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

NCT03635762 | Completed

• 2 other identifiers: IRB-P00028680STRC- 117-18-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 7

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. 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. 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. 3.Demonstrate sustainability of the Be In Charge program through effective use by participants and clinicians.

Conditions

Cystic Fibrosis in Children

Keywords

Nutrition; Behavioral Intervention

Outcome Measures

Primary Outcomes (2)

• Change in weight pre- to post-treatment

  Weight measured in kilograms in CF Clinic at beginning and end of treatment program

  Baseline and Post-Treatment Assessment (approx. Week 10)

• Change in caloric intake pre- to post-treatment

  Parent-reported average daily caloric intake calculated from food and beverages entered into study diet tracking mobile application between modules 1-2 and modules 6-7 of program

  Completion of BeInCharge.org Module 1 (approx. week 1) and Completion of BeInCharge.org Module 7 (approx. week 7)

Secondary Outcomes (11)

• Change in percentage of the Estimate Energy Requirement pre- to post-treatment

  Completion of BeInCharge.org Module 1 (approx. week 1) and Completion of BeInCharge.org Module 7 (approx. week 7)

• Change in Body Mass Index z-score pre- to post-treatment

  Baseline and Post-Treatment Assessment (approx. Week 10)

• Percent eligible participants with access to technology

  up to day 1

• Percent eligible participants who agree to use the BeInCharge program

  up to day 1

• Average number of minutes for clinicians to introduce Be In Charge program to participant

  Baseline

Other Outcomes (10)

• Percent of participants that finish BeInCharge.org program registration on the same day as started

  Completion of BeInCharge.org registration (approx. 1 day)

• Average number of days between completing BeInCharge.org program registration and starting first program module

  Start of BeInCharge.org Module 1 (approx. 1 week)

• Percent of participants that complete first program module within 1 week

  Completion of BeInCharge.org Module 1 (approx. 1 week)

Study Arms (1)

Be In Charge

EXPERIMENTAL

behavioral + nutrition education program

Behavioral: Be In Charge

Interventions

Be In Charge BEHAVIORAL

comparison of pre and post-program weight and calorie intake

Be In Charge

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child with CF should:
• 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:
• Sweat chloride equal to or greater than 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis test (QPIT)
• two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
• Be between the ages of 3 - 10 years at the time of enrollment
• 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:
• 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)
• Be a primary caregiver who is routinely involved in and has primary responsibility for mealtimes with their child
• Be willing to use Be in Charge and have clinical care team review progress

You may not qualify if:

• The child with CF should not:
• Have a medical condition that would affect diet or growth (e.g., CF related diabetes)
• Be receiving parenteral nutrition or nutritional supplements via a feeding tube (e.g G-tube, J-tube, nasogastric tube) at time of enrollment
• Have a significant developmental disability/delay
• Have a sputum culture positive for Burkholderia Cepacia
• 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:
• Are unable to speak or read English.
• Have a major psychiatric disorder or disability that would interfere with their ability to use the program or participate in the study.
• Participated in Phase I of the DESIGN CF study.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Cystic Fibrosis Foundation: collaborator
• Johns Hopkins University: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (7)

Lucile Packard Children's Hospital Stanford

Stanford, California, 94304, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

University of Texas- Southwestern

Dallas, Texas, 75235, United States

Location

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Interventions

Fees and Charges

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Lisa Opipari, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Chair of Success with Therapies Research Consortium

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 17, 2018
• Study Start: December 7, 2018
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)