Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis (Be In Charge)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01686672|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : October 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Behavioral: Web Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2014|
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
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.
- Change in Average Daily Caloric Intake [ Time Frame: Baseline and 10 weeks ]Change in average daily caloric intake at baseline and 10 weeks.
- Change in Weight [ Time Frame: Baseline and 10 weeks ]Change in weight from baseline to 10 weeks
- Use of web-based intervention [ Time Frame: 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 [ Time Frame: 10 weeks ]Assessment of participant's satisfaction with the intervention and web-site
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686672
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45239|
|Principal Investigator:||Lori Stark, Ph.D.||Children's Hospital Medical Center, Cincinnati|