NCT01686672

Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
BEHAVIORAL	Web Intervention	Behavioral

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-09-01
• Completion: 2014-10-01
• First posted: 2012-09-18
• Last updated: 2014-10-21

Locations

1 site across 1 country: United States