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

Status:	Recruiting
Conditions:	Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	3 - 10
Updated:	2/1/2019
Start Date:	December 7, 2018
End Date:	December 2020
Contact:	Jonathan Greenberg
Email:	jonathan.greenberg@childrens.harvard.edu
Phone:	617-355-3197

DESIGN CF: Developing e-Health Systems to Improve Growth and Nutrition in CF Phase 2

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 objectives are to:

1. Demonstrate that it is feasible and acceptable to use the Be In Charge program in
clinical care and with fidelity to intervention parameters.

2. Demonstrate preliminary effectiveness on calorie intake and weight outcomes when the Be
In Charge program is integrated into clinical care with implementation support for care
teams.

The secondary objective is to 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.

Inclusion Criteria:

The child with CF should:

1. Have documentation of a CF diagnosis as evidenced by one or more clinical features
consistent with the CF phenotype or one or more of the following criteria:

1. Sweat chloride equal to or greater than 60 milliequivalents per liter (mEq/L) by
quantitative pilocarpine iontophoresis test (QPIT)

2. two well-characterized mutations in the cystic fibrosis transmembrane conductance
regulator (CFTR) gene

2. Be between the ages of 3 - 10 years at the time of enrollment

3. Be below the 50th percentile BMI and/or would benefit from behavioral strategies to
address mealtime behaviors/have a history of struggling with recommended nutritional
intake as determined by the physician, dietitian , psychologist, or other CF Care team
member

The parent or legal authorized representative should:

4. Have regular access to a desktop device with internet or an iOS or Android mobile
device with internet (tablet with internet or smartphone with a data plan)

5. Be a primary caregiver who is routinely involved in and has primary responsibility for
mealtimes with their child

6. Be willing to use Be in Charge and have clinical care team review progress

Exclusion Criteria:

The child with CF should not:

1. Have a medical condition that would affect diet or growth (e.g., CF related diabetes)

2. Be receiving parenteral nutrition or nutritional supplements via a feeding tube (e.g
G-tube, J-tube, nasogastric tube) at time of enrollment

3. Have a significant developmental disability/delay

4. Have a sputum culture positive for Burkholderia Cepacia

5. Have a forced expiratory volume in the first second of expiration (FEV1) of less than
40% Predicted if the child is able to reliably perform spirometry according to
American Thoracic Society (ATS) guidelines.

Parents/legal authorized representatives will be excluded if they:

6. Are unable to speak or read English.

7. Have a major psychiatric disorder or disability that would interfere with their
ability to use the program or participate in the study.

8. Participated in Phase I of the DESIGN CF study.

We found this trial at

sites

Children's Hospital of Richmond at VCU

Richmond, Virginia 23298

Principal Investigator: Michael Schechter, MD, MPH

from

Richmond, VA