Recruiting

Mobile Health Platform

Sponsor:

Nemours Children's Clinic

Code:

NCT06616857

Conditions

Cystic Fibrosis (CF)

Eligibility Criteria

Sex: All

Age: 13 - 25

Healthy Volunteers: Not accepted

Interventions

NUDGE

Education

Study Details

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

Conditions

Cystic Fibrosis (CF)

Study ID

NCT06616857

Start date

Feb 18, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NUDGE

active comparator: Education

Interventions

NUDGE

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

Education

Individuals will receive educational materials about how to increase physical activity

Primary outcome measure

  • Recruitment [ Time Frame: Baseline ]
  • Retention [ Time Frame: 3-month ]
  • Engagement [ Time Frame: 3-month ]
  • Acceptability [ Time Frame: 3-month ]

Central Contacts and Locations

Locations

Nemours Childrens Health

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

David Fedele, PhD

904-544-1464david.fedele@nemours.org

Diego De La Cruz, M.S

904-820-7161diego.delacruz@nemours.org

Principal Investigator:

David Fedele, PhD

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • physical activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-06-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.