NCT Number: NCT06616857
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
Interested in participating?
Request Info13 year–25 year
All sexes
Interventional
Not applicable
Jacksonville, Florida, 32207, United States
Location status: Recruiting
Charles McCaslin, MD
SUB_INVESTIGATOR
Christopher Cushing, PhD
SUB_INVESTIGATOR
David Fedele, PhD
CONTACT
David Fedele, PhD
PRINCIPAL_INVESTIGATOR
Diego De La Cruz, M.S
CONTACT
Kamyar Arasteh, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals in this condition will receive intervention content to promote physical activity.
Individuals will receive educational materials about how to increase physical activity
Time frame: Baseline
Recruitment: Our recruitment goal is 30 AYAs with CF.
Time frame: 3-month
Retention: Our criterion for success is no more than 20% attrition.
Time frame: 3-month
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.
Time frame: 3-month
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.
Time frame: Baseline, 3-month, and 6-month
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.
Time frame: Baseline, 3-month, and 6-month
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.
Time frame: Baseline, 3-month, and 6-month
AYA CF-related quality of life will be assessed via the Cystic Fibrosis Questionnaire-Revised.
Nemours Children's Clinic
Other
Acronym: NUDGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07314229
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Lille, France
View Trial DetailsNCT07071324
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Denver, Colorado, United States
View Trial DetailsNCT07157644
Abnormalities, Multiple, Behavior
Ankara, Çankaya, Turkey (Türkiye)
View Trial DetailsNCT07027553
Behavior, Cardiovascular Disease Risk Factors
Bath, United Kingdom
View Trial Details