic diseases.

How Is the Trial Designed?

Group I: FLIGHT Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Documenting Hope Project

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

Inpatient medical rehabilitation significantly improved disease-related self-management in children with obesity (n=706) and bronchial asthma (n=162), with a strong effect size in the obesity group (SRM=0.84) and a moderate effect in the asthma group (SRM=0.42).

For children with bronchial asthma, effective self-management after rehabilitation was strongly predicted by their initial self-management skills, while the predictors for the obesity group were less clear, suggesting that different factors may influence treatment success in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Disease-related self-management of obese children and children with bronchial asthma: changes and predictors during inpatient rehabilitation]. Gustke, M., Petermann, F., Farin, E.[2011]

A personalized, web-based asthma education program was developed for parents of children aged 4 to 12 with moderate to severe asthma, incorporating tailored messages and support from a human coach to enhance asthma self-management skills.

The program includes features like an Asthma Manager and monthly phone calls from an asthma-nurse case manager, and is currently being evaluated in a randomized study to assess its effectiveness in improving medication adherence, asthma control, and parent quality of life over a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet telehealth for pediatric asthma case management: integrating computerized and case manager features for tailoring a Web-based asthma education program. Wise, M., Gustafson, DH., Sorkness, CA., et al.[2023]

Both face-to-face and Internet videoconferencing methods of delivering Behavioral Family Systems Therapy for Diabetes (BFST-D) showed no significant differences in effectiveness for improving adherence and glycemic control among adolescents with type 1 diabetes, based on a study involving participants aged 12 to 18 over 12 weeks.

Overall, BFST-D led to significant improvements in adherence and glycemic control from before to after the intervention, with these benefits maintained at a 3-month follow-up, indicating that Internet-based therapy is a viable option for families facing barriers to traditional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Harris, MA., Freeman, KA., Duke, DC.[2018]

A systematic review of 18 studies found that while some psychosocial interventions, particularly asthma education and art therapy, can lead to significant improvements in health-related quality of life (HRQOL) for asthmatic children, the overall evidence for effectiveness is limited.

Most interventions focused on asthma education without addressing family dynamics, suggesting that future programs should combine education with strategies to enhance family involvement in asthma management to better improve HRQOL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of psychosocial interventions designed to improve health-related quality of life (HRQOL) amongst asthmatic children and their families: a systematic review. Clarke, SA., Calam, R.[2021]

Parents of children with chronic illnesses often focus more on managing the illness rather than promoting overall health, which can lead to imbalances in health promotion efforts.

Families face additional health risks that require significant lifestyle adjustments, including changes in nutrition, exercise, and coping strategies, highlighting the need for comprehensive support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health promotion during childhood chronic illness: a paradox facing society. Heinzer, MM.[2019]

The Aironet educational program significantly reduced the number of asthma attacks in children with intermittent or mild persistent asthma, with an average of 1.65 attacks in the education group compared to 2.34 in the control group over 12 months.

Parents of children who experienced three or more asthma attacks at baseline showed a greater improvement in their knowledge of asthma after participating in the Aironet program, highlighting its effectiveness in both managing the disease and educating families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of a Long-term Educational Program for children with asthma - Aironet. A 1-yr randomized controlled trial. Indinnimeo, L., Bonci, E., Capra, L., et al.[2009]

The pilot program by the American Lung Association successfully educated 84 urban black asthmatic children, leading to a significant reduction in school absences, emergency room visits, and hospitalizations by 36% to 69%.

Follow-up interviews indicated that the majority of participants adopted new asthma management techniques, such as using inhalers (78%) and practicing breathing exercises (55%), demonstrating the program's effectiveness in teaching daily management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel asthma camp intervention for childhood asthma among urban blacks. The Pediatric Lung Committee of the American Lung Association of the District of Columbia (ALADC) Washington, DC. Fitzpatrick, SB., Coughlin, SS., Chamberlin, J.[2022]

A novel nurse telephone coaching intervention was tested in a randomized, controlled trial to improve asthma self-management for parents of children aged 5 to 12 with persistent asthma.

Despite existing guidelines, maintenance asthma care remains inadequate, highlighting the need for effective support systems like this coaching intervention to enhance care and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone coaching intervention to improve asthma self-management behaviors. Swerczek, LM., Banister, C., Bloomberg, GR., et al.[2022]

Family interventions for managing chronic health problems show promise, particularly in improving communication and problem-solving skills among families dealing with illnesses like cancer and diabetes.

Most studies reviewed focused on time-limited therapeutic interventions rather than family psychotherapy models, indicating a need for more research on effective family-based approaches to support patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple and family interventions in health problems. Shields, CG., Finley, MA., Chawla, N., et al.[2022]

Citations

1. trialx.com trialx.com/clinical-trials/listings/288788/flight-study-for-childhood-chronic-illness/

FLIGHT Study for Childhood Chronic Illness The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon ...

2. withpower.com withpower.com/trial/phase-1-chronic-disease-3-2022-fd8dc

FLIGHT Intervention for Chronic Illness · Info for Participants The FLIGHT study is for children with chronic illness, including those with multiple health conditions. It aims to improve their well-being through lifestyle ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7957121/

The effectiveness of a 17-week lifestyle intervention on ... A 3-component healthy sleep, eating, and PA intervention elicit improvements in health behaviors and perceived subjective health in pilots.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06640179

NCT06640179 | Feasibility and Plausible Effectiveness of a ... Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on health-related quality of life ...

5. mdpi.com mdpi.com/2072-6643/13/12/4288

The Effects of a Brief Lifestyle Intervention on the Health ... A brief three-component healthy sleep, diet and physical activity intervention can elicit and sustain long-term improvements in body mass and blood pressure ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10855981/

Personalized Multimodal Lifestyle Intervention as the Best ... Furthermore, chronic pain is correlated with a reduced life expectancy [13,14], attributed in part to increased mortality from cancer and cardiovascular disease ...