Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis

NCT ID: NCT01686672

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Web Intervention

Intervention Type: BEHAVIORAL

Behavioral

Usual Care

Participants will receive usual care and be assessed at baseline and week 10 for study outcomes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Web Intervention

Behavioral

Intervention Type: BEHAVIORAL

Other Intervention Names

Be In Charge

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Stark, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2012-0467

Identifier Type: -

Identifier Source: org_study_id