This trial is active, not recruiting.

Condition cystic fibrosis
Treatment web intervention
Sponsor Children's Hospital Medical Center, Cincinnati
Start date October 2012
End date September 2013
Trial size 12 participants
Trial identifier NCT01686672, 2012-0467


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
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.
web intervention Be In Charge
(No Intervention)
Participants will receive usual care and be assessed at baseline and week 10 for study outcomes.

Primary Outcomes

Change in Average Daily Caloric Intake
time frame: Baseline and 10 weeks

Secondary Outcomes

Change in Weight
time frame: Baseline and 10 weeks

Eligibility Criteria

Male or female participants from 4 years up to 9 years old.

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.

Additional Information

Official title Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis
Principal investigator Lori Stark, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.