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Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT ID: NCT06616857

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2026-07-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Cystic Fibrosis (CF)

Keywords

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physical activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NUDGE

Group Type EXPERIMENTAL

NUDGE

Intervention Type BEHAVIORAL

Individuals in this condition will receive intervention content to promote physical activity.

Education

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

Individuals will receive educational materials about how to increase physical activity

Interventions

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NUDGE

Individuals in this condition will receive intervention content to promote physical activity.

Intervention Type BEHAVIORAL

Education

Individuals will receive educational materials about how to increase physical activity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 13-25 years old
2. Has a verified CF diagnosis or CF-related disorder
3. Medically stable (i.e., FEV1\>30%, not experiencing a CF-related exacerbation)
4. Speaks and reads English

Exclusion Criteria

1. Have a comorbidity limiting PA participation (e.g., neurological condition)
2. Have a significant cognitive impairment that interferes with study completion
3. Have any oxygen, CPAP or BiPAP requirement
Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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David Fedele

Principal Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nemours Childrens Health

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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David Fedele, PhD

Role: primary

Diego De La Cruz, M.S

Role: backup

Other Identifiers

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003780A122

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2158063

Identifier Type: -

Identifier Source: org_study_id