CF Wellness Program

Recruiting

CF Wellness Program: ORBIT Phase 2 Pilot RCT

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

1. ≥18 years old
2. Documentation of CF diagnosis in the medical record
3. Score of \>4 on the Fatigue Severity Scale
4. Access to a smartphone, tablet, and/or computer with access to internet
5. Ability to understand/read/speak English
6. Receives CF care at a participating CF Center

Exclusion Criteria:

1. Pulmonary exacerbation (physician determined and may include oral antibiotics, IV antibiotics, hospitalization) ±14 days of enrollment
2. Pregnant or \<6 months post-partum (self-reported)
3. Contraindication to light physical activity (as determined by the treating physician and may include pulmonary, cardiovascular, or musculoskeletal contraindications)
4. Participated in the CFWP Feasibility Study
5. Currently enrolled in another interventional trial
6. Unavailable to complete coaching sessions within the study timeframe

About the study

This study is a pilot randomized control trial (RCT; N=80) comparing the Cystic Fibrosis Wellness Program (CFWP) to usual care (UC) to evaluate (1) Intervention Adherence (completion of the CFWP Coaching Sessions) (2) Study Retention (completion of the Week 15 assessment) and (3) Data Quality (valid daytime and nighttime fitness tracker data). A secondary aim is to gather preliminary data to determine if the CFWP has a clinically significant signal over usual care to improve fatigue, sleep, and physical activity (PA) and reduce sedentary behavior.

What is being tested

CF Wellness Program (behavioral)

Sponsor: Johns Hopkins University · Participants: 80 · Started: Feb 3, 2026

Contact the study team

Kristin Riekert, PhD · Phone: 4105507755

Official record on ClinicalTrials.gov — NCT07071324

Locations in the U.S.

Colorado	National Jewish Health, Denver (Not yet recruiting)
Maryland	Johns Hopkins University, Baltimore
Massachusetts	Boston Children's Hospital, Boston (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.