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

Study Overview
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Brief Summary
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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: 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. Demonstrate that it is feasible and acceptable to use the Be In Charge program in clinical care and with fidelity to intervention parameters. Demonstrate sustainability of the Be In Charge program through effective use by participants and clinicians.

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

Conditions
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Cystic Fibrosis in Children

Intervention / Treatment
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* Behavioral: Be In Charge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Be In Charge<br>behavioral + nutrition education program | Behavioral: Be In Charge<br>* comparison of pre and post-program weight and calorie intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percentage of the Estimate Energy Requirement pre- to post-treatment | Average percentage of Estimated Energy Requirement consumed per day at beginning and end of treatment calculated using age, gender, activity level and parent-reported daily caloric intake data from food and beverage 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) | 
| Change in Body Mass Index z-score pre- to post-treatment | Body Mass Index z-scores calculated from weight, height, age and gender based on Center for Disease Control growth charts | Baseline and Post-Treatment Assessment (approx. Week 10) | 
| Percent eligible participants with access to technology | Participant self-report of 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) | up to day 1 | 
| Percent eligible participants who agree to use the BeInCharge program | Based on participant enrollment in study | up to day 1 | 
| Average number of minutes for clinicians to introduce Be In Charge program to participant | Clinician self-report of time spent during clinic visit introducing the BeInCharge program and discussing its use in the patient's care, collected at end of baseline clinic visit | Baseline | 
| Percent of participants that begin registration for BeInCharge.org program | Collected from BeInCharge.org platform user metrics and based on date of enrollment and date of completion of first screen of program (set password screen) | Start of BeInCharge.org registration (approx. 1 day) | 
| Percent of participants who complete registration for BeInCharge.org program | Collected from BeinCharge.org platform user metrics and based on date of enrollment and date of completion of last program registration screen (tutorials screen) | Completion of BeInCharge.org registration (approx. 1 day) | 
| Percent of participants who complete BeInCharge.org program | Collected from BeInCharge.org platform user metrics and based on completion of final screen of final module (module 7, congratulations screen) | Completion of BeInCharge.org (approx. week 7) | 
| BeInCharge.org program Ease of Use for clinicians assessed by Likert scale | Clinician single-item self-report to the question, How easy was it to use BIC.org with [patient name]? assessed by 5-point Likert scale. Values range from 1-5 with higher values indicating greater ease of use. Collected at the end of the program for each patient. | Post-Treatment (approx. Week 10) | 
| Clinician satisfaction with using the BeInCharge.org program with each specific patient assessed by Likert scale | Clinician single-item self-report to the question How satisfied were you with using BIC.org with [patient name]? assessed by 5-point Likert scale. Values range from 1-5 with higher values indicating greater satisfaction. Collected at the end of the program for each patient. | Post-Treatment (approx. Week 10) | 
| Participant satisfaction with using the BeInCharge.org program assessed by Likert scale | Participant single-item self-report to the question How satisfied were you with BIC.org? assessed by 5-point Likert scale. Values range from 1-5 with higher values indicating greater satisfaction. Collected at the end of the program for each participant. | Post-Treatment (approx. Week 10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Behavioral Intervention