Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Behavioral Intervention, Children
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.
Interventions
BEHAVIORALWeb Intervention
Behavioral
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Caloric Intake | Baseline and 10 weeks | Change in average daily caloric intake at baseline and 10 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | Baseline and 10 weeks | Change in weight from baseline to 10 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of web-based intervention | 10 weeks | 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 | 10 weeks | Assessment of participant's satisfaction with the intervention and web-site |
Countries
United States
Outcome results
None listed