Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 2:05 PM
Study NCT ID:
NCT06616857
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Sponsor:
Nemours Children's Clinic
Organization:
Study Overview
Official Title:
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUDGE
Brief Summary:
The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis (CF), medically stable, able to speak and read English, and are not experiencing a CF - related exacerbation, who are already active to remain, or gradually encourage them to increase their levels of physical activity
Participants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal:
* Set and review goals
* Self-monitor progress
* Provide feedback on goal attainment
* Revise future goals
Participants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal:
* Set and review goals
* Self-monitor progress
* Provide feedback on goal attainment
* Revise future goals
Detailed Description:
The goal of this study is to conduct a 6-month delayed treatment pilot Trial with adolescents and young adults (AYA) ages 13-25 with Cystic Fibrosis (CF) or a CF related disorder) to establish feasibility and obtain data necessary to inform a Phase III efficacy trial. AYAs 18 years-old and caregivers of AYAs 13-17 years-old will complete the informed consent process. AYAs 13-17 years-old will be asked to assent to participate in the study. After completion of the baseline study measures and return of actigraphy monitors, staff will notify AYAs of their randomized assignment. AYAs receiving NUDGE will then begin receiving intervention content for 6 months. AYAs randomized to control will receive NUDGE at the conclusion of the Month 3 study visit. Study visits will occur at Months 0, 3, and 6 with staff masked to treatment assignment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 003780A122 | OTHER_GRANT | Cystic Fibrosis Foundation | View |