Clinical trial NCT03635762: Developing e-Health Systems to Improve Growth and Nutrition in CF
Official title: DESIGN CF: Developing e-Health Systems to Improve Growth and Nutrition in CF Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis in Children
Keywords: Nutrition
Behavioral Intervention
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: Johns Hopkins University
name: Children's Hospital Medical Center, Cincinnati
First posted: 2018-08-17
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in weight pre- to post-treatment
timeFrame: Baseline and Post-Treatment Assessment (approx. Week 10)
measure: Change in caloric intake pre- to post-treatment
timeFrame: Completion of BeInCharge.org Module 1 (approx. week 1) and Completion of BeInCharge.org Module 7 (approx. week 7)
Secondary outcomes:
measure: Change in percentage of the Estimate Energy Requirement pre- to post-treatment
timeFrame: Completion of BeInCharge.org Module 1 (approx. week 1) and Completion of BeInCharge.org Module 7 (approx. week 7)
measure: Change in Body Mass Index z-score pre- to post-treatment
timeFrame: Baseline and Post-Treatment Assessment (approx. Week 10)
measure: Percent eligible participants with access to technology
timeFrame: up to day 1
measure: Percent eligible participants who agree to use the BeInCharge program
timeFrame: up to day 1
measure: Average number of minutes for clinicians to introduce Be In Charge program to participant
timeFrame: Baseline
measure: Percent of participants that begin registration for BeInCharge.org program
timeFrame: Start of BeInCharge.org registration (approx. 1 day)
measure: Percent of participants who complete registration for BeInCharge.org program
timeFrame: Completion of BeInCharge.org registration (approx. 1 day)
measure: Percent of participants who complete BeInCharge.org program
timeFrame: Completion of BeInCharge.org (approx. week 7)
measure: BeInCharge.org program Ease of Use for clinicians assessed by Likert scale
timeFrame: Post-Treatment (approx. Week 10)
measure: Clinician satisfaction with using the BeInCharge.org program with each specific patient assessed by Likert scale
timeFrame: Post-Treatment (approx. Week 10)
measure: Participant satisfaction with using the BeInCharge.org program assessed by Likert scale
timeFrame: Post-Treatment (approx. Week 10)
Other outcomes:
measure: Percent of participants that finish BeInCharge.org program registration on the same day as started
timeFrame: Completion of BeInCharge.org registration (approx. 1 day)
measure: Average number of days between completing BeInCharge.org program registration and starting first program module
timeFrame: Start of BeInCharge.org Module 1 (approx. 1 week)
measure: Percent of participants that complete first program module within 1 week
timeFrame: Completion of BeInCharge.org Module 1 (approx. 1 week)
measure: Percent of participants that complete first program module within 1 day
timeFrame: Completion of BeInCharge.org Module 1 (approx. 1 day)
measure: Average number of BeInCharge.org program modules completed within 28 days of registration
timeFrame: BeInCharge.org registration completion to Day 28
measure: Average number of days to complete BeInCharge.org program
timeFrame: Completion of BeInCharge.org Module (approx. week 7)
measure: Percent of days with entries in the study food tracking mobile application
timeFrame: Start of BeInCharge.org Module 7 (approx. week 7)
measure: Percent of participants that start program module 2 within 10 days of completing module 1
timeFrame: Start of BeInCharge.org Module 2 (approx. weeks 2-3)
measure: Percent of patients for whom a clinician reports reviewing BeInCharge.org program data prior to or during post-program visit
timeFrame: Post-Treatment Assessment (approx. week 10)
measure: 3. Percent of clinicians that login to the Be In Charge Clinician dashboard weekly
timeFrame: Post-Treatment Assessment (approx. week 10)
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: University of Texas- Southwestern
state: Texas
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU
state: Virginia
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lisa Opipari, PhD
role: PRINCIPAL_INVESTIGATOR
References: