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

Cystic Fibrosis Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686672
• Other study ID #: 2012-0467
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: October 17, 2014
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 in face to face delivery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 9 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Web Intervention
Behavioral

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of web-based intervention	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	10 weeks	No
Other	Treatment Satisfaction	Assessment of participant's satisfaction with the intervention and web-site	10 weeks	No
Primary	Change in Average Daily Caloric Intake	Change in average daily caloric intake at baseline and 10 weeks.	Baseline and 10 weeks	No
Secondary	Change in Weight	Change in weight from baseline to 10 weeks	Baseline and 10 weeks	No