NCT03635762

Developing e-Health Systems to Improve Growth and Nutrition in CF

Completed NA Last updated 2 February 2021

What this trial tests

NA trial testing Be In Charge in Cystic Fibrosis in Children in 64 participants. Completed in 31 December 2020.

Timeline

7 December 2018

Primary endpoint
31 August 2020

31 December 2020

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	64
Start date	7 December 2018
Primary completion	31 August 2020
Estimated completion	31 December 2020
Sites	7 locations across United States

Drugs / interventions tested

• Be In Charge

Conditions studied

• Cystic Fibrosis in Children — all drugs for Cystic Fibrosis in Children →

Sponsor

Boston Children's Hospital

Who can join

Adults 3 to 10, any sex, with Cystic Fibrosis in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 are to:

1. Develop a well-defined, tested set of implementation strategies consolidated into a change package and an optimized technology platform that will support a dissemination trial for spreading the Be In Charge program across CF Centers.
2. Demonstrate that it is feasible and acceptable to use the Be In Charge program in clinical care and with fidelity to intervention parameters.
3. Demonstrate sustainability of the Be In Charge program through effective use by participants and clinicians.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.