Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
Be In Charge
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 21, 2014
October 1, 2014
11 months
September 13, 2012
October 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Average Daily Caloric Intake
Change in average daily caloric intake at baseline and 10 weeks.
Baseline and 10 weeks
Secondary Outcomes (1)
Change in Weight
Baseline and 10 weeks
Other Outcomes (2)
Use of web-based intervention
10 weeks
Treatment Satisfaction
10 weeks
Study Arms (2)
Web Intervention
EXPERIMENTALBeInCharge 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.
Usual Care
NO INTERVENTIONParticipants will receive usual care and be assessed at baseline and week 10 for study outcomes.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Stark, Ph.D.
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2012
First Posted
September 18, 2012
Study Start
October 1, 2012
Primary Completion
September 1, 2013
Study Completion
October 1, 2014
Last Updated
October 21, 2014
Record last verified: 2014-10