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NCT03635762 · ClinicalTrials.gov registry record · NA
Developing e-Health Systems to Improve Growth and Nutrition in CF
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT03635762: Completed NA study, sponsored by Boston Children's Hospital.
NCT03635762 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635762, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study Summary
Being at or above the 50th percentile body mass index (BMI) for age and gender in children with cystic fibrosis (CF) is associated with better lung functioning as measured by FEV1, yet diet is one of the least adhered to components of the CF treatment regimen. Investigators at Cincinnati Children's Hospital Medical Center (CCHMC) have developed an efficacious behavioral plus nutrition education program (Be In Charge) that improves adherence to dietary recommendations, and promotes weight gain in children with CF. To make Be In Charge (BIC) widely available to families of children with CF ages 3 to 10 years, the investigators translated the face-to-face intervention into a 10-week, web-based intervention (BeInCharge.org). The investigators tested it in a pilot study and the results were promising. In the first phase of the current study, the investigators worked with a team of clinicians, parents and technology developers to extend the usability and functionality of the web intervention, enable parent-clinician collaboration, and support concurrent use across multiple clinical sites. The long term goal of this research is to make BeInCharge.org available through CF Centers across the country to patients that would benefit in order to improve dietary adherence. The current phase of this protocol is a prospective, multicenter, nonrandomized study enrolling up to 150 parents of children with CF. Participants will complete the Be In Charge program outside of CF clinic on their own time. CF Center clinicians will be able to follow the participant's progress via the Be In Charge clinician dashboard. CF center clinicians will be asked to support participating families in completing the program as clinically appropriate. The primary study objective is to: 1\. Demonstrate preliminary effectiveness on weight and calorie intake outcomes when the Be In Charge program is integrated into clinical care with implementation support for care teams. The secondary study objectives
Primary Outcome
Weight measured in kilograms in CF Clinic at beginning and end of treatment program
Interventions
- BEHAVIORAL Be In Charge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-12-07 |
| Est. Completion | 2020-12-31 |
| Phase | NA |
What the finished NCT03635762 record still lists
NCT03635762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Be In Charge is the first listed.
NCT03635762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03635762 about?
NCT03635762 is a clinical study titled "Developing e-Health Systems to Improve Growth and Nutrition in CF". Being at or above the 50th percentile body mass index (BMI) for age and gender in children with cystic fibrosis (CF) is associated with better lung functioning as measured by FEV1, yet diet is one of the least adhered to components of the CF treatment regimen. Investigators at Cincinnati Children's ...
What is the current status of trial NCT03635762?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2018-12-07. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03635762?
The interventions under investigation include: Be In Charge (BEHAVIORAL).
Who is sponsoring clinical trial NCT03635762?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03635762's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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