Cystic Fibrosis (CF)NUDGENCT06616857
Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
A study testing NUDGE and Education in people with Cystic Fibrosis (CF), run by Nemours Children's Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- NUDGE and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 13-25 years old
- Has a verified CF diagnosis or CF-related disorder
- Medically stable (i.e., FEV1\>30%, not experiencing a CF-related exacerbation)
- Speaks and reads English
Who cannot join
- Have a comorbidity limiting PA participation (e.g., neurological condition)
- Have a significant cognitive impairment that interferes with study completion
- Have any oxygen, CPAP or BiPAP requirement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Childrens Health
Jacksonville, Florida, 32207
David Fedele, PhD, 904-544-1464, david.fedele@nemours.org
Diego De La Cruz, M.S, 904-820-7161, diego.delacruz@nemours.org
About this study
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
Read the 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.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- NUDGE, Education
- Keywords
- physical activity
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUDGEBehavioural
Individuals in this condition will receive intervention content to promote physical activity.
EducationOther
Individuals will receive educational materials about how to increase physical activity
| Study group | Role | What they receive |
|---|---|---|
| NUDGE | Experimental | Not described Receives: Behavioral: NUDGE |
| Education | Active comparator | Not described Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment: Our recruitment goal is 30 AYAs with CF.
Measured: Baseline
Retention
Retention: Our criterion for success is no more than 20% attrition.
Measured: 3-month
Engagement
Engagement: We will be considered engagement a success if AYAs in NUDGE respond to an average of 4/7 (57%) messages each week during the first 3 months that a participant uses NUDGE.
Measured: 3-month
Acceptability
Acceptability: We will consider NUDGE acceptable if users report a satisfaction rating of ≥3 (mostly satisfied) on our modified Client Satisfaction Questionnaire and rate it as usable as ≥70% of other computerized systems on the System Usability Scale. We will also be attentive to themes in relation to the barriers and facilitators of using NUDGE and its success in promoting PA in interviews.
Measured: 3-month
Secondary outcomes (3)
Actigraphy
We will objectively measure AYA's moderate-to-vigorous PA for 7-days via ActiGraph wGT3X-BT accelerometers. All data will be processed using Actilife software. We will remove periods of non-wear and sleep; days with >10-hours of valid data during waking hours will be retained. Data will be binned into 15 second epochs and processed using the Chandler algorithm.
Measured: Baseline, 3-month, and 6-month
Lung Functioning
Lung function will be assessed for 7-days via the AM1+ portable spirometer. AYAs will undergo a standardize training and complete three maximal effort blows every morning and evening. The main outcomes will be forced expiratory volume in one second (FEV1) percent predicted.
Measured: Baseline, 3-month, and 6-month
CF Quality of Life
AYA CF-related quality of life will be assessed via the Cystic Fibrosis Questionnaire-Revised.
Measured: Baseline, 3-month, and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start18 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, David Fedele, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616857
- Sponsor's protocol ID
- 2158063
- Other IDs
- 003780A122
- Acronym
- NUDGE
- Status last verified
- Jun 2026
- First submitted
- 20 Sep 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plans to share IPD will need to be discussed with the IRB.