Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis (Be In Charge)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cystic Fibrosis |
Behavioral: Web Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis |
- 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.
- Change in Weight [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]Change in weight from baseline to 10 weeks
- 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
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: Web Intervention
Behavioral
Other Name: Be In Charge
|
|
No Intervention: Usual Care
Participants will receive usual care and be assessed at baseline and week 10 for study outcomes.
|
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| Ages Eligible for Study: | 4 Years to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45239 | |
| Contact: Cindy Scharf 513-636-3931 Cynthia.Scharf@cchmc.org | |
| Principal Investigator: Lori J Stark, Ph.D. | |
| Principal Investigator: | Lori Stark, Ph.D. | Children's Hospital Medical Center, Cincinnati |
More Information
No publications provided
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01686672 History of Changes |
| Other Study ID Numbers: | 2012-0467 |
| Study First Received: | September 13, 2012 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
Cystic Fibrosis Behavioral Intervention Children |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013