Cystic FibrosisBe In ChargeNCT01686672
Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
A study testing Web Intervention in people with Cystic Fibrosis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This study will demonstrate feasibility and collect pilot data via a pilot randomized trial of 20 participants on the effectiveness of a web-based delivery system of behavioral plus nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of age that has been found to be efficacious… Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Web Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2014
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Cystic Fibrosis
- Ages 4 to 9 year
- below the 50th percentile for body mass index for age and gender
- and their parents
Who cannot join
- medical condition that would affect diet or growth (e.g., type 1 diabetes mellitus)
- significant developmental delays
- a sputum culture positive for Burkholderia cepacia
- a forced expiratory volume in the first second of expiration (FEV1) of less than 40%
- receiving enteral or parenteral nutrition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45239
About this study
This study will demonstrate feasibility and collect pilot data via a pilot randomized trial of 20 participants on the effectiveness of a web-based delivery system of behavioral plus nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of age that has been found to be efficacious in face to face delivery.
Read the detailed description
Optimizing nutritional status and growth improves health outcomes and survival in children with cystic fibrosis (CF). Better pulmonary function, as measured by forced expiratory rate in 1 second (FEV1), is associated with body mass index (BMI) above the 50th percentile for age and gender for children with CF1. Evidence based practice guidelines recommend that nutritional treatment for children with CF ages 2 to 20 years should aim to achieve and maintain a BMI > 50th percentile, however across 117 CF centers in the United States 57% of girls and 56% of boys failed to meet this recommendation1. The investigators have developed a highly effective behavioral plus nutrition intervention (BE IN CHARGE) and demonstrated its efficacy when delivered face-to-face to produce weight gain and its superiority over nutrition education alone. Although endorsed by the CF Foundation as an evidence-based treatment, it is not available to most CF Centers or families due to lack of trained personnel, cost, and distance issues. With funding from the CF Foundation the investigators developed a web-based delivery system of their efficacious behavioral plus nutrition intervention for parents of children with CF ages 4 to 9 years of age. Using a Place Outcomes Award the investigators have conducted beta testing of the web-intervention and made appropriate modifications. The current study represents the next steps in refining and testing our web-based intervention. This study will demonstrate feasibility and collect pilot data on the effectiveness of the intervention in a pilot randomized trial of 20 treatment naïve participants.
- Conditions
- Cystic Fibrosis
- Being tested
- Web Intervention
- Keywords
- Cystic Fibrosis, Behavioral Intervention, Children
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web InterventionBehavioural
Also called Be In Charge
Behavioral
| Study group | Role | What they receive |
|---|---|---|
| Web Intervention | Experimental | BeInCharge has two components: an electronic diet tracker and a 7 session intervention. The 7 treatment sessions are designed to be completed over a 7 to 10 week period. Each treatment module includes both a nutrition education and child behavior management component. Treatment sessions should be completed every 7 to 10 days, while the electronic diet tracker requires daily input. Receives: Behavioral: Web Intervention |
| Usual Care | No intervention | Participants will receive usual care and be assessed at baseline and week 10 for study outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Daily Caloric Intake
Change in average daily caloric intake at baseline and 10 weeks.
Measured: Baseline and 10 weeks
Secondary outcomes (1)
Change in Weight
Change in weight from baseline to 10 weeks
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Stark, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686672
- Sponsor's protocol ID
- 2012-0467
- Acronym
- Be In Charge
- Status last verified
- Oct 2014
- First submitted
- 13 Sep 2012
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01686672
- Acronym / sponsor ID
- Be In Charge / 2012-0467
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Behavioral Intervention, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Sep 2012 (estimated)
- 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.
This study will demonstrate feasibility and collect pilot data via a pilot randomized trial of 20 participants on the effectiveness of a web-based delivery system of behavioral plus nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of age that has been found to be efficacious in face to face delivery.
Detailed description
Optimizing nutritional status and growth improves health outcomes and survival in children with cystic fibrosis (CF). Better pulmonary function, as measured by forced expiratory rate in 1 second (FEV1), is associated with body mass index (BMI) above the 50th percentile for age and gender for children with CF1. Evidence based practice guidelines recommend that nutritional treatment for children with CF ages 2 to 20 years should aim to achieve and maintain a BMI > 50th percentile, however across 117 CF centers in the United States 57% of girls and 56% of boys failed to meet this recommendation1. The investigators have developed a highly effective behavioral plus nutrition intervention (BE IN CHARGE) and demonstrated its efficacy when delivered face-to-face to produce weight gain and its superiority over nutrition education alone. Although endorsed by the CF Foundation as an evidence-based treatment, it is not available to most CF Centers or families due to lack of trained personnel, cost, and distance issues. With funding from the CF Foundation the investigators developed a web-based delivery system of their efficacious behavioral plus nutrition intervention for parents of children with CF ages 4 to 9 years of age. Using a Place Outcomes Award the investigators have conducted beta testing of the web-intervention and made appropriate modifications. The current study represents the next steps in refining and testing our web-based intervention. This study will demonstrate feasibility and collect pilot data on the effectiveness of the intervention in a pilot randomized trial of 20 treatment naïve participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web Intervention | Experimental | Behavioral: Web InterventionBeInCharge has two components: an electronic diet tracker and a 7 session intervention. The 7 treatment sessions are designed to be completed over a 7 to 10 week period. Each treatment module includes both a nutrition education and child behavior management component. Treatment sessions should be completed every 7 to 10 days, while the electronic diet tracker requires daily input. |
| Usual Care | No intervention | –Participants will receive usual care and be assessed at baseline and week 10 for study outcomes. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical diagnosis of Cystic Fibrosis
- Ages 4 to 9 year
- below the 50th percentile for body mass index for age and gender
- and their parents
Key exclusion criteria (5 listed)
- medical condition that would affect diet or growth (e.g., type 1 diabetes mellitus)
- significant developmental delays
- a sputum culture positive for Burkholderia cepacia
- a forced expiratory volume in the first second of expiration (FEV1) of less than 40%
- receiving enteral or parenteral nutrition.
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 |
|---|---|---|
| Web InterventionAlso: Be In ChargeBehavioral | Behavioural | Web Intervention |
Primary outcome
Change in Average Daily Caloric Intake
Time frame: Baseline and 10 weeks
Change in average daily caloric intake at baseline and 10 weeks.
1 secondary outcome
Change in Weight
Time frame: Baseline and 10 weeks
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 21 Oct 2014.
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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.
Lori Stark, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web Intervention in people with Cystic Fibrosis, run by Children's Hospital Medical Center, Cincinnati at 1 site 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 4 inclusion and 5 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 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Average Daily Caloric Intake (time frame: Baseline and 10 weeks). 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 21 Oct 2014.