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

NCT ID: NCT03635762

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2020-12-31

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.

Conditions

Cystic Fibrosis in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Be In Charge

behavioral + nutrition education program

Group Type: EXPERIMENTAL

Be In Charge

Intervention Type: BEHAVIORAL

comparison of pre and post-program weight and calorie intake

Interventions

Be In Charge

comparison of pre and post-program weight and calorie intake

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gregory Sawicki

Co-Chair of Success with Therapies Research Consortium

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Opipari, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Lucile Packard Children's Hospital Stanford

Stanford, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Boston Childrens Hospital

Boston, Massachusetts, United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

University of Texas- Southwestern

Dallas, Texas, United States

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Countries

United States

Other Identifiers

STRC- 117-18-02

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-P00028680

Identifier Type: -

Identifier Source: org_study_id