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

NCT06616857 | Recruiting DMC

• 2 other identifiers: 2158063003780A122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Keywords

physical activity

Outcome Measures

Primary Outcomes (4)

• Recruitment

  Recruitment: Our recruitment goal is 30 AYAs with CF.

  Baseline

• Retention

  Retention: Our criterion for success is no more than 20% attrition.

  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.

  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.

  3-month

Secondary Outcomes (3)

• Actigraphy

  Baseline, 3-month, and 6-month

• Lung Functioning

  Baseline, 3-month, and 6-month

• CF Quality of Life

  Baseline, 3-month, and 6-month

Study Arms (2)

NUDGE

EXPERIMENTAL

Behavioral: NUDGE

Education

ACTIVE COMPARATOR

Other: Education

Interventions

NUDGE BEHAVIORAL

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

NUDGE

Education OTHER

Individuals will receive educational materials about how to increase physical activity

Education

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Nemours Childrens Health

Jacksonville, Florida, 32207, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 27, 2024
• Study Start: February 18, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-02

Locations

US (1)