Clinical trial NCT01686672: Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
Official title: Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Behavioral Intervention
Children
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Average Daily Caloric Intake
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline and 10 weeks
Other outcomes:
measure: Use of web-based intervention
timeFrame: 10 weeks
measure: Treatment Satisfaction
timeFrame: 10 weeks
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lori Stark, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: