Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis (Be In Charge)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01686672
First received: September 13, 2012
Last updated: May 13, 2014
Last verified: May 2014

September 13, 2012
May 13, 2014
October 2012
September 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01686672 on ClinicalTrials.gov Archive Site
Change in Weight [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
Change in weight from baseline to 10 weeks
Same as current
  • 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
Same as current
 
Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cystic Fibrosis
Behavioral: Web Intervention
Behavioral
Other Name: Be In Charge
  • 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.
    Intervention: Behavioral: Web Intervention
  • No Intervention: Usual Care
    Participants will receive usual care and be assessed at baseline and week 10 for study outcomes.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
September 2014
September 2013   (final data collection date for primary outcome measure)

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.
Both
4 Years to 9 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01686672
2012-0467
No
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Lori Stark, Ph.D. Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP