Cystic Fibrosis in ChildrenNCT03635762
Developing e-Health Systems to Improve Growth and Nutrition in CF
A study testing Be In Charge in people with Cystic Fibrosis in Children, run by Boston Children's Hospital at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- Be In Charge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Dec 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
Boston Childrens Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
University of Texas- Southwestern
Dallas, Texas, 75235
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219
Lucile Packard Children's Hospital Stanford
Stanford, California, 94304
About this study
Official title: 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.
Read more
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:
- 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.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- Be In Charge
- Keywords
- Nutrition, Behavioral Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be In ChargeBehavioural
comparison of pre and post-program weight and calorie intake
| Study group | Role | What they receive |
|---|---|---|
| Be In Charge | Experimental | behavioral + nutrition education program Receives: Behavioral: Be In Charge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight pre- to post-treatment
Weight measured in kilograms in CF Clinic at beginning and end of treatment program
Measured: 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
Measured: 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
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
Measured: 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
Measured: 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)
Measured: up to day 1
Percent eligible participants who agree to use the BeInCharge program
Based on participant enrollment in study
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-Treatment (approx. Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start7 Dec 2018
- Primary completion31 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Johns Hopkins University, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Gregory Sawicki, Boston Children's Hospital
- Investigators
- Lisa Opipari, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635762
- Sponsor's protocol ID
- IRB-P00028680
- Other IDs
- STRC- 117-18-02
- Status last verified
- Feb 2021
- First submitted
- 18 Jul 2018
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESIGN CF: Developing e-Health Systems to Improve Growth and Nutrition in CF Phase 2
- ClinicalTrials.gov ID
- NCT03635762
- Acronym / sponsor ID
- IRB-P00028680
- Conditions
- Cystic Fibrosis in Children
- Keywords
- Nutrition, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Johns Hopkins University, Children's Hospital Medical Center, Cincinnati
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Be In Charge | Experimental | Behavioral: Be In Chargebehavioral + nutrition education program |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
- 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
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Be In Chargecomparison of pre and post-program weight and calorie intake | Behavioural | Be In Charge |
Primary outcome
Change in weight pre- to post-treatment
Time frame: Baseline and Post-Treatment Assessment (approx. Week 10)
Weight measured in kilograms in CF Clinic at beginning and end of treatment program
Change in caloric intake pre- to post-treatment
Time frame: Completion of BeInCharge.org Module 1 (approx. week 1) and Completion of BeInCharge.org Module 7 (approx. week 7)
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
11 secondary outcomes
Change in percentage of the Estimate Energy Requirement pre- to post-treatment
Time frame: 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
Time frame: Baseline and Post-Treatment Assessment (approx. Week 10)
Percent eligible participants with access to technology
Time frame: up to day 1
Percent eligible participants who agree to use the BeInCharge program
Time frame: up to day 1
Average number of minutes for clinicians to introduce Be In Charge program to participant
Time frame: Baseline
Percent of participants that begin registration for BeInCharge.org program
Time frame: Start of BeInCharge.org registration (approx. 1 day)
Percent of participants who complete registration for BeInCharge.org program
Time frame: Completion of BeInCharge.org registration (approx. 1 day)
Percent of participants who complete BeInCharge.org program
Time frame: Completion of BeInCharge.org (approx. week 7)
BeInCharge.org program Ease of Use for clinicians assessed by Likert scale
Time frame: Post-Treatment (approx. Week 10)
Clinician satisfaction with using the BeInCharge.org program with each specific patient assessed by Likert scale
Time frame: Post-Treatment (approx. Week 10)
Participant satisfaction with using the BeInCharge.org program assessed by Likert scale
Time frame: Post-Treatment (approx. Week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Opipari, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be In Charge in people with Cystic Fibrosis in Children, run by Boston Children's Hospital at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight pre- to post-treatment (time frame: Baseline and Post-Treatment Assessment (approx. Week 10)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.