Health TrialsbyHealthPanel

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

ConditionCystic Fibrosis (CF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-25
SponsorNemours Children's Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • NUDGE

    Behavioral

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

  • Education

    Other intervention

    Individuals will receive educational materials about how to increase physical activity

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: NUDGEExperimental treatment 1 intervention
Group B: EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment

Recruitment: Our recruitment goal is 30 AYAs with CF.

Time frame
Baseline
2

Retention

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

Time frame
3-month
3

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.

Time frame
3-month
4

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.

Time frame
3-month

Secondary outcomes

1

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.

Time frame
Baseline, 3-month, and 6-month
2

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.

Time frame
Baseline, 3-month, and 6-month
3

CF Quality of Life

AYA CF-related quality of life will be assessed via the Cystic Fibrosis Questionnaire-Revised.

Time frame
Baseline, 3-month, and 6-month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nemours Children's Clinic

Lead sponsor

Cystic Fibrosis Foundation

Collaborator

Source ClinicalTrials.gov
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