Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis (Be In Charge)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis|
- Change in Average Daily Caloric Intake [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]Change in average daily caloric intake at baseline and 10 weeks.
- Change in Weight [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]Change in weight from baseline to 10 weeks
- Use of web-based intervention [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Ongoing use of web-intervention collected electronically via the web to include sign on, duration of time on web, page views, and completion of activities on the web-site
- Treatment Satisfaction [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Assessment of participant's satisfaction with the intervention and web-site
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Web Intervention
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.
Behavioral: Web Intervention
Other Name: Be In Charge
No Intervention: Usual Care
Participants will receive usual care and be assessed at baseline and week 10 for study outcomes.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686672
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45239|
|Principal Investigator:||Lori Stark, Ph.D.||Children's Hospital Medical Center, Cincinnati|